[c09aa8]: / clusters / 9knumclustersv2 / clust_2255.txt

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No concurrent anticoagulation with warfarin or heparin/heparin analogues, clopidogrel, oral direct thrombin inhibitors, or direct factor XA inhibitors
Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin; low molecular weight heparin is permitted for prophylactic or therapeutic use; factor X inhibitors are permitted\r\n* NOTE: Warfarin may not be started while enrolled in the EAY study\r\n* Stopping the anticoagulation for biopsy should be per site standard operating procedure (SOP)
Patients must be able and willing to receive prophylaxis with daily aspirin, low molecular weight heparin, factor X inhibitors or warfarin if randomized to lenalidomide; patients must also be willing to receive pneumocystis jirovecii prophylaxis with sulfamethoxazole/trimethoprim, dapsone, atovaquone or inhaled pentamidine, in the event that they are randomized to TGR-; patients unable or unwilling to take any listed prophylaxis are NOT eligible
Treatment with systemic anticoagulation (e.g. warfarin, heparin, low molecular weight heparin, anti-Xa inhibitors, etc.) except aspirin
Required concurrent use of anti-coagulants or anti-platelet medication, with the exception of aspirin doses ? mg/day, low-dose SC heparin or SC low-molecular-weight heparin for DVT prophylaxis, or heparin flushes to maintain IV catheter patency
Patients may NOT be on full dose anti-coagulation therapy; maintenance doses of low molecular weight heparin is permissible
Contraindication to any of the required concomitant drugs, including proton-pump inhibitor (e.g. lansoprazole), enteric-coated aspirin or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
Participants should not take drugs that directly and durably inhibit coagulation with the exception of warfarin (coumadin) and heparin including low-molecular-weight heparin (LMWH), including enoxaparin, tinzaparin, etc
Known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
Patients who require concurrent treatment with antithrombotic and/or anti-platelet agents (e.g., warfarin, heparin, low molecular weight heparin, aspirin, and/or ibuprofen)
Anticoagulation with low-molecular-weight heparin (LMWH) will be permitted; patients receiving treatment with warfarin or any of the new oral anticoagulants (NOACs) (rivaroxaban, apixaban, dabigatran, or edoxaban) will be given the option to switch to LMWH
for subjects receiving anticoagulant, the subjects must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for subjects on warfarin should be in the therapeutic range. Low molecular weight heparin (LMWH) is allowed.
The patient requires therapeutic doses of any anticoagulant, including low molecular weight heparin (LMWH). Concomitant use of warfarin, even at prophylactic doses, is prohibited.
Heparin, warfarin or similar anti-coagulants (except. low molecular weight heparin for treatment/prophylaxis) currently or w/in wks of study drug
Use of anticoagulants (e.g., warfarin, heparin) at therapeutic levels within days prior to the first dose of GSK. Low dose (prophylactic) low molecular weight heparin (LMWH) is permitted. In addition, INR must be monitored in accordance with local institutional practices, as appropriate.
If they are on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, antiplatelet agents and full dose aspirin within days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
Warfarin (any dose) or full-dose anticoagulation with other agents (low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin) within days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
Thrombotic disorders or use of anticoagulants, such as warfarin, requiring therapeutic international normalized ratio (INR) monitoring; (treatment with low molecular weight heparin (LMWH) or direct acting oral anti-coagulants is allowed)
Patients receiving anticoagulation or anti-platelet therapy are excluded; excluded agents include heparin or low molecular weight heparin, warfarin, clopidogrel, ibuprofen and other nonsteroidal anti-inflammatory drug (NSAIDS), tirofiban, and other anticoagulants, drugs, or herbal supplements that affect platelet function; administration of heparin to keep subject's infusion lines patent is allowed; low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter are allowed; aspirin will not be allowed within days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention, may resume a low dose (i.e., maximum mg QD) of aspirin if platelet counts are stable (>= ,/mm^) through weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor
Patients on coumadin must be willing to switch to an alternative subcutaneous low-molecular-weight heparin (LMWH) or oral agent (at principal investigator [PI] discretion exceptions can be permitted, as determined on a case by case basis and documented)
If patients require anticoagulation while on protocol, they should be switched from warfarin to another alternative anticoagulant such as low molecular weight heparin or oral direct factor Xa inhibitors as deemed appropriate by the treating physician for the duration they are on capecitabine (must be switched at least week prior to starting capecitabine) to avoid drug-drug interaction of warfarin with capecitabine
OR for subjects receiving warfarin or low molecular weight heparin (LMWH), the subjects must, in the Investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed . ULN if that is the goal of anticoagulant therapy.
Patients may not receive Coumadin while on study; patients may receive low molecular weight heparin or novel oral anticoagulants (eg. dabigatran, apixaban, rivaroxaban) provided that the dose is held - days before injections are given and biopsies are performed per the protocol; anti-platelet agents and herbal substances are allowed at the discretion of the treating endoscopist
Coagulopathy, including the use of Coumadin or heparin anticoagulants that cannot be discontinued for the cryoablation procedure; NOTE: heparin for line patency without detectable lab abnormalities for coagulation will be allowed
Receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug
Receiving any of the following medications:\r\n* Therapeutic doses of any anticoagulant, including low-molecular weight heparin (LMWH); concomitant use of warfarin, even at prophylactic doses, is prohibited\r\n* Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids\r\n* Colony-stimulating factors (CSFs) that cannot be held during the monitoring period for dose-limiting toxicities (DLT)
International normalized ratio (INR) =< .\r\n* Use of rivaroxaban, apixaban, edoxaban or warfarin is an exclusion criteria; therapy with heparin, low molecular weight heparin (LMWH), dabigatran or fondaparinux is allowed
Known adverse reactions to heparin (heparin-induced thrombocytopenia or any allergy)
Require therapeutic use of anticoagulants other than daily aspirin or low molecular weight heparin
Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration (INR) monitoring; (treatment with low molecular weight heparin [LMWH] is allowed)
Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis or requirement for systemic anticoagulation with unfractionated heparin, low-molecular-weight heparin or heparin fractions (eg, enoxaparin, dalteparin, fondaparinux) or oral anticoagulants (eg, apixaban, rivaroxaban, dabigatran etexilate, warfarin). Note: Use of heparin or thrombolytic agents for local maintenance or clearance of a central venous catheter is permitted.
Warfarin is not permitted; prophylactic or therapeutic use of low molecular-weight heparin (e.g., enoxaparin) or direct thrombin inhibitors are permitted
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range INR (between and ) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
Unable to tolerate thromboembolic prophylaxis including, as clinically indicated, aspirin, Coumadin (warfarin) or dose adjusted low-molecular weight heparin
Therapeutic anticoagulation, including but not limited to: low-molecular weight heparin (LMWH), heparin, or warfarin; anticoagulants must be discontinued days prior to the first administration of bevacizumab; prophylactic use of anticoagulants is allowed
Abnormality in coagulation parameters. Received oral or parenteral anticoagulants or thrombolytic agents within days of the first dose of trial drug. Low dose high molecular weight heparin is permitted if international normalized ratio is within the normal range
Patients must not be on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin within days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
Anticoagulants/anti-platelets: patients on therapeutic (treatment) dose of anticoagulants (e.g. warfarin, low molecular-weight heparin) are not eligible; patients are not allowed to take aspirin, clopidogrel, ticlopidine, Aggrenox; patients on prophylactic anticoagulation may be enrolled and treated on study as long as their platelet count is monitored closely and maintained at > , while they are receiving dasatinib
International normalized ratio (INR): =< . (patients on warfarin need to be converted to low-molecular-weight heparin [LMWH] during study participation to be eligible)
Patients who are receiving any anti-coagulation or anti-platelet therapy including, but not limited to, Clopidogrel, vitamin K antagonists (e.g. warfarin) , heparin, low molecular weight heparin, dabigatran, rivaroxaban, and apixaban
Concurrent or recent (within month) use of thrombolytic agents, or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters). Of note, therapy with low-molecular weight heparin is acceptable as long as the INR < ..
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range international normalized ratio (INR) (maximum [max] =< ) on a stable dose of oral anticoagulant for greater than month or on a stable dose of low molecular weight heparin
Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin; use of aspirin is not an exclusion criteria
Contraindication to any of the required concomitant drugs, including proton pump inhibitor (e.g. lansoprazole), enteric coated aspirin or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
Patients requiring warfarin therapy are excluded, low molecular weight heparin is permitted
Patients with a history of hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
No warfarin therapy; low molecular weight heparin anticoagulation is permitted provided that patients have been clinically stable on anti-coagulation for at least weeks prior to day of study drug and meet platelet inclusion criteria; no history of active gastrointestinal (GI) bleeding or other major bleeding within previous months prior to day of study drug
Requires anticoagulation that cannot be discontinued prior to biopsy\r\n* Note: Exception if able to hold antiplatelet agents days prior to the injections and biopsy\r\n* NOTE: Low molecular weight heparin (LMWH) will be allowed for bridging if on warfarin\r\n* NOTE: Heparin for line patency without detectable lab abnormalities for coagulation will be allowed
administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than hours before randomization;
Treatment with unfractionated heparin; patients taking an anticoagulant must use warfarin or a low molecular weight heparin
Patient receiving active treatment of anticoagulants (i.e. warfarin, low molecular weight heparins)
If they are on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin within days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
Patients may not be on warfarin, factor Xa inhibitors and direct thrombin inhibitors; Note: low molecular weight heparin and prophylactic low dose warfarin are permitted; APTT/PTT must meet the inclusion criteria; subjects taking warfarin must have their international normalized ratio (INR) followed closely
Current use of warfarin, factor Xa inhibitors and direct thrombin inhibitors; Note: low molecular weight heparin and prophylactic low dose warfarin are permitted; PT/PTT must meet the inclusion criteria; subjects taking warfarin must have their INR followed closely
Patients may not be on coumarin anti-coagulants (warfarin, etc.); heparin, low-molecular weight heparin (LMWH), or other antithrombotic medications are permitted
TUMOR BIOPSY SEQUENCING: Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted for prophylactic or therapeutic use
TREATMENT: Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted for prophylactic or therapeutic use
Patients receiving anticoagulation or anti-platelet therapy are excluded due to the risk of thrombocytopenia with navitoclax\r\n* Excluded agents include heparin or low molecular weight heparin, warfarin, clopidogrel, ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDS), tirofiban, and other anticoagulants, drugs, or herbal supplements that affect platelet function\r\n* Administration of heparin to keep subject's infusion lines patent is allowed; low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter are allowed\r\n* Aspirin will not be allowed within days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention, may resume a low dose (i.e., maximum mg once daily [QD]) of aspirin if platelet counts are stable (>= ,/mm) through weeks of navitoclax administration \r\n* All decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor
Concurrent use of anti-coagulants (warfarin, etc.) other than low-molecular weight heparin (LMWH); medication must be stopped before time of registration; if patient has recently been on anti-coagulants other than LMWH, patient must have international normalized ratio (INR) =<
Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted for prophylactic or therapeutic use; low-dose warfarin (=< mg/day) is permitted
Current treatment or treatment within days of screening with a vitamin K\n antagonist, such as warfarin. Patients who require anticoagulation due to their\n central line may receive an alternative agent, such as low molecular weight heparin\n (LMWH).
Activated partial thromboplastin time (APTT) < . times upper limit of normal (ULN); (Note: use of warfarin is prohibited; low molecular weight heparin is allowed, so long as these criteria are met)
International normalized ratio (INR) < . times ULN; (Note: use of warfarin is prohibited; low molecular weight heparin is allowed, so long as these criteria are met)
Any of the following conditions: \r\n* Serious or non-healing wound, ulcer, or bone fracture\r\n* Current use of therapeutic warfarin; Note: low molecular weight heparin is allowed; prothrombin time (PT)/partial thromboplastin time (PTT) must meet the inclusion criteria\r\n* History of bleeding disorder, including patients afflicted with hemophilia, disseminated intravascular coagulation, or any other abnormality of coagulation potentially predisposing patients to bleeding\r\n* History of hemoptysis in excess of . mL (/ teaspoon ) within weeks prior to first dose of study drug\r\n* Poorly controlled depression or anxiety disorder, or recent (=< months) suicidal ideation\r\n* HIV-positive patients on combination antiretroviral therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
Patients who require heparin (other than low-molecular weight heparin)
Inability to comply with an anti-thrombotic treatment regimen (e.g., administration of aspirin, enoxaparin, or low molecular weight heparin administration [type Innohep or equivalent])
Is unable or unwilling to undergo thromboembolic prophylaxis including, as clinically indicated, aspirin, Coumadin (warfarin) or low-molecular weight heparin.
Inability to comply with an anti-thrombotic treatment regimen (e.g., administration of aspirin, enoxaparin, or low molecular weight heparin administration)
Anti-coagulation therapy. Aspirin, other anti-platelet agents, and low molecular weight heparin are permitted unless the investigator deems the patient is at a significant risk for bleeding.
Required concurrent use of anti-coagulants or anti-platelet medication, with the exception of aspirin doses ? mg/day, low-dose SC heparin or SC low-molecular-weight heparin for DVT prophylaxis, or heparin flushes to maintain IV catheter patency
Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function with the exception of low dose aspirin (up to mg) and Low-molecular-weight heparin.
Patients must be able to start low-molecular weight heparin, as prophylaxis
Patients are excluded if they have current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin); subjects should have not taken full-dose warfarin or equivalent for at least weeks prior to randomization
Current use of anticoagulants (e.g., warfarin, heparin) at therapeutic levels within days prior to the first dose of GSK. Low dose (prophylactic) low molecular weight heparin (LMWH) is permitted. In addition, INR must be monitored in accordance with local institutional practices.
Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
Patients on Warfarin/Dabigatran/Rivaroxaban anticoagulation may be enrolled for as long as they undergo weekly INR checks for the first months of therapy. a. Patients who switch to low molecular weight heparin may be enrolled and weekly INR labs are not mandated for these patients.
Prophylactic doses of heparin.
The concomitant use of warfarin or other vitamin K antagonists unless felt to be of significant clinical need; low molecular weight heparin or other anticoagulants may be used instead if anticoagulation is required
Use or need for full dose anticoagulation other than low molecular weight heparin and factor Xa inhibitors (e.g. Lovenox, fondaparinux) and no other bleeding risk
Current use or anticipated need for treatment with Coumadin or other agents containing warfarin (except low dose Coumadin [ mg or less daily] administered prophylactically for maintenance of in-dwelling lines or ports); heparin, low molecular weight heparin (LWMH), direct thrombin inhibitors and factor Xa inhibitors are allowed; rivaroxaban should be used with caution; antiplatelet agents are allowed
Patients currently taking anticoagulants (warfarin, heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin])
Bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Treatment with low molecular weight heparin and factor X inhibitors which do not require INR monitoring is permitted. Antiplatelet agents are prohibited throughout the study.
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must have no active bleeding or pathological condition that carries a high risk of bleeding, and must be on a stable dose of oral anticoagulant for days or on a stable dose of low molecular weight heparin for days
For patients requiring anti-coagulation therapy, only therapeutic low molecular weight heparin, direct thrombin inhibitors, or factor Xa inhibitors are permitted
Current use of warfarin, factor Xa inhibitors and direct thrombin inhibitors\r\n* Note: Low molecular weight heparin and prophylactic low dose warfarin are permitted; PT/PTT must meet the inclusion criteria; subjects taking warfarin must have their INR followed closely
Use of warfarin is prohibited; anticoagulation with low-molecular weight heparin (i.e. enoxaparin) or direct thrombin inhibitors is permitted
Current therapy with warfarin or other anticoagulants at therapeutic doses, e.g., low molecular weight heparin, fondaparinux, dabigatran, rivaroxaban, apixaban or edoxaban that are unable to be discontinued
Current use of warfarin (patients will be eligible if warfarin is discontinued and low-molecular weight heparin is used instead)
Contraindication or prior intolerance to thromboembolic prophylaxis with aspirin, warfarin or low-molecular weight heparin
The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must have no active bleeding or pathological condition that carries a high risk of bleeding and must be on a stable dose of oral anticoagulant for days or on a stable dose of low molecular weight heparin for days
International normalized ratio (INR), and prothrombin time (PT) =< . x upper limit of normal (ULN) (patients who are being prophylactically anticoagulated with an agent such as Coumadin or low molecular weight heparin [LMWH] or therapeutically anticoagulated with LMWH will be allowed to participate provided they are stable and monitored at appropriate intervals per institutional guidelines throughout study)
All study participants must be able to tolerate one of the following thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin (coumadin) or alternative anti-coagulant
Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring. (Treatment with low molecular weight heparin is allowed.)
Contraindication to any of the required concomitant drugs, including proton-pump inhibitor (eg, lansoprazole), enteric-coated aspirin, allopurinol or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
Treatment with therapeutic doses of coumarin-type anticoagulants (maximum daily dose of mg allowed for port line patency permitted); low molecular weight heparin (LMWH) will be allowed
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range international normalized ratio (INR) (usually between and ) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, within days prior to registration
Anticoagulants other than low molecular weight heparin.
Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to mg daily are permitted for prophylaxis of thrombosis; note: low molecular weight heparin is permitted provided the patients PT INR is =< .
Patients on warfarin will be excluded from the trial if they cannot be switched to an acceptable alternative medication (i.e. low molecular weight heparin [LMWH]); prolongation of prothrombin time (PT) and International Normalized Ratio (INR) were observed in patients receiving vorinostat concomitantly with coumarin-derivative anticoagulants
Contraindication to aspirin; if unable to take aspirin, contraindication to warfarin or low molecular weight heparin
Current, ongoing treatment with full-dose warfarin; however patients may be on stable doses of a low molecular weight heparin are allowed (i.e. Lovenox)
Patients requiring treatment doses of heparin for any reason; the use of heparin flushes for maintenance of central venous catheters is permitted
Subjects who require heparin other than low-molecular weight heparin
Able to take low molecular weight heparin or warfarin if >= additional risk factor for VTE according to IMW guidelines
Patients receiving current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin) are NOT excluded
Clinically significant bleeding within weeks of screening, current use of warfarin, factor Xa inhibitors, and direct thrombin inhibitors unless these medications can be safely discontinued days prior to AMG- administration; Note: low molecular weight heparin and prophylactic low dose warfarin are permitted; PT/PTT must meet the inclusion criteria; subjects taking warfarin must have their INR followed closely
OR for subjects receiving warfarin or low molecular weight heparin (LMWH), the subjects must, in the Investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed . ULN if that is the goal of anticoagulant therapy.
All study participants must be able to tolerate one of the following thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin (Coumadin) or alternative anti-coagulant
History of adverse reaction to heparin such as heparin-induced thrombocytopenia
Patients on warfarin will not be allowed on the study; patient on low molecular heparin or anti direct factor Xa inhibitor (Xa) drugs will be allowed
Use of warfarin is not allowed; patient is recommended to switch to low molecular weight heparin (LMWH) before participating in this study
Had full-dose anticoagulation with heparin, enoxaparin, dalteparin, other LMWH, a/or other anticoagulants w/in days before first dose of M
SUNITINIB MALATE ARM: Patients who require use of therapeutic doses of Coumarin-derivative anticoagulants such as warfarin are excluded; note: low molecular weight heparin is permitted provided the patients prothrombin time (PT) international normalized ratio (INR) is < .
Coagulopathy, including the use of Coumadin or heparin anticoagulants that cannot be discontinued for the cryoablation procedure; NOTE: heparin for line patency without detectable lab abnormalities for coagulation will be allowed
Participants on any dose of warfarin or are on full dose anticoagulation with other agents including low molecular weight heparin, antithrombin agents, antiplatelet agents and full dose aspirin within days prior to study enrollment; participants on prophylactic doses of low molecular weight heparin are allowed
Patients with known heparin induced thrombocytopenia
Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
Isolated CABG or single valve repair/replacements are allowed only if either (a) AT level is less than % OR (b) preoperative heparin is received (unfractionated heparin [UFH] for at least hours; low- molecular-weight heparin [LMWH] for more than days).
Participants receiving therapeutic anti-coagulation or anti-platelet (anti-aggregant) therapies, except for therapeutic enoxaparin or low dose aspirin. Use of subcutaneous heparin prophylaxis, including low molecular weight heparin is also permitted
A history of heparin-induced thrombocytopenia or hypersensitivity to heparin, enoxaparin, or pork products
Coagulation studies with prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) within normal limits ( %); if the patient is on Coumadin we would switch the patient to low molecular weight (LMW) heparin product such as fondaparinaux (Arixtra) or enoxaprin (Lovenox); an anti-factor Xa test should be available demonstrating adequate anti-coagulation on the low molecular weight heparin (LMWH) (therapeutic range .-.); however, if this is not possible then INR must be kept =<
Current use of anticoagulants at therapeutic doses within days prior to study drug administration. Prophylactic use of unfractioned heparin or low molecular weight heparin is permitted
Subject is currently receiving or requires anticoagulation therapy (e.g., warfarin at any dose) or any drugs (e.g., aspirin, clopidogrel, etc.) or herbal supplements that affect platelet function, with the exception of low molecular weight heparin or heparin that are used to maintain the patency of a catheter
Patients receiving treatment with vitamin K, Coumadin or other agents containing warfarin and heparin. Heparin flush to maintain patency of a central venous access device is allowed.
History of heparin-induced thrombocytopenia.
Patients may not be on anti-coagulants (warfarin, etc.) other than low-molecular weight heparin (LMWH)
Warfarin and its derivatives are not allowed; patient can be receiving low molecular weight heparin if clinically indicated
Patients on full dose anticoagulants or any dose of warfarin; patients on prophylactic dose of low-molecular weight or unfractionated heparin are allowed.
Concurrent use of systemic low molecular weight heparin or low dose warfarin
For those participants receiving warfarin (Coumadin), unfractionated heparin, or low-molecular weight heparin therapy, the applicable coagulation parameter that is being monitored must be within the accepted therapeutic ranges for those indications\r\n* Note: transfusions and/or growth factor dependent participants are not excluded if the above parameters can be achieved with such support
Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
Known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia
Concomitant treatment with any of the following drugs: azathioprine, cyclophosphamide, cyclosporine, pirfenidone, full dose anticoagulation (vitamin K antagonists, dabigatran, heparin), fibrinolysis and high dose anti-platelet therapy (ex. Plavix mg); prophylactic low dose heparin, heparin flush for maintenance of intravenous devices, prophylactic use of anti-platelet therapy (e.g. acetyl salicylic acid up to mg/d, clopidogrel mg/d, or equivalent doses) should be allowed
Low molecular weight heparin or Novel oral anti-coagulant: stable dose within days prior to registration
Current or recent use of dipyridamole, ticlopidine, clopidogrel, cilostazol is excluded; aspirin (=< mg per day) is allowed; prophylactic anticoagulation with oral or parenteral anticoagulants for the patency of venous access devices or other indications is allowed, therapeutic use of low-molecular weight heparin (such as enoxaparin), and factor Xa inhibitors are allowed; use of warfarin is prohibited
History of heparin induced thrombocytopenia
Concomitant treatment with full dose warfarin (coumadin) is NOT allowed; however, treatment with low molecular weight heparin (LMWH) (such as enoxaparin or dalteparin) or rivaroxaban is allowed; patients on full dose warfarin (coumadin) must be transitioned to either LMWH or rivaroxaban prior to administration of any study related drugs
Known allergy to heparin or aspirin or a history of heparin induced thrombocytopenia
Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose; patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate
If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose; patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate
History of allergic reactions attributed to heparin or low molecular weight heparin
History of heparin induced thrombocytopenia
Received any type of pharmacologic thromboprophylaxis (e.g. low molecular weight heparin or heparin) for > hours during current hospitalization
Chronic anti-coagulation with warfarin; patients on low molecular weight heparin or fondaparinux may be enrolled
Current or planned use of anticoagulant drugs such as: warfarin, heparin, low molecular weight heparin, Plavix, or Aggrenox throughout the course of the study
For patients undergoing a research only biopsy: requirement for anticoagulation with heparin, low molecular weight heparin, clopidogrel, rivaroxaban, dabigatran, apixaban, warfarin, aggrenox, fondaparux, ticagrelor, etc (aspirin and other nonsteroidal antiinflammatory drugs [NSAIDs] are ok but should be held prior to biopsy in accordance with institutional standard of care)
Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure
Ongoing therapy with any anticoagulant or antiplatelet agents (example, aspirin, clopidogrel, heparin, or warfarin).