Patients must not be on therapeutic anti-coagulation; prophylactic anti-coagulation (i.e., intraluminal heparin) of venous or arterial access devices is allowed
Patients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.
Patient not on anticoagulation has acceptable coagulation studies (obtained < days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) below or within normal limits (+%). Patients on anticoagulation must have coagulation values within the therapeutic range appropriate for the anti-coagulation indication.
Subjects currently on anti-coagulation therapy are not eligible
Abnormal bleeding times or active anti-coagulation therapy
Requires continuous anti-coagulation or anti-platelet therapy that cannot be safely interrupted to allow for IT injection and/or history of coagulopathy.
Patients on therapeutic anti-coagulation are eligible if there is no bleeding and they are on a stable dose of anti-coagulation therapy (e.g., on coumadin with an international normalized ratio [INR] of to ) for at least days before registration (prior to the start of therapy)
Patients who require ongoing anticoagulation will be excluded. Only aspirin will be permitted. Pre and post-surgical prophylactic anti-coagulation treatment is permitted
Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded
No ongoing anti-coagulation and/or anti-platelet therapies allowed
Patients must not be on therapeutic anti-coagulation; prophylactic anticoagulation (i.e. low dose warfarin) of venous or arterial devices is allowed provided that the requirements for PT, INR, and PTT are met
Patients receiving anti-coagulation therapy are eligible as long as anti-coagulation regimen has been stable for > month
Patients who require ongoing anticoagulation will be excluded; only aspirin will be permitted; pre and post-surgical prophylactic anti-coagulation treatment is permitted
Patients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.
Patients who require the use of therapeutic anti-coagulation: except as required to maintain patency of preexisting permanent vascular catheter
Use of full dose, therapeutic anti-coagulation or patients with uncontrolled coagulopathy or bleeding disorder
Currently requiring any type of full-dose anti-coagulation treatment, systemic administration of antibiotics or chronic administration of anti-viral agents
Concurrent anti-coagulation therapy
History of venous thrombosis currently requiring anti-coagulation therapy
History of venous thrombosis currently requiring anti-coagulation therapy
Patients on therapeutic dose anti-coagulation with warfarin, low molecular weight heparin (LMWH), or other anti-coagulants will be allowed to participate in the study; however, the anti-coagulants should be held pre- and post- research biopsy (when applicable) as per institutional standards; the risks of a temporary hold of anti-coagulation should be carefully considered and explained to the patient as part of the informed consent process; if it is not felt to be in the best interest of the patient to have anti-coagulation held, the patient may still enter the study, but should not undergo a research biopsy
Patients with a history of deep vein thrombosis must be on anti-coagulation therapy prior to enrollment; patients requiring prophylactic anti-coagulation are eligible
Patients receiving anti-coagulation therapy are excluded
Participants who need to take therapeutic anti-coagulation or anti-platelet therapy.
Patient on anti-coagulation therapy and are unable to stop therapy for the perioperative period
Requires therapeutic anti-coagulation
No anti-coagulation therapy is allowed with the exception of low-dose aspirin
The patient is receiving full dose subcutaneous heparins or is under anti-coagulation treatment.
No use of full dose, therapeutic anti-coagulation with warfarin or related anti-coagulants or unfractionated or low molecular weight heparins.
Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy