Adequate blood coagulation function
Acceptable coagulation profile
Adequate coagulation function
Normal coagulation profile
Adequate coagulation functioning within days prior to study registration defined by either of the following criteria:
Normal coagulation panel.
Have acceptable coagulation parameters defined as:
Adequate coagulation function
Adequate coagulation profile.
Adequate coagulation profile:
Have adequate coagulation functioning within days prior to start of study treatment, defined by either of the following criteria:
Hematologic (Coagulation Factors):
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study)
Clinically significant coagulation disorder
No history of a coagulation disorder
Hepatic insufficiency not due to tumor resulting in clinical jaundice or bilirubin >. x ULN and/or coagulation defects
Clinically apparent jaundice and/or known coagulation defects
Hematologic (Coagulation Factors):
Have adequate coagulation function.
Acceptable coagulation profile
Abnormal coagulation parameters
Coagulation function tests not suggestive of severe liver dysfunction
Coagulation:
Hepatic insufficiency resulting in clinical jaundice and/or Coagulation defects
Abnormal and clinical significant coagulation parameters at the discretion of the Investigator, i.e.:
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for additional liver function tests and coagulation parameters are not required for entry into this protocol
Known past or current coagulation defects.
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Adequate coagulation function
Adequate hematologic, organ, and coagulation within weeks ( days) prior to randomization.
Adequate coagulation functioning within days prior to registration for protocol therapy defined by either of the following criteria:
Adequate coagulation
Adequate coagulation parameters (within days prior to registration)
Have adequate coagulation functioning within days prior to start of study treatment, defined by either of the following criteria:
Coagulation
Normal coagulation panel.
Normal coagulation profile as evidenced by PT and aPTT ? . x ULN;
Normal Coagulation profile.
Congenital coagulation abnormalities
Normal platelet count and coagulation profile
Adequate coagulation function as defined by the following criteria:
Adequate coagulation status
History or suspicion of a congenital or acquired coagulation disorder.
Known past or current coagulation defects.
Coagulation status:
for intratumoral cohort, coagulation profile favorable to surgery
Thrombocytopenia (platelet count < K) or coagulation disorder that would contraindicate intramuscular injection
History of bleeding/coagulation problems
Adequate coagulation defined as: