Grant: Operating Grant

Frozen plasma is commonly transfused to patients with abnormal coagulation results prior to medical procedures associated with a risk of bleeding (e.g. involving a needle or incision). The most frequent group that requires frozen plasma transfusions are patients admitted to an intensive care unit. These patients frequently have abnormal coagulation tests and also freqently require invasive medical procedures that can be associated with bleeding.While frozen plasma transfusions can improve abnormal coagulation test results, there is no evidence to suggest that prophylactic frozen plasma transfusions will reduce bleeding associated with medical procedures in patients with mild coagulation abnormalities. Additionally, we know that important adverse complications occur with FP transfusions. We will undertake a pilot randomized controlled trial in non-bleeding ICU patients who require an invasive medical procedure (central venous catheterization, chest tube, thoracentesis, paracentesis, biopsy, fluid drainage) in 3 Canadian hospitals. Patients with an abnormal coagulation test (INR between 1.5 to 2.5)abnormal coagulation test (INR between 1.5 to 2.5) will receive a frozen plasma transfusion or no treatment prior to an invasive procedure. The primary outcome for this pilot study will be feasibility (the number of patients we are able to enroll per month). Other important outcomes will include those that will be evaluated in the definitive trial including bleeding post procedure, red cell transfusions, adverse transfusion reactions, mortality and hospital length of stay. We plan to enroll 80 patients over 2 years in 3 Canadian hospitals.