Transfusion of Plasma Prior to Invasive Procedures Pilot Trial (TOPPIT)

Summary

Frozen plasma (FP) 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 FP transfusions are patients admitted to an intensive care unit. These patients frequently have abnormal coagulation tests and also frequently require invasive medical procedures that can be associated with bleeding. While FP transfusions can improve abnormal coagulation test results, there is no evidence to suggest that prophylactic FP transfusions will reduce bleeding associated with medical procedures in patients with mild coagulation abnormalities. Additionally, it is known that important adverse complications occur with FP transfusions. The investigators will undertake a pilot randomized controlled trial in non-bleeding ICU patients who require an invasive medical procedure (central venous catheterization, chest tube, thoracocentesis, paracentesis, biopsy, fluid drainage) in 3 Canadian hospitals. Patients with an abnormal coagulation test (INR between 1.5 to 2.5) will receive a FP transfusion or no treatment prior to an invasive procedure. The primary outcome for this pilot study will be feasibility (the number of patients enrolled 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. The objective of the study is to enrol 80 patients over 2 years in 3 Canadian hospitals.

Timeline

Start

2016-01

Primary completion

2018-08

Completion

2019-02

Drugs

Indications