Hemorrhagic Shock Clinical Trial
Official title:
Formula-driven vs Laboratory-guided Transfusion Practices in Bleeding Trauma Patients: A Feasibility Randomized Controlled Study
Background: Bleeding and coagulopathy still accounts for the majority of early in-hospital
deaths following trauma. There have been lately several published studies suggesting that
higher transfusion ratios of fresh frozen plasma (FFP), platelets (PTL) and cryoprecipitate
(CRYO) to red blood cell (RBC) are associated with survival advantages. However, the
evidence comes from retrospective data limited by a significant number of unaddressed
confounders. In addition, the use of blood products bears known and important risks of
complications.
Hypothesis: The adoption of a formula-driven transfusion practice with pre-defined ratios of
FFP to PTL to RBC transfusion (1:1:1) is feasible and superior to current laboratory-guided
transfusion practice in treating and/or preventing early coagulopathy improving survival
rates in massively bleeding trauma patients .
Objective: To exam the feasibility of implementing a pre-defined ratio of FFP to PTL to RBC
(1:1:1) transfusion protocol and its impact on a population of bleeding trauma patients.
Design: A two-year pilot feasibility randomized control trial at Sunnybrook Health Sciences
Centre. Randomization: 70 patients are expected to be randomized to lab-driven or to
formula-driven massive transfusion protocol and followed-up to 28 days or hospital
discharge.
Study outcomes: protocol violation; in-hospital mortality by exsanguination; death at 28
days; coagulation competence defined by current standard coagulation tests (INR & PTT < 1.5
times normal; PTL ≥ 50 and Fibrinogen ≥ 1.0) or clotting factor levels ≥ 30%; correlation of
current standard coagulation tests with clotting factors levels; cessation of bleeding;
incidence of ALI, sepsis, MOF, transfusion-related circulatory overload, transfusion
reactions; Ventilator-free days; ICU & Hospital LOS; thromboembolic events.
Intervention protocol: Transfusion of pre-defined ratios of FFP and PTL to RBC (1:1:1)
(formula-driven) for the first 12h of hospitalization without coagulation tests guidance
while patient is hemorrhaging or before if bleeding stops.
Statistical analysis: protocol compliance rate and in-hospital mortality rates within 24h
and at 28 days will be assessed using Chi-square test. ROC analysis will be used to analyze
coagulation competence.
Main expected outcomes: implementation of a formula-driven transfusion protocol is feasible
and coagulation competence will be achieved faster and more efficiently in the study group.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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