Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma - PROCOAG
Contribution To Literature:
The PROCOAG trial failed to show that 4F-PCC reduces transfusion requirements among trauma patients.
Description:
The goal of the trial was to evaluate 4-factor prothrombin complex concentrate (4F-PCC) compared with placebo among trauma patients at risk of massive transfusion.
Study Design
- Randomization
- Parallel
- Placebo
Trauma patients were randomized to 4F-PCC (n = 165) vs. placebo (n = 162).
- Total number of enrollees: 327
- Duration of follow-up: In-hospital
- Mean patient age: 39.5 years
- Percentage female: 29%
Inclusion criteria:
- Patients (≥18 years of age) with trauma at risk of massive transfusion
Exclusion criteria:
- Traumatic cardiac arrest
- Devastating injuries with expected death within an hour or preinjury terminal condition
- Secondary admission from another health care facility
- Preinjury treatment with anticoagulants
- Known pregnancy
- Known hypersensitivity to 4F-PCC
- Patient under guardianship
- Inclusion in another trial within the last 30 days
- Patients without health insurance
Principal Findings:
The primary outcome, total blood product consumption, was a median of 12 units in the 4F-PCC group vs. 11 units in the placebo group (p = 0.72).
Secondary outcomes:
- At least 1 thromboembolic event: 35% in the 4F-PCC group vs. 24% in the placebo group (p = 0.03)
Interpretation:
Among patients with trauma, 4F-PCC failed to reduce the need for blood product transfusion. Moreover, 4F-PCC was associated with an increased risk of thromboembolic events. This trial does not support the systematic use of 4F-PCC in patients at risk of massive transfusion.
References:
Bouzat P, Charbit J, Abback PS, et al., on behalf of the PROCOAG Study Group. Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial. JAMA 2023;Mar 21:[Epub ahead of print].
Clinical Topics: Anticoagulation Management, Prevention
Keywords: Anticoagulants, Emergency Medicine, Factor Xa Inhibitors, Hemorrhage, Platelet Transfusion, Prothrombin, Risk, Secondary Prevention, Thromboembolism
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