PROCOAG
Trial question
What is the role of four-factor prothrombin complex concentrate in patients with trauma at risk of massive transfusion?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 324
324 patients (91 female, 233 male).
Inclusion criteria: adult patients with trauma at risk of massive transfusion.
Key exclusion criteria: traumatic cardiac arrest before randomization; devastating injuries expected to die within the first hour of admission; preinjury treatment with anticoagulants; preinjury terminal condition.
Interventions
N=164 four-factor prothrombin complex concentrate (intravenous administration of 1 mL/kg; 25 IU of factor IX/kg).
N=160 placebo (intravenous administration of 1 mL/kg of saline solution).
Primary outcome
Total blood product consumption at 24 hours
12 IU
11 IU
12.0 IU
9.0 IU
6.0 IU
3.0 IU
0.0 IU
Four-factor prothrombin complex
concentrate
Placebo
No significant
difference ↔
No significant difference in total blood product consumption at 24 hours (12 IU vs. 11 IU; AD 0.2 IU, 95% CI -2.99 to 3.33).
Secondary outcomes
No significant difference in RBC consumption (6 IU vs. 6 IU; AD -0.3 IU, 95% CI -1.8 to 1.3).
No significant difference in death at day 28 (17% vs. 21%; ARD -3, 95% CI -12 to 5).
No significant difference in hospital-free days through day 28 (6.5 days vs. 7 days; AD -0.15 days, 95% CI -1.65 to 1.35).
Safety outcomes
No significant differences in superficial venous thrombosis, DVT, PE, stroke.
Significant difference in ≥ 1 thromboembolic event (35% vs. 24%).
Conclusion
In adult patients with trauma at risk of massive transfusion, four-factor prothrombin complex concentrate was not superior to placebo with respect to total blood product consumption at 24 hours.
Reference
Pierre Bouzat, Jonathan Charbit, Paer-Selim Abback et al. 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 Apr 25;329(16):1367-1375.
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