6/29/23, 1:44 AM PROCOAG Pathway Feedback Search Clinical Topics Home Studies PROCOAG PROCOAG Disease Traumatic hemorrhage Trial question What is the role of four-factor PCC in patients with trauma at risk of massive transfusion? Study design Multi-center Double blinded RCT Population Characteristics of study participants 28.0% female N = 324 72.0% male 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 PCC (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 https://web.pathway.md/studies/rec4G6hz3VLA5oSpb 1/2 6/29/23, 1:44 AM PROCOAG Pathway 12.0 IU 12 11 9.0 IU 6.0 IU 3.0 IU No significant difference 0.0 IU Four-factor prothrombin complex concentrate Placebo 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, deep vein thrombosis, PE, stroke. Significant difference in 1 thromboembolic event (35% vs. 24%). Conclusion In adult patients with trauma at risk of massive transfusion, four-factor PCC 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. Open reference URL https://web.pathway.md/studies/rec4G6hz3VLA5oSpb 2/2