Outcome
Fibrinogen N=220 Placebo N=210
OR [95%CI]
P-value
Primary outcome Failure, N (%) 88 (40.0%) 89 (42.4%) 0.99 [0.66; 1.47] 0.96*
Secondary outcomes RBC Transfusion ≥ 2 Units from H0 to D2, N (%) 51 (23.4%) 52 (25.0%) 1.00 [0.63; 1.60] 0.98*
RBC Transfusion ≥ 4 Units from H0 to D2, N (%) 6 (2.7%) 5 (2.4%) 0.87#
Number of RBC units per transfused patient from H0 to D2, mean ±SD 2.7 ± 1.2 3.1 ± 2.5 0.99£
Hb loss ≥ 4 g/dL from reference level to D2, N (%) 42 (19.1%) 41 (19.5%) 1.02 [0.62;1.67] 0.95*
Hb loss ≥ 3 g/dL from reference level to D2, N (%) 102 (46.4%) 98 (46.9%) 0.91#
Hb loss ≥ 4 g/dL from H0 to D2, N (%) 16 (7.3%) 17 (8.3%) 0.69#
Hb level < 9 g/dL from reference level to D2, N (%) 112 (50.9%) 117 (56.0%) 0.29#
Total blood loss (from baseline to D2), mean ± SD, mL 1555 ± 849 1723 ± 1193 0.21£
Additional blood loss (from H0 to D2), mean ± SD, mL 304.7 ± 386.2 319.7 ± 417.1 0.33£
Intrauterine balloon, N (%) 63 (28.6%) 61 (29.0%) 0.93#
At least one rescue procedure, N (%) 65 (29.5%) 64 (30.5%) 0.83#
At least one invasive hemostatic procedure, N (%), including: 8 (3.6%) 10 (4.8%) 0.56#
Arterial embolization 6 (2.7%) 10 (4.8%) 0.27#
Arterial ligation 0 (0%) 0 (0%) -
Hysterectomy 0 (0%) 1 (0.5%) 0.49$
Intensive care or resuscitation, N (%) 62 (28.2%) 54 (25.7%) 0.56#
Length of stay in intensive care or resuscitation unit, mean ± SD, day 0.7 ± 0.6 0.7 ± 0.9 0.84£
SOFA score of patients admitted to intensive care or resuscitation unit, median [min; max] 0 [0;4] 0 [0;6] 0.32£
Death, N (%) 0 (0%) 0 (0%) -