From: High-dose tranexamic acid reduces blood loss in postpartum haemorrhage
Group | TA | Control | P value |
---|---|---|---|
Number of patients | |||
ITT | 77 | 74 | |
Per protocol | 72 | 72 | |
Severe side effects | |||
Deep vein thrombosis, n (%) | |||
ITT | 2 (3) | 1 (1) | 0.4 |
Per protocol | 2 (3) | 1 (1) | 0.37 |
Renal failure, n (%) | |||
ITT | 0 (0) | 0 (0) | - |
Per protocol | 0 (0) | 0 (0) | - |
Mean T4 urea, g/L (± SD) | |||
ITT | 0.17 (0.06) | 0.2 (0.1) | 0.9 |
Per protocol | 0.1 (0.1) | 0.2 (0.1) | 0.9 |
Mean T4 creatininemia, mg/L (± SD) | |||
ITT | 6.3 (1.8) | 6.4 (1.7) | 0.79 |
Per protocol | 5.4 (2.8) | 6.0 (2.3) | 0.7 |
Mean T4 diuresis, mL (± SD) | |||
ITT | 1,058 (1,010) | 882 (480) | 0.25 |
Per protocol | 1,044 (933) | 862 (575) | 0.23 |
Seizures, n (%) | |||
ITT | 0 (0) | 0 (0) | - |
Per protocol | 0 (0) | 0 (0) | - |
Maternal death, n (%) | |||
ITT | 0 (0) | 0 (0) | - |
Per protocol | 0 (0) | 0 (0) | - |
Nonsevere side effects | |||
Nausea/vomiting, n (%) | |||
ITT | 12 (15) | 1 (2) | 0.002 |
Per protocol | 11 (15) | 1 (2) | 0.002 |
Phosphenes, n (%) | |||
ITT | 9 (12) | 2 (3) | 0.02 |
Per protocol | 8 (11) | 2 (3) | 0.02 |
Dizziness, n (%) | |||
ITT | 4 (5) | 3 (4) | 0.28 |
Per protocol | 4 (6) | 3 (4) | 0.28 |
Total nonsevere adverse effects, n (%) | |||
ITT | 18 (23) | 4 (6) | 0.03 |
Per protocol | 17 (24) | 4 (6) | 0.03 |