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Table 4 Side effects of treatmenta

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
  1. aTA, tranexamic acid; ITT, intention to treat. α risk: P < 0.05 using the χ2 test or Fisher's exact test for categorical variables. Student's t-test was used in cases of normal distribution, and otherwise the Mann-Whitney U test was used for numerical variables.