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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.