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Table 3 Assessment of PPH-related outcomea

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  
Evolution to severe PPH, n (%)    
   ITT 27 (35) 37 (50) 0.07
   Per protocol 23 (32) 36 (50) 0.028
Persistent bleeding at T2, n (%)    
   ITT 28 (36) 40 (54) 0.03
   Per protocol 26 (36) 38 (53) 0.044
Haemoglobin drop >4 g/dL, n (%)    
   ITT 19 (25) 32 (43) 0.02
   Per protocol 15 (21) 34 (47) < 0.001
PRBC transfusion before T4, n (%)    
   ITT 10 (13) 13 (18) 0.17
   Per protocol 7 (10) 12 (17) 0.65
PRBC units administered before T4, n    
   ITT 32 62 0.26
   Per protocol 18 38 0.4
PRBC transfusion total through day 42, n (%)    
   ITT 13 (17) 20 (27) 0.33
   Per protocol 9 (13) 20 (28) 0.16
PRBC units administered total through day 42, n    
   ITT 28 62 < 0.001
   Per protocol 24 62 < 0.001
Arterial embolisation, n (%)    
   ITT 5 (6.8) 5.1 (6.1) 1
   Per protocol 4 (6.0) 5 (7.0) 0.73
Surgical arterial ligature or hysterectomy, n (%)    
   ITT 0 2 (2.7) 0.24
   Per protocol 0 2 (3.0) 0.5
Late postpartum curettage (after day 7), n (%)    
   ITT 1 (1.3) 2 (2.7) 1
   Per protocol 1 (1.4) 2 (2.8) 1
Any vasopressor, n (%)    
   ITT 4 (5.2) 4 (5.4) 1
   Per protocol 3 (4.2) 4 (5.5) 1
Intensive care unit stay, n (%)    
   ITT 3 (3.9) 5 (6.7) 1
   Per protocol 3 (4.2) 5 (7.0) 1
Mild dyspnea, n (%)    
   ITT 0 (0) 1 (1.3) 1
   Per protocol 0 (0) 1 (1.4) 1
Multiple organ failure, n (%)    
   ITT 0 (0) 0 (0) -
   Per protocol 0 (0) 0 (0) -
  1. aPPH, postpartum haemorrhage; TA, tranexamic acid; ITT, intention to treat; PRBC, packed red blood cell. 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.