High-dose tranexamic acid reduces blood loss in postpartum haemorrhage

Table 3 Assessment of PPH-related outcome^a

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)	-

^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.

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