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Table 1 Baseline characteristics of treatment groups.

From: Safety and Effectiveness of two treatment regimes with tranexamic acid to minimize inflammatory response in elective cardiopulmonary bypass patients: a randomized double-blind, dose-dependent, phase IV clinical trial

 

Tranexamic acid

P

 

TA1 group

(40-0 mg/Kg)

(n = 80)

TA2 group

40-40 mg/Kg

(n = 80)

 

Demographics

   

Age (years)

65 (62-69)

68 (65-70)

0.24

Male sex, n (%)

54 (67.5)

49 (61.3)

0.41

Parsonnet

9.2 (7.2-11.2)

10.5 (8.4-12.5)

0.30

Euroscorea

4 (3-6)

4 (3-7)

0.38

Logistic Euroscorea

3.25(1.83-5.53)

3.27(1.75-6.68)

0.84

Body mass index (Kg/m2)

28.2 (27.4-29)

27.7 (26.6-28.8)

0.50

Comorbidity

   

Hypertension, n (%)

43 (53.8)

53 (66.3)

0.11

Diabetes, n (%)

36 (45)

28 (35)

0.42

Medical treatment

   

Angiotensin-converting enzyme inhibitors, n (%)

28 (35)

22 (27.5)

0.31

Preoperative parameters

   

Platelet count (× 103 ml-1)

247 (227-267)

262 (239-285)

0.48

D-dimer (ng/ml)

347 (217-476)

287 (221-353)

0.95

International normalized ratio

1.04 (1-1.07)

1.05 (1.01-1.09)

0.28

Cardiac intervention

   

Coronary, n (%)

45 (56.3)

39 (48.8)

0.51

Valvular, n (%)

25 (31.3)

31 (38.8)

 

Both, n (%)

9 (11.3)

7 (8.8)

 

Other, n (%)b

1 (1.3)

3 (3.8)

 

Second intervention, n (%)

4 (5)

3 (3.8)

0.51

Surgical data

   

Temperature during cardiopulmonary bypass (°C)

32.3 (32-32.5)

32.3 (32.1-32.5)

0.78

Aortic clamp time (min)

53 (49-58)

51 (46-57)

0.61

Cardiopulmonary bypass time(min)

88 (82-94)

84 (77-92)

0.45

Temperature after cardiopulmonary bypass (°C)

35.5 (35.3-35.6)

35.7 (35.5-35.8)

0.03

Total heparin dose (UI/Kg)

391 (371-412)

400 (379-421)

0.56

Total protamine dose (mg/Kg)

2.7 (2.6-2.8)

2.9 (2.8-3.1)

0.04

Heparine/protamine

1.45 (1.37-1.53)

1.39 (1.33-1.44)

0.29

Blood salvage (ml)

724 (663-784)

703 (636-767)

0.64

  1. Values expressed as mean and 95% confidence interval; frequencies and percentages; amedian and percentiles.
  2. bInter-atrial communication.