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Table 2 Outcomes 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)

 

D-dimer (ng/mL) 0-h

363 (307-420)

311 (257-365)

0.038*

D-dimer (ng/mL) 4-h

416 (376-455)

283 (254-312)

 

D-dimer (ng/mL) 24-ha

621 (563-679)

489 (437-540)

 

Chest tube bleeding (cc) 0 h

136 (109-163)

109 (89-129)

0.014†

Chest tube bleeding (cc) 4 h

366 (282-449)

263 (222-304)

 

Chest tube bleeding (cc) 24 hb

826 (704-949)

671 (549-793)

 

Chest tube total bleeding (cc)

1198 (1017-1380)

978 (809-1147)

 

Transfused patients at 24 h (%)

22 (27.8)

19 (23.8)

0.55

Inflammatory response (%)

15 (18.8)

6 (7.5)

0.03

Temperature > 38 (°C) n(%)

15(18.8)

6(7.5)

0.03

Cardiac index > 3.5 (L/min/m2) n(%)

65(82.3)

58(75.3)

0.29

Systemic vascular resistance index <1600 (dyne · sec/cm5 per m2) n(%)

31(39.2)

21(27.6)

0.13

Interleukine-6 (pg/mL) 0-h

281 (139-423)

239 (177-302)

0.79‡

Interleukine-6 (pg/mL) 4-h

511 (341-679)

470 (327-613)

 

Creatine kinase (U/L) 0 h

257 (207-352)

208 (160-315)

0.12¶

Creatine kinase (U/L) 4 h

336 (253-460)

281 (228-414)

 

Creatine kinase (U/L) 24 h

447 (336-807)

399 (266-657)

 

Creatine kinase peak (U/L)

487 (359-812)

407 (259-671)

0.01

Troponin I (ng/mL) 0 h

1.3 (1-2.8)

1.2 (0.6-1.7)

0.88**

Troponin I (ng/mL) 4 h

3.4 (2.4-5.3)

2.3 (1.6-3.9)

 

Troponin I (ng/mL) 24 h

1.8 (1.2-3.3)

1.6 (1.1-3.3)

 

Troponin I peak (ng/mL)

3.6 (2.7-6.3)

2.6 (1.7-4.7)

<0.01

Norepinephrine (mcg/Kg/min) 0 h

0.07(0.03-0.12)

0.06(0.02-0.10)

0.46††

Norepinephrine (mcg/Kg/min) 4 h

0.12(0.04-0.19)

0.09(0.03-0.14)

 

Norepinephrine (mcg/Kg/min) 24 h

0.20(0.05-0.35)

0.06(0.03-0.09)

 

Dobutamine (mcg/Kg/min) 0 h

1.77(1.03-2.51)

1.68(0.99-2.38)

0.96‡‡

Dobutamine (mcg/Kg/min) 4 h

1.60(0.80-2.41)

1.69(0.94-2.44)

 

Dobutamine (mcg/Kg/min) 24 h

1.19(0.47-1.92)

1.28(0.59-1.98)

 

Mechanical ventilation (h)d

7 (5-13)

7 (6-15)

0.60

Re-intervention, n (%)

5 (6.3)

2 (2.5)

0.44

Postoperative stroke, n (%)

1 (1.3)

2 (2.5)

0.56

Seizures, n (%)

0 (0)

2 (2.5)

0.49

Renal dysfunction, n (%)

6 (7.5)

7 (8.9)

0.75

Renal failure, n (%)

4 (5)

3 (3.8)

0.70

Myocardial infarction, n (%)

2 (2.5)

1 (1.3)

0.56

Intensive care length of stay (days)c

3 (2-5)

3 (2-5)

0.26

Mortality, n (%)

3 (3.8)

6 (7.6)

0.29

Composite Adverse Effects(%)

14(17.5)

11(13.8)

0.51

  1. Values expressed as means and 95% confidence interval; frequencies and percentages.
  2. aD-dimer levels at 24 hours (P = 0.01, corrected P significant). b Chest bleeding at 24 hours (P = 0.01, corrected P significant). cNorepinephrine at 24 h adjusted for dobutamine at 24 h (P = 0.014, corrected P significant). dValues expressed as median and interquartile range
  3. * † ‡ ¶ ** †† ‡‡ P values correspond to omnibus F-scores and were obtained using Mixed ANOVA
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Journal of Cardiothoracic Surgery

ISSN: 1749-8090

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