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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