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Randomized Controlled Trial
. 2007;11(6):R117.
doi: 10.1186/cc6173.

Tranexamic acid attenuates inflammatory response in cardiopulmonary bypass surgery through blockade of fibrinolysis: a case control study followed by a randomized double-blind controlled trial

Juan J Jimenez  1 , Jose L Iribarren, Leonardo Lorente, Jose M Rodriguez, Domingo Hernandez, Ibrahim Nassar, Rosalia Perez, Maitane Brouard, Antonio Milena, Rafael Martinez, Maria L Mora
Affiliations
Randomized Controlled Trial

Tranexamic acid attenuates inflammatory response in cardiopulmonary bypass surgery through blockade of fibrinolysis: a case control study followed by a randomized double-blind controlled trial

Juan J Jimenez et al. Crit Care. 2007.

Abstract

Introduction: Extracorporeal circulation induces hemostatic alterations that lead to inflammatory response (IR) and postoperative bleeding. Tranexamic acid (TA) reduces fibrinolysis and blood loss after cardiopulmonary bypass (CPB). However, its effects on IR and vasoplegic shock (VS) are not well known and elucidating these effects was the main objective of this study.

Methods: A case control study was carried out to determine factors associated with IR after CPB. Patients undergoing elective CPB surgery were randomly assigned to receive 2 g of TA or placebo (0.9% saline) before and after intervention. We performed an intention-to-treat analysis, comparing the incidence of IR and VS. We also analyzed several biological parameters related to inflammation, coagulation, and fibrinolysis systems. We used SPSS version 12.2 for statistical purposes.

Results: In the case control study, 165 patients were studied, 20.6% fulfilled IR criteria, and the use of TA proved to be an independent protective variable (odds ratio 0.38, 95% confidence interval 0.18 to 0.81; P < 0.01). The clinical trial was interrupted. Fifty patients were randomly assigned to receive TA (24) or placebo (26). Incidence of IR was 17% in the TA group versus 42% in the placebo group (P = 0.047). In the TA group, we observed a significant reduction in the incidence of VS (P = 0.003), the use of norepinephrine (P = 0.029), and time on mechanical ventilation (P = 0.018). These patients showed significantly lower D-dimer, plasminogen activator inhibitor 1, and creatine-kinase levels and a trend toward lower levels of soluble tumor necrosis factor receptor and interleukin-6 within the first 24 hours after CPB.

Conclusion: The use of TA attenuates the development of IR and VS after CPB.

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Figures

Figure 1
Figure 1
Levels of interleukin-6 (IL-6) at 4 hours between inflammatory response (IR) patients and non-IR patients. ICU, intensive care unit.
Figure 2
Figure 2
Relationship between 24-hour chest tube bleeding and inflammatory response. Horizontal lines represent the median, boxes encompass the 25th to 75th percentile, and error bars encompass the 10th to 90th percentile.
Figure 3
Figure 3
Randomized control trial flow diagram.
Figure 4
Figure 4
Twenty-four-hour chest tube bleeding between tranexamic acid and placebo groups. Horizontal lines represent the median, boxes encompass the 25th to 75th percentile, and error bars encompass the 10th to 90th percentile.
Figure 5
Figure 5
Differences between tranexamic acid (TA) (solid line) and placebo (dotted line) in D-dimer levels. ICU, intensive care unit.
See this image and copyright information in PMC

Comment in

References

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