Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/361
Título : 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
Autor : Jiménez, Juan J.
Iribarren, José L.
Brouard, Maitane
Hernández, Domingo
Palmero, Salomé
Jiménez, Alejandro
Lorente, Leonardo
Machado, Patricia
Borreguero, Juan M.
Raya, José M
Martín, Beatriz
Pérez, Rosalía
Martínez, Rafael
Mora, María L.
Filiación: [Jimenez,JJ; Iribarren,JL; Brouard,M; Palmero,S; Lorente,L; Pérez,R; Mora,ML] Critical Care Department, Hospital Universitario de Canarias. [Hernández,D] Departamento de Nefrología, Hospital Universitario Carlos Haya, Málaga, España. [Jiménez,A] Mixed Research Unit, Hospital Universitario de Canarias. [Machado,P; Raya,JM] Hematology Laboratory, Hospital Universitario de Canarias. [Borreguero,JM; Martín,B] Biochemical laboratory. Hospital Universitario de Canarias. [Martínez,R] Cardiac Surgery Department. Hospital Universitario de Canarias.
Palabras clave : Cardiac surgery
Inflammatory response
Bleeding
MeSH: Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Surgical Procedures, Elective
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Extracorporeal Circulation::Cardiopulmonary Bypass
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Hematologic Agents::Coagulants::Hemostatics::Antifibrinolytic Agents
Medical Subject Headings::Phenomena and Processes::Circulatory and Respiratory Physiological Phenomena::Blood Physiological Phenomena::Blood Physiological Processes::Hemostasis::Blood Coagulation::Fibrinolysis
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Carboxylic Acids::Acids, Carbocyclic::Cyclohexanecarboxylic Acids::Tranexamic Acid
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome
Medical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Epidemiologic Research Design::Double-Blind Method
Fecha de publicación : 2011
Editorial : BioMed Central
Cita Bibliográfica: Jiménez JJ, Iribarren JL, Brouard M, Hernández D, Palmero S, Jiménez A, et al. 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. J Cardiothorac Surg. 2011;6:138.
Abstract: Background. In cardiopulmonary bypass (CPB) patients, fibrinolysis may enhance postoperative inflammatory response. We aimed to determine whether an additional postoperative dose of antifibrinolytic tranexamic acid (TA) reduced CPB-mediated inflammatory response (IR). Methods. We performed a randomized, double-blind, dose-dependent, parallel-groups study of elective CPB patients receiving TA. Patients were randomly assigned to either the single-dose group (40 mg/Kg TA before CPB and placebo after CPB) or the double-dose group (40 mg/Kg TA before and after CPB). Results. 160 patients were included, 80 in each group. The incident rate of IR was significantly lower in the double-dose-group TA2 (7.5% vs. 18.8% in the single-dose group TA1; P = 0.030). After adjusting for hypertension, total protamine dose and temperature after CPB, TA2 showed a lower risk of IR compared with TA1 [OR: 0.29 (95% CI: 0.10-0.83), (P = 0.013)]. Relative risk for IR was 2.5 for TA1 (95% CI: 1.02 to 6.12). The double-dose group had significantly lower chest tube bleeding at 24 hours [671 (95% CI 549-793 vs. 826 (95% CI 704-949) mL; P = 0.01 corrected-P significant] and lower D-dimer levels at 24 hours [489 (95% CI 437-540) vs. 621(95% CI: 563-679) ng/mL; P = 0.01 corrected-P significant]. TA2 required lower levels of norepinephrine at 24 h [0.06 (95% CI: 0.03-0.09) vs. 0.20(95 CI: 0.05-0.35) after adjusting for dobutamine [F = 6.6; P = 0.014 corrected-P significant]. We found a significant direct relationship between IL-6 and temperature (rho = 0.26; P < 0.01), D-dimer (rho = 0.24; P < 0.01), norepinephrine (rho = 0.33; P < 0.01), troponin I (rho = 0.37; P < 0.01), Creatine-Kinase (rho = 0.37; P < 0.01), Creatine Kinase-MB (rho = 0.33; P < 0.01) and lactic acid (rho = 0.46; P < 0.01) at ICU arrival. Two patients (1.3%) had seizure, 3 patients (1.9%) had stroke, 14 (8.8%) had acute kidney failure, 7 (4.4%) needed dialysis, 3 (1.9%) suffered myocardial infarction and 9 (5.6%) patients died. We found no significant differences between groups regarding these events. Conclusions. Prolonged inhibition of fibrinolysis, using an additional postoperative dose of tranexamic acid reduces inflammatory response and postoperative bleeding (but not transfusion requirements) in CPB patients. A question which remains unanswered is whether the dose used was ideal in terms of safety, but not in terms of effectiveness.
URI: http://hdl.handle.net/10668/361
Versión del editor : http://www.cardiothoracicsurgery.org/content/6/1/138
DOI: 10.1186/1749-8090-6-138
ISSN : 1749-8090 (Online)
Appears in Collections:01- Artículos - Hospital Regional de Málaga

Files in This Item:
File Description SizeFormat 
Hernandez_SafetyEffectiveness.pdfArtículo publicado578,05 kBAdobe PDFView/Open


This item is licensed under a Creative Commons License Creative Commons