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Sponsored by: |
Hopital Foch |
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Information provided by: | Hopital Foch |
ClinicalTrials.gov Identifier: | NCT00809393 |
Cardiac surgery with CardioPulmonary Bypass (CPB) exposes to per and postoperative bleeding, and may lead to allogenic blood transfusion re-intervention and many adverse outcomes. Prophylactic use of tranexamic Acid (TA) has been shown to decrease blood loss and blood transfusion during cardiac surgery.There currently are multiple dosing regimens for TA for cardiac surgery.Preliminary dose-response study has shown that low prophylactic dose of TA would be as accurate for haemostatic efficacy as higher dose. The primary objective of this tri-center, prospective, double-blinded, randomised trial is to compare two administrations and dosing regimens of TA during cardiac surgery with CPB on the perioperative blood loss Patients are divided in two groups: low and high risk surgery. Methods: After written informed consent, patients are randomly assigned to one of the two treatment groups. The low dose TA group is: 10 mg/kg TA given over 15 min, followed by an infusion of 1 mg/kg/h throughout the operation, and 1 mg/kg into the CPB prime volume. The high dose group is :30 mg/kg TA given over 15 min, followed by an infusion of 16 mg/kg/h throughout the operation, and 2 mg/kg into the CPB prime volume. Hemodynamic and anaesthesia care will be as usual. A blood salvage device will be systematically used. The triggers for transfusion will be: red blood cells: haemoglobin less than 8 g/dl or 6 g/dl during CBP; Plasma: PT less than 50% or INR more than 1.5; platelets: platelets count less than 50/70 G/mm3; fibrinogen: fibrinogen less than 1g/l . All patients will receive standard anaesthesia and perioperative care.
Patients will be stratified in two groups for the statistical analysis; low and high risk surgery. Analysis will be in intention to treat. 300 patients should be recruited in each group to detect an absolute difference of respectively 10% (low risk cardiac surgery) and 20% (high risk cardiac surgery) in the number of patients exposed to allogenic blood transfusion between patients receiving high dose TA regimen and those receiving low dose TA regimen, assuming a power of 80% and a two-tailed value less than 0.05.
Condition | Intervention | Phase |
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Cardiopulmonary Bypass Hemorrhage |
Drug: tranexamic acid |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Two Tranexamic Acid Dose Regimens on Transfusion Needs During Cardiac Surgery With Cardiopulmonary Bypass |
Estimated Enrollment: | 600 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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low dose: Active Comparator
low dose tranexamic acid
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Drug: tranexamic acid
10 mg/kg
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high dose: Experimental |
Drug: tranexamic acid
30 mg/kg
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marc Fischler, MD | 0033146252442 | m.fischler@hopital-foch.org |
France | |
department of anesthesiology, Bichat Hospital | Not yet recruiting |
Paris, France, 75018 | |
Contact: Dan Longrois, MD | |
Sub-Investigator: Dan Longrois, MD | |
department of anesthesiology, Haut Leveque Hospital | Recruiting |
Bordeaux, France | |
Contact: Jean-Christophe Marty, MD | |
Sub-Investigator: Jean-christophe Marty, MD |
Principal Investigator: | Marc Fischler, MD | Hopital Foch |
Responsible Party: | Hopital Foch ( Pr marc Fischler ) |
Study ID Numbers: | 2008/27 |
Study First Received: | December 15, 2008 |
Last Updated: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00809393 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Antifibrinolytic Tranexamic acid Cardiopulmonary bypass Transfusion Hemorrhage |
Fibrin Modulating Agents Antiplasmin Antifibrinolytic Agents |
Tranexamic Acid Hemorrhage Hemostatics |
Fibrin Modulating Agents Antifibrinolytic Agents Pathologic Processes Coagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Tranexamic Acid Hemorrhage Hemostatics Pharmacologic Actions |