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Dose-Ranging Study of Two Doses of Tranexamic Acid During Cardiac Surgery (Exacylcardio)
This study is currently recruiting participants.
Verified by Hopital Foch, February 2009
First Received: December 15, 2008   Last Updated: February 24, 2009   History of Changes
Sponsored by: Hopital Foch
Information provided by: Hopital Foch
ClinicalTrials.gov Identifier: NCT00809393
  Purpose

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
Cardiopulmonary Bypass
Hemorrhage
Drug: tranexamic acid
Phase IV

MedlinePlus related topics: Anesthesia Blood Transfusion and Donation Heart Surgery Surgery
Drug Information available for: Tranexamic acid
U.S. FDA Resources
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

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • The primary study outcome is the number of patients in each group exposed to allogenic blood transfusion during the first 7 days after surgery. [ Time Frame: 7th day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of fresh plasma frozen units, platelets units needed for the 7 days , post operative blood loss in the 24 hours, needed or repeat surgery due to haemorrhage for the 24 hours following surgery, in-hospital death at 7 and 28 days. [ Time Frame: 28th day ] [ Designated as safety issue: No ]

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
low dose: Active Comparator
low dose tranexamic acid
Drug: tranexamic acid
10 mg/kg
high dose: Experimental Drug: tranexamic acid
30 mg/kg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any type of cardiac surgical procedure requiring CPB (including coronary artery bypass grafting, valve repair or replacement, aortic surgery, endocarditis).

Exclusion Criteria:

  • Emergency surgery, age < 18 years old, pregnancy, history of allergy to TA, history of seizure or thromboembolism event, history of previous antifibrinolytic or thrombolytic therapy within 5 days of surgery, coagulation disorder, liver disease, renal failure (clearance < 30 ml/min), Jehovah witness.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809393

Contacts
Contact: Marc Fischler, MD 0033146252442 m.fischler@hopital-foch.org

Locations
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            
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Marc Fischler, MD Hopital Foch
  More Information

No publications provided

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

Keywords provided by Hopital Foch:
Antifibrinolytic
Tranexamic acid
Cardiopulmonary bypass
Transfusion
Hemorrhage

Study placed in the following topic categories:
Fibrin Modulating Agents
Antiplasmin
Antifibrinolytic Agents
Tranexamic Acid
Hemorrhage
Hemostatics

Additional relevant MeSH terms:
Fibrin Modulating Agents
Antifibrinolytic Agents
Pathologic Processes
Coagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Tranexamic Acid
Hemorrhage
Hemostatics
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009