Hemorrhage Clinical Trial
Official title:
Phase 4 Study of Tranexamic Acid for Elderly Patients Undergoing Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.
In this study we will investigate whether tranexamic acid given as an intravenous bolus
injection before start of surgery, followed by a continuous infusion during surgery reduces,
perioperative hemostatic activation, and postoperative bleeding and the need for
transfusions of blood components in elderly patients undergoing combined aortic valve
replacement and coronary artery bypass surgery. Tranexamic acid will be compared with
placebo (0.9% sodium chloride) in a randomized and double-blind study design.
The study hypothesis is that tranexamic acid will reduce hemostatic activation and
postoperative hemorrhage and the need for blood component transfusions in this group of
patients.
Status | Completed |
Enrollment | 63 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria: Patients above 70 years of age scheduled for combined aortic valve
replacement and coronary artery bypass surgery. Exclusion Criteria: Patients younger than 70 years of age. Patients scheduled for other procedures than combined aortic valve replacement and coronary artery bypass surgery. Patients who are not treated with aspirin. Patients with a medical condition known to influence the hemostatic system. Patients treated with drugs other than aspirin during the last week before surgery that may influence the hemostatic system, such as warfarin (coumarin), non-steroidal antiinflammatory drugs, clopidogrel, heparin, low molecular heparins. Patients who are treated with systemic steroids. Patients with a serum creatinin concentration above 140 micromol/l. Patients with an INR above 1.5. Patients who are not able to give written informed concent. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | St. Olav University Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
St. Olavs Hospital |
Norway,
Greiff G, Stenseth R, Wahba A, Videm V, Lydersen S, Irgens W, Bjella L, Pleym H. Tranexamic acid reduces blood transfusions in elderly patients undergoing combined aortic valve and coronary artery bypass graft surgery: a randomized controlled trial. J Car — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transfusion of blood components | Intraoperatively and during postoperative stay | No | |
Secondary | Postoperative hemorrhage | First 16 hours postoperatively | No | |
Secondary | Fibrinolysis | 20 hours postoperatively | No | |
Secondary | Platelet activation | 20 hours postoperatively | No | |
Secondary | Activation of coagulation | 20 hours postoperatively | No |
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