Tranexamic Acid, Hemorrhage and Transfusions After 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 4 Study of Tranexamic Acid for Elderly Patients Undergoing Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.|
- Transfusion of blood components [ Time Frame: Intraoperatively and during postoperative stay ] [ Designated as safety issue: No ]
- Postoperative hemorrhage [ Time Frame: First 16 hours postoperatively ] [ Designated as safety issue: No ]
- Fibrinolysis [ Time Frame: 20 hours postoperatively ] [ Designated as safety issue: No ]
- Platelet activation [ Time Frame: 20 hours postoperatively ] [ Designated as safety issue: No ]
- Activation of coagulation [ Time Frame: 20 hours postoperatively ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Experimental: Tranexamic Acid||
Drug: Tranexamic acid
Tranexamic acid 10 mg/kg as a bolus dose followed by an infusion of 1 mg/kg/hour. Bolus given before start of surgery, infusion continued during surgery.
Other Name: Cykokapron ACT: B02A A02
|Placebo Comparator: placebo||
0.9% sodium chloride 10 mg/kg, as a bolus injection before surgery followed by 1 mg/kg/h as an infusion during surgery
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375466
|St. Olav University Hospital|
|Trondheim, Norway, 7006|
|Study Chair:||Hilde Pleym, MD, PhD||St. Olavs Hospital|
|Principal Investigator:||Guri Greiff, MD||St. Olavs Hospital|
|Principal Investigator:||Alexander Wahba, MD, PhD||St. Olavs Hospital|
|Principal Investigator:||Roar Stenseth, MD, PhD||St. Olavs Hospital|