Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.
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|ClinicalTrials.gov Identifier: NCT00375466|
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : December 13, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhage||Drug: Tranexamic acid Drug: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 4 Study of Tranexamic Acid for Elderly Patients Undergoing Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
|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
- Transfusion of blood components [ Time Frame: Intraoperatively and during postoperative stay ]
- Postoperative hemorrhage [ Time Frame: First 16 hours postoperatively ]
- Fibrinolysis [ Time Frame: 20 hours postoperatively ]
- Platelet activation [ Time Frame: 20 hours postoperatively ]
- Activation of coagulation [ Time Frame: 20 hours postoperatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|