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Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.

NCT00375466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2012-12-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

DRUG

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

Sponsors & Collaborators

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Hilde Pleym, MD, PhD · St. Olavs Hospital

  • Guri Greiff, MD · St. Olavs Hospital

  • Alexander Wahba, MD, PhD · St. Olavs Hospital

  • Roar Stenseth, MD, PhD · St. Olavs Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Norway

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00375466 on ClinicalTrials.gov