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Tranexamic acid to elderly patients undergoing combined AVR and CABG surgery.

Conditions
We will investigate whether tranexamic acid given as a bolus injection at the start of surgery followed by a continuous infusion during surgery reduces postoperative bleeding in patients above 70 years undergoing combined AVR and CABG surgery.
Registration Number
EUCTR2006-004561-34-NO
Lead Sponsor
St. Olavs Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

|Female and male patients above 70 years who are scheduled for combined AVR and CABG surgery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients below 70 years.
Patients undergoing other cardiac surgery than combined AVR and CABG surgery.
Patients who are not pretreated with acetylsalicylic acid.
Patients with known defects in the hemostatic system.
Patients pretreated with NSAIDs, clopidogrel, heparin, LMWHs, or warfarin.
Patients treated with systemic steroids.
Patients with a creatinine level above 140 micromol/l.
Patients with an INR above 1.5.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: Investigate whether tranexamic acid given intraoperatively reduces postoperativ bleeding and the use of blood components after cardiac surgery.;Secondary Objective: Invetsigate whether tranexamic acid reduces fibrinolysis during and after cardiac surgery.;Primary end point(s): Postoperative bleeding, postoiperative loss of hemoglobin, postoperative use of blood components after cardiac surgery.
Secondary Outcome Measures
NameTimeMethod
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