Status:
COMPLETED
The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients
Lead Sponsor:
Amphia Hospital
Conditions:
Blood Loss
Tranexamic Acid
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
It remains still unclear whether topical tranexamic acid has an added value besides the administration of intravenously tranexamic acid. We hypothesize that the addition of topical tranexamic acid, be...
Eligibility Criteria
Inclusion
- Gender; male/ female
- Age: ≥ 18 year
- Elective cardiac surgical patients
- Coronary artery bypass graft (CABG) (conventional, E.CCO)
- Aortic valve replacement (AVR) (conventional)
- Mitral valve replacement (MVR)/ Mitral valve repairment (MPL) (conventional)
- Tricuspid valve replacement (TVR) / Tricuspid valve repairment (TPL)
- Bentall
- Combined procedure (e.g. CABG/ AVR, MVR/AVR, AVR/Maze)
Exclusion
- MVR/MPL (minimal invasive, Port Access Surgery)
- Maze (minimal invasive, via Thoracoscopy)
- AVR (minimal invasive, via mini Sternotomy)
- off-pump procedures
- Emergency operations
- Patient with increased or decreased blooding tendency (FV leiden, prot C, S deficiency, anti-thrombin deficiency, prothrombin mutation)
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT01895101
Start Date
October 1 2013
End Date
March 1 2015
Last Update
May 20 2015
Active Locations (1)
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1
Amphia Hospital
Breda, Netherlands, 4800 RK