A randomised control clinical study to determine whether SNBTS Fibrin Sealant promotes wound healing in patients undergoing cardiac surgery. - SNBTS FS rand study to promote wound healing in cardiac surgery

Committee of Management, Common Services Agency T/A Scottish National Blood Transfusion Service0 sites400 target enrollmentFebruary 23, 2005

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: In patients undergoing cardiac surgery the saphenous leg vein is used to replace veins used in coronary artery bypass grafts (CABG) surgery.
Sponsor: Committee of Management, Common Services Agency T/A Scottish National Blood Transfusion Service
Enrollment: 400
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

February 23, 2005

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Committee of Management, Common Services Agency T/A Scottish National Blood Transfusion Service

•Patients undergoing elective coronary artery bypass graft surgery (CABG) or CABG plus any other procedure which uses the saphenous vein in the leg as a donor site.
•Patients over 16 year of age.
•Patients who have given written informed consent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•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

•Female patients of a child bearing age who are pregnant or not taking adequate contraception.
•Patients witha known history of adverse reactions to plasma products.
•Patients under 16 years of age.
•Patients enrolled on another clinical study in the last 6 months involving study medication with the potential to interact with Fibrin Sealant.
•Patients requiring emergency cardiac surgery.
•Patients taking Warfarin or any other anti\-coagulants a day before surgery (although current hospital policy is to stop anti\-coagulant therapy seven days before elective cardiac surgery). This will be checked by performing an INR test within 24 hours before surgery. Any patient with INR\>1\.5 will not be randomised into the study.