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 个研究点目标入组 400 人开始时间: 2005年2月23日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•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.

发起方

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