The use of clopidogrel and aprotonin in off pump coronary artery bypass grafting

Phase 1

• Conditions: Bleeding after coronary artery bypass grafting; MedDRA version: 9.1 Level: LLT Classification code 10005645 Term: Blood loss of (NOS)

• Registration Number: EUCTR2007-002652-42-GB
• Lead Sponsor: Royal Brompton and Harefield NHS Trsut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-26
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 270

Inclusion Criteria

Informed consent
Scheduled for OPCAB surgery
Currently taking clopidogrel 75mg/day

Are the trial subjects under 18? no
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

Exclusion Criteria

Emergency procedures
Pre existing coagulation abnormalities
Warfarin therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: •To investigate whether clopidogrel administration peri operatively affects peri operative blood loss in off pump cardiac surgery.<br><br> ;<br> Secondary Objective: •To investigate if aprotonin administration to patients receiving clopidogrel in off pump cardiac surgery reduces peri operative blood loss.<br><br> •To determine if the degree of platelet inhibition as demonstrated by the modified thromboelastography (TEG) correlates with blood loss in off pump cardiac surgery.<br><br> ;<br> Primary end point(s): Blood loss (intraoperatively into suction and post operative chest drain losses)<br><br>