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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: Trade Name: Plavix Product Name: clopidogrel Pharmaceutical Form: Tablet CAS Number: 94188848 Other descriptive name: CLOPIDOGREL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75mg‐ Trade Name: Trasylol Product Name: aprotinin Pharmaceutical Form: Concentrate for solution for infusion Other descriptive name: APROTININ CONCENTRATED SOLUTION Concentration unit: KIU/ml kallikrein inactivator unit/millilitre Concentration type: equal Concentration number: 10 000‐ CONDITION: Bleeding after coronary artery bypass grafting ; MedDRA version: 9.1 Level: LLT Classification code 10005645 Term: Blood loss of (NOS) PRIMARY OUTCOME: Main Objective: • To investigate whether clopidogrel administration peri operatively affects peri operative blood loss in off pump cardiac surgery. ; ; Primary end point(s): Blood loss (intraoperatively into suction and post operative chest drain losses); ; Secondary Objective: • To investigate if aprotonin administration to patients receiving clopidogrel in off pump cardiac surgery reduces peri operative blood loss. ; ; • To determine if the degree of platelet inhibition as demonstrated by the modified thromboelastography (TEG) correlates with blood loss in off pump cardiac surgery.; ; 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
Epistemonikos ID: 1323746d198331006623c7280d8bb9cc1a5fb976
First added on: Aug 21, 2024