Heparin dose (300 IU/kg vs. 600 IU/kg) in coroanry artery bypass grafting

Phase 1

• Conditions: Patients undergoing elective coronary artery bypass grafting; MedDRA version: 21.1 Level: LLT Classification code 10068176 Term: Coronary artery bypass graft System Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2012-000449-11-FI
• Lead Sponsor: Eero Pesonen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-06
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

elective coronary artery bypass grafting
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

*urgent operation
*reoperation
*concomitant cardiac surgery in addition to CABG
*antithrombotic or anticoagulant medication other than aspirin
*biological disease-modifying anti-inflammatory drugs
*per oral glucocorticoids
*LVEF < 30%
*eGFR < 50 ml/min
*laboratory values: hemoglobin < 120 g/l; platelet count <130 x10^9/l; INR > 1.2; CRP > 20 mg/l

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<br> Secondary Objective: Comparison of the effect of two heparin doses (300 IU/kg vs. 600 IU/kg) on<br> *consumption of blood products ( packed red blood cells, thrombocytes, fresh frozen plasma)<br> *perioperative myocardial injury<br> *laboratory parameters of coagulation, platelet function and inflammation<br> ;Main Objective: Comparison of the effect of two heparin doses (300 IU/kg vs. 600 IU/kg) on perioperative bleeding;Primary end point(s): perioperative bleeding intraoperatively and ad 18 hours postoperatively;Timepoint(s) of evaluation of this end point: indicated above

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): *consumption of blood products ( packed red blood cells, thrombocytes, fresh frozen plasma) intraoperatively and ad 18 hours postoperatively<br> *perioperative myocardial injury (creatinine kinase MB-fraction on the first postoperative morning)<br> *laboratory parameters of coagulation (including TEM at time-points 1, 4-6), platelet function (including MEA at time-points 1, 4-6 and inflammation in blood samples at 6 time-points: 1) preoperatively; 2) 20 min on CPB; 3) before aortic declamping; 4) 10 min after aortic declamping; 5) 30 min after protamine administration; 6) 3 hours after protamine administration<br> ;Timepoint(s) of evaluation of this end point: indicated above