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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000449-11-FI

Enrollment

200

Registered

2012-02-06

Start date

2012-03-01

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Heparin LEO 5000 IE/KY/ml injektioneste Product Name: Heparin LEO 5000 IE/KY/ml Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 1.2; CRP > 20 mg/l

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): consumption of blood products ( packed red blood cells, thrombocytes, fresh frozen plasma) intraoperatively and ad 18 hours postoperatively perioperative myocardial injury (creatinine kinase MB-fraction on the first postoperative morning) *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;Timepoint(s) of evaluation of this end point: indicated above	—

Measure

Time frame

Secondary end point(s): *consumption of blood products ( packed red blood cells, thrombocytes, fresh frozen plasma) intraoperatively and ad 18 hours postoperatively *perioperative myocardial injury (creatinine kinase MB-fraction on the first postoperative morning) *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;Timepoint(s) of evaluation of this end point: indicated above

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026