E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing elective coronary artery bypass grafting |
Elektiiviseen sepelvaltimo-ohitusleikkaukseen tulevia potilaita |
|
E.1.1.1 | Medical condition in easily understood language |
Patients undergoing elective coronary artery bypass grafting |
Elektiiviseen sepelvaltimo-ohitusleikkaukseen tulevia potilait |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068176 |
E.1.2 | Term | Coronary artery bypass graft |
E.1.2 | System Organ Class | 100000004865 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Comparison of the effect of two heparin doses (300 IU/kg vs. 600 IU/kg) on perioperative bleeding |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The first 60 patients: POC measurements (TEM and MEA) |
|
E.3 | Principal inclusion criteria |
elective coronary artery bypass grafting |
elektiiviseen sepelvaltimo-ohitusleikkaukseen tuleva potilas |
|
E.4 | Principal 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 |
preoperatiivinen pienimolekylaarinen hepariinihoito tai klopidogreelihoito; munuaisten vajaatoiminta (naisilla krea Z 135 umol/l ja miehillä > 150 umol/l) |
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E.5 End points |
E.5.1 | Primary end point(s) |
perioperative bleeding intraoperatively and ad 18 hours postoperatively |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The last patient followed ad 18 hours postoperatively |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 9 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |