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Rationale:
Contemporary coronary artery bypass grafting (CABG) continues to be associated with a significant risk of postoperative bleeding. Utilization of miniaturized extracorporeal circulation (miECC) significantly reduces the risk of postoperative bleeding but the underlying mechanisms are poorly understood.
Primary Objective:
To assess the impact of miECC compared to conventional extracorporeal circulation (cECC) on thrombin generation as indicator of the overall haemostatic capacity after CABG.
Secondary Objectives To evaluate the impact of miECC versus cECC on blood loss and transfusion requirement, coagulation and fbrinolysis, inflammatory response, haemodilution and haemolysis, endorgan protection, seasibility and safety
Study design:
Single-center, double-blind, parallel-group randomized controlled trial
Study population:
60 Patients undergoing non-emergent primary isolated CABG with ECC randomized 1:1 to receive either miECC or cECC
Blood samples will be obtained at the following time points:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CABG with miniaturized ECC | Active Comparator | Elective (CABG) with conventional miniaturized extracorporeal circulation (miECC) |
|
| CABG with conventional ECC | Active Comparator | Elective CABG with conventional extracorporeal circulation (cECC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CABG | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative thrombin generation | Thrombin generation as a measure of the ability to generate thrombin in platelet poor plasma. Derived from the thrombogram | up to 6 hours after CABG |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative blood loss | Total output of mediastinal and pleural chest tubes | up to 24 hours after CABG |
| Postoperative transfusion requirement | Transfusion of red blood cells, fresh frozen plasma, platelets |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivy Susanne Modrau, MD | Dep. of Cardiothoracic Surgery, Aarhus University Hospital Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Cardiothoracic Surgery, Aarhus University Hospital | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38961388 | Derived | Halle DR, Benhassen LL, Soberg KL, Nielsen PF, Kimose HH, Bauer A, Hasenkam JM, Modrau IS. Impact of minimal invasive extracorporeal circulation on systemic inflammatory response - a randomized trial. J Cardiothorac Surg. 2024 Jul 3;19(1):418. doi: 10.1186/s13019-024-02903-8. | |
| 32011717 | Derived | Modrau IS, Halle DR, Nielsen PH, Kimose HH, Greisen JR, Kremke M, Hvas AM. Impact of minimally invasive extracorporeal circulation on coagulation-a randomized trial. Eur J Cardiothorac Surg. 2020 Jun 1;57(6):1145-1153. doi: 10.1093/ejcts/ezaa010. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2017 | Sep 26, 2017 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Miniaturized extracorporeal circulation | Procedure |
|
|
| Conventional extracorporeal circulation | Procedure |
|
|
| up to 30 days after CABG |
| Fibrinolysis (Clot lysis, Fibrin D-dimer) | Clot lysis measured by dynamic turbidimetry | up to 24 hours after CABG |
| Coagulation tests |
| up to 24 hours after CABG |
| Inflammatory response |
| up to 24 hours after CABG |
| Haemodilution (Nadir intraoperative haematocrit) | Measured in arterial blood samples | up to 24 hours after CABG |
| Haemolysis (LDH) | Measured in lithium heparin plasma | up to 24 hours postoperative |
| Postoperative CK-MB for myocardial injury | Measured in lithium heparin plasma | up to 24 hours after CABG |
| -Intraoperative blood lactate for inadequate tissue perfusion | Measured in arterial blood samples | up to 24 hours after CABG |
| Postoperative creatinine clearance for renal injury | Creatinine measured in lithium heparin plasma. eGFR calculated according to the CKD EPI Equation for Estimating GFR Expressed for Specified Race, Sex and Serum Creatinine (µmol/L) | up to 30 days after CABG |
| -Perioperative myocardial infarction | defined according to the new definition of clinically relevant MI of the Society for Cardiovascular Angiography and Interventions | 48 hours after CABG |
| -In-hospital neurological events (TCI/stroke) | verified by CT or MRI | up to 30 days after CABG |
| -Postoperative requirement of renal replacement therapy | Continuous or intermittend renal replacement therapy | up to 30 days after CABG |
| -Postoperative re-exploration for bleeding | Re-exploration due to excessive bleeding or haemodynamic instability | up to 30 days after CABG |
| -Repeat revascularization | Defined as unplanned repeat PCI or CABG | up to 30 days after CABG |
| -Length of ICU stay | Days of stay on ICU | up to 30 days after CABG |
| -Duration of inotropic support | Hours of pharmacological or mechanical circulatory support | up to 30 days after CABG |
| -Incidence of atrial fibrillation | Documented by telemetry or ECG | up to 30 days after CABG |
| -Incidence of infection (requiring antibiotic therapy, wound revision for graft leg infection, superficial or deep sternal wound infection) |
| up to 30 days after CABG |
| -Feasibility of miECC as measured by conversion to cECC and intraoperative complications | Serious adverse device events (air lock, dissection, bleeding that exceeds the capacity of the cell saver, air emboli, stop of the circuit, conversion to cECC) - technical aspects (postoperative fluid gain (ml), venous drainage, visibility due to blood in the operative field, ability to maintain SvO2 >65%) | 24 hours |
| -30-day MACCE |
| up to 30 days after CABG |
| Acute kidney injury | Association of AKI with Neutrophil gelatinase associated lipocalin (NGAL) and renal risistive index (RRI) | up to 7 days after intervention |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |