Coronary Bypass Grafting With Minimal Extracorporeal Circulation System Versus Off-pump Coronary Surgery

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Off-pump coronary artery bypass graft; Procedure: Mini extracorporeal circulation bypass

• Registration Number: NCT02118025
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

The investigators aimed to evaluate the clinical results and the inflammatory response of the minimal extracorporeal circulation system (MECC) Compared with off-pump coronary revascularization (OPCABG).

This is a randomized and prospective study in 230 patients with indications for coronary surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were the clinical and biochemical results, intra-operative outcomes and the determination of 19 inflammatory circulating markers, 17 of them for the first time analyzed comparing both techniques.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-11
• Study Completion: 2013-06
• Status Verified: 2014-03
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-04-16
• Last Update Submitted: 2014-04-16
• Study First Posted: 2014-04-21
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Indication for coronary surgery established on the basis of current published guidelines

Exclusion Criteria

• Documented preoperative systemic proinflammatory status and/or steroid administration within 6 months before surgery.
• Coexistence of a cardiomyopathy different than coronary artery disease that precise surgical treatment.
• Left ventricle ejection fraction of 40% or less.
• Treatment with erythropoietin (EPO) three months before the intervention
• Hematocrit less than 35% the day prior to the procedure
• Redo surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Off-pump coronary artery bypass graft	Off-pump coronary artery bypass graft	Patients operated on with off-pump coronary artery bypass graft, beating heart surgery.
Mini extracorporeal circulation bypass	Mini extracorporeal circulation bypass	Patients operated on with mini extracorporeal circulation bypass. A modified extracorporeal system.

Primary Outcome Measures

Name	Time	Method
Clinical outcomes	within the first 30 days (plus or minus 3 days) after surgery	Number of Participants with Adverse Events, e.g, renal failure, atrial fibrillation, acute myocardial infarct, stroke, redo surgery, death.

Secondary Outcome Measures

Name	Time	Method
Determination of increase over the first 48 hours of plasma levels of 19 circulating markers of inflammatory response.	Area Under the Concentration-Time Curve (AUC 0-48 hours)	Determination of increase over the first 48 hours after the operation of plasma levels of 19 circulating markers of inflammatory response. The levels of inflammatory markers are measured in pg / mL and subsequently, the increase over the 48 hours is determined with the area under the curve.
Biochemical outcomes	Within the first 30 days (plus or minus 3 days) after surgery	Changes in creatine kinase levels, troponin levels, glucose, leukocytes, platelets, hemoglobin and hematocrit levels. From basal point to 48 hours time after surgery.
Operative results	Within the first 30 days (plus or minus 3 days) after surgery	Total hospitalization time (days)

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain