Clinical trial NCT02118025: Coronary Bypass Grafting With Minimal Extracorporeal Circulation System Versus Off-pump Coronary Surgery
Official title: Prospective Randomized Comparison of Coronary Bypass Grafting With Minimal Extracorporeal Circulation System (MECC) Versus Off-pump Coronary Surgery. New Insights Into Inflammatory Cytokines.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Off-pump bypass graft surgery
Mini extracorporeal circulation bypass surgery
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 230 patients with indication for coronary surgery established on the basis of current published guidelines. All patients provided written consent to enter the study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical outcomes
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes:
measure: Determination of increase over the first 48 hours of plasma levels of 19 circulating markers of inflammatory response.
timeFrame: Area Under the Concentration-Time Curve (AUC 0-48 hours)
measure: Biochemical outcomes
timeFrame: Within the first 30 days (plus or minus 3 days) after surgery
measure: Operative results
timeFrame: Within the first 30 days (plus or minus 3 days) after surgery
measure: Operative results
timeFrame: Within the first 30 days (plus or minus 3 days) after surgery
measure: Operative results
timeFrame: Within the first 30 days (plus or minus 3 days) after surgery
measure: Operative results
timeFrame: Within the first 30 days (plus or minus 3 days) after surgery
measure: Operative results
timeFrame: Within the first 30 days (plus or minus 3 days) after surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
citation: Permanyer E, Munoz-Guijosa C, Padro JM, Ginel A, Montiel J, Sanchez-Quesada JL, Vila L, Camacho M. Mini-extracorporeal circulation surgery produces less inflammation than off-pump coronary surgery. Eur J Cardiothorac Surg. 2020 Mar 1;57(3):496-503. doi: 10.1093/ejcts/ezz291.