Outcomes of Total Arterial Coronary Artery Bypass Grafting

Withdrawn

• Conditions: Coronary Artery Disease; Surgical Wound Infection
• Interventions: Procedure: coronary artery bypass grafting (CABG)

• Registration Number: NCT03231527
• Lead Sponsor: University of Glasgow

Brief Summary

"real-life" retrospective multicentric database for the analysis of the long term outcomes of total arterial CABG in comparison to saphenous vein based CABG

Detailed Description

This aim of this registry is to create a multi centric database for the analysis of basic long term outcomes and immediate postoperative outcomes of total arterial CABG in comparison to saphenous vein based CABG. The registry will include both on pump and off pump surgery. The registry is intended to capture the "real-life" picture of the CABG scenario among centers worldwide

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-27
• Primary Completion: 2018-11
• Study Completion: 2018-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• elective CABG patients (on pump or off pump surgery; pedicles of skletonized internal mammary artery harvesting technique; open or endoscopic vein harvesting technique)

Exclusion Criteria

• urgent or emergent CABG
• concomitant procedures
• redo cases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total Arterial coronary CABG	coronary artery bypass grafting (CABG)	Total Arterial revascularization
Saphenous vein based CABG	coronary artery bypass grafting (CABG)	Saphenous vein based revascularization

Primary Outcome Measures

Name	Time	Method
Survival	data collection every year up to 5 years after operation/entry in the registry	Long term survival
MACCEs	data collection every year up to 5 years after operation/entry in the registry	Major cardiac events (myocardial infarction, stroke, readmission for CHF)
target vessel revascularization	data collection every year up to 5 years after operation/entry in the registry	readmission for revascularization due to graft failure
Wound infection	data collection every year up to 5 years after operation/entry in the registry	Readmission for wound infection (superficial sternal wound infection, deep sternal wound infection, saphenous vein related wound infection, need for VAC therapy, need for surgical debridment, need for prolonged antibiotic therapy)

Secondary Outcome Measures

Name	Time	Method
Bleeding	perioperative (in hospital)	surgical bleeding requiring re-exploration
Duration of ventilation	perioperative (in hospital)	number of hours ventilated
Blood product usage	perioperative (in hospital)	unit of concentrated red cells, fresh frozen plasma, platelets
Length of ICU stay	perioperative (in hospital)	number of days in ICU
Length of hospital stay	perioperative (in hospital)	number of days in hospital
Cardiac complication	perioperative (in hospital)	prolonged inotropic support (more than 48 hrs), IABP, ECMO
Respiratory complications	perioperative (in hospital)	pneumonia, reintubation, pneumothorax requiring drainage, effusion requiring drainage
Renal complications	perioperative (in hospital)	acute kidney injury not requiring dyalisis, dialysis
GI complications	perioperative (in hospital)	mesenteric ischemia requiring surgery, ileus

Trial Locations

Locations (4)

Campus St Ian; 🇧🇪 Genk, Belgium

Thoracic Centrum Twente; 🇳🇱 Enschede, Netherlands

University Campus Bio-Medico; 🇮🇹 Rome, Italy

Golden Jubilee National Hospital; 🇬🇧 Glasgow, United Kingdom