Prophylactic IABP in High-risk Patients Undergoing CABG

Not Applicable

Withdrawn

• Conditions: Myocardial Infarction; Coronary Artery Disease
• Interventions: Procedure: Preoperative IABC

• Registration Number: NCT01950130
• Lead Sponsor: University of Giessen

Brief Summary

Due to advances and increased practice of interventional therapy for coronary artery disease, the rate of high-risk patients with severe coronary disease and reduced left ventricular function among patients undergoing coronary artery bypass grafting surgery (CABG) is increasing. The perioperative mortality in these patients is ≥ 5%. The perioperative and operative management for these patients has to be optimized in order to reduce their perioperative morbidity and mortality. One of the central aspects is perioperative maintenance of hemodynamic stability. The use of prophylactic IABP is a partly established, but not sufficiently evidence-based measure to reduce ventricular afterload and improve coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive procedure with potential complications. The planned trial should give an explicit answer, whether preoperative prophylactic IABP decreases 30-day all-cause mortality (primary endpoint) and long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative conservative treatment in high-risk patients undergoing CABG.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-22
• Study First Posted: 2013-09-25
• Study Start: 2015-06
• Primary Completion: 2017-02
• Study Completion: 2018-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IABP group	Preoperative IABC	Preoperative IABP insertion

Primary Outcome Measures

Name	Time	Method
30-day all-cause mortality post CABG [%]	30 days

Secondary Outcome Measures

Name	Time	Method
Dependence on medical inotropic support	48 hours (average)
Survival at 3, 6, 12 months [%]	3, 6 and 12 months
Duration of ICU stay [h]	48 hours (average)
IABP-associated complications	8 days (average)	IABP-associated complications occur most often during IABP-support. However, after weaning from IABP, patients can still have bleeding complications or thrombembolic complications. Therefore, IABP-associated complications are monitored during the whole hospital stay

Trial Locations

Locations (1)

Department of Adult and Pediatric Cardiovascular Surgery; 🇩🇪 Giessen, Germany