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Clinical Trials/NCT01950130
NCT01950130
Withdrawn
N/A

Prophylactic Preoperative Inatraaortic Balloon Pump (IABP) in High-risk Patients Undergoing Coronary Artery Bypass Surgery (CABG)

University of Giessen1 site in 1 countryJune 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Myocardial Infarction
Sponsor
University of Giessen
Locations
1
Primary Endpoint
30-day all-cause mortality post CABG [%]
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
February 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Philippe Grieshaber

MD

University of Giessen

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

30-day all-cause mortality post CABG [%]

Time Frame: 30 days

Secondary Outcomes

  • Duration of ICU stay [h](48 hours (average))
  • IABP-associated complications(8 days (average))
  • Dependence on medical inotropic support(48 hours (average))
  • Survival at 3, 6, 12 months [%](3, 6 and 12 months)

Study Sites (1)

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