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Evaluation of Prophylactic Use of a Preoperative IABP in High-Risk Coronary Artery Bypass Graft Surgery

NCT03857906 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 129

Last updated 2019-03-06

No results posted yet for this study

Summary

Background: The intra-aortic balloon balloon pump (IABP) has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery (CABG); Although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due to cardiogenic shock associated with postoperative acute myocardial infarction (AMI), the real benefit reducing mortality in the postoperative context (PO) has not been determined examined through a prospective study with an adequate design.

Objective: To compare PO complications such as mortality, perioperative infarction and other complications in patients with high surgical risk undergoing CABG in comparison with controls.

Conditions

Interventions

DEVICE

Intra-Aortic Ballon Pump insertion

The IABP (Ultraflex IAB 7.5F, 2.5mm; Arrow International, Reading, PA) was inserted percutaneously through the right femoral artery in the previous 1 - 6 hours before the scheduled surgery. Positioning of the IABP was guided by radioscopy. The balloon size was based on the patient's height (30, 40 or 50 cc). Transesophageal echocardiography was used to confirm correct IABP placement before and after CABG

Sponsors & Collaborators

  • Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

    collaborator OTHER_GOV

  • CMN "20 de Noviembre"

    lead OTHER

Principal Investigators

  • Juán Antonio Suárez-Cuenca · CMN "20 de Noviembre"

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-21
Primary Completion
2018-02-21
Completion
2019-01-19
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03857906 on ClinicalTrials.gov