Femorofemoral Bypass in Redo Cardiac Surgery

January 8, 2019 updated by: Mohamed mahmoud ahmed, Assiut University

Femorofemoral Bypass in Redo Cardiac Surgery: A Safe and Effective Operative Technique

Redo cardiac surgery are becoming more common with a patient population at greater risk. Sternal re-entry poses the hazard of probable injury to vital structures. To minimize the risk associated with sternal re-entry, the investigators adopted the method of establishing femoral artery-femoral vein cardiopulmonary bypass (CPB).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Redo cardiac surgery are more frequent with a patient population at greater risk. Repeat sternal entry poses the risk of possible injury to vital structures. These include laceration of the myocardium, especially the right ventricle, injury of great vessels or crossing coronary bypass grafts as the internal mammary grafts in particular, or dislodgement of emboli from patent vein grafts. To minimize the risk associated with sternal re-entry, the investigators adopted the method of establishing femoral artery-femoral vein cardiopulmonary bypass (CPB) in order to achieve cardiac drain prior to sternotomy. Also, femorofemoral bypass support the hemodynamics in cases of redo emergency cardiac surgery.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 25-65 years old
  • Patients scheduled for repeat open heart surgery with sternotomy
  • informed consent has been obtained

Exclusion Criteria:

  • Planned off-pump cardiac surgery
  • Vascular disease
  • previous operation on femoral artery
  • under 25 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients with redo cardiac surgery 1
Procedure: the patients will undergo femorofemoral bypass
Procedure: Procedure

Patients with redo cardiac surgery 1: femoral artery-femoral vein cardiopulmonary bypass (CPB) in order to achieve cardiac decompression prior to sternotomy.

Patients with redo cardiac surgery 2: only conventional aortobicaval cannulation will be used
Active Comparator: Patients with redo cardiac surgery 2
Procedure: the patients will undergo conventional Aortobicaval cannulation
Procedure: Procedure

Patients with redo cardiac surgery 1: femoral artery-femoral vein cardiopulmonary bypass (CPB) in order to achieve cardiac decompression prior to sternotomy.

Patients with redo cardiac surgery 2: only conventional aortobicaval cannulation will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
invasive monitoring of arterial blood pressure
Time Frame: Baseline during operation
suitable systolic arterial blood pressure between 50 and 60 mmHg during cardiopulmonary bypass.
Baseline during operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohamed mahmoud ahmed, Doctor, Lecturer of cardiothoracic surgery, Faculty of Medicine, Assiut University, Assiut, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 17, 2019

Primary Completion (Anticipated)

March 28, 2019

Study Completion (Anticipated)

March 30, 2019

Study Registration Dates

First Submitted

July 28, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 10, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardiac surgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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