Femorofemoral Bypass in Redo Cardiac Surgery

NCT ID: NCT03624738

Last Updated: 2019-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2019-03-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Heart Valve Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Femorofemoral bypass in redo cardiac surgery
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with redo cardiac surgery 1

Procedure: the patients will undergo femorofemoral bypass

Group Type ACTIVE_COMPARATOR

Procedure

Intervention Type 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

Patients with redo cardiac surgery 2

Procedure: the patients will undergo conventional Aortobicaval cannulation

Group Type ACTIVE_COMPARATOR

Procedure

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed mahmoud ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed mahmoud ahmed, Doctor

Role: PRINCIPAL_INVESTIGATOR

Lecturer of cardiothoracic surgery, Faculty of Medicine, Assiut University, Assiut, Egypt

Central Contacts

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Mohamed mahmoud ahmed, Doctor

Role: CONTACT

01008332462

References

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Kaneko T, Vassileva CM, Englum B, Kim S, Yammine M, Brennan M, Suri RM, Thourani VH, Jacobs JP, Aranki S. Contemporary Outcomes of Repeat Aortic Valve Replacement: A Benchmark for Transcatheter Valve-in-Valve Procedures. Ann Thorac Surg. 2015 Oct;100(4):1298-304; discussion 1304. doi: 10.1016/j.athoracsur.2015.04.062. Epub 2015 Jul 21.

Reference Type BACKGROUND
PMID: 26209480 (View on PubMed)

Agrifoglio M, Gennari M, Kassem S, Polvani G. Saphenous vein cannulation in re-redo cardiac surgery. J Card Surg. 2012 Nov;27(6):676-7. doi: 10.1111/jocs.12004. Epub 2012 Oct 15.

Reference Type BACKGROUND
PMID: 23061405 (View on PubMed)

Knight JL, Cohn LH. Left thoracotomy and femoro-femoral bypass for reoperative revascularization of the posterior coronary circulation. J Card Surg. 1987 Sep;2(3):343-9. doi: 10.1111/j.1540-8191.1987.tb00192.x.

Reference Type BACKGROUND
PMID: 2979983 (View on PubMed)

Other Identifiers

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Cardiac surgery

Identifier Type: -

Identifier Source: org_study_id

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