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Femorofemoral Bypass in Redo Cardiac Surgery

Primary Purpose

Heart Valve Diseases

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Procedure

About this trial

This is an interventional treatment trial for Heart Valve Diseases focused on measuring Femoro-femoral bypass

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Patients with redo cardiac surgery 1

Patients with redo cardiac surgery 2

Arm Description

Procedure: the patients will undergo femorofemoral bypass

Procedure: the patients will undergo conventional Aortobicaval cannulation

Outcomes

Primary Outcome Measures

invasive monitoring of arterial blood pressure

suitable systolic arterial blood pressure between 50 and 60 mmHg during cardiopulmonary bypass.

Secondary Outcome Measures

Full Information

NCT ID

NCT03624738

First Posted

July 28, 2018

Last Updated

January 8, 2019

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03624738

Brief Title

Femorofemoral Bypass in Redo Cardiac Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 17, 2019 (Anticipated)

Primary Completion Date

March 28, 2019 (Anticipated)

Study Completion Date

March 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Valve Diseases

Keywords

Femoro-femoral bypass

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Femorofemoral bypass in redo cardiac surgery

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with redo cardiac surgery 1

Arm Type

Active Comparator

Arm Description

Procedure: the patients will undergo femorofemoral bypass

Arm Title

Patients with redo cardiac surgery 2

Arm Type

Active Comparator

Arm Description

Procedure: the patients will undergo conventional Aortobicaval cannulation

Intervention Type

Procedure

Intervention Name(s)

Procedure

Intervention Description

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

Primary Outcome Measure Information:

Title

invasive monitoring of arterial blood pressure

Description

suitable systolic arterial blood pressure between 50 and 60 mmHg during cardiopulmonary bypass.

Time Frame

Baseline during operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed mahmoud ahmed, Doctor

Phone

01008332462

mohamedmahmoudclinic@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed mahmoud ahmed, Doctor

Organizational Affiliation

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

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26209480

Citation

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.

Results Reference

background

PubMed Identifier

23061405

Citation

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.

Results Reference

background

PubMed Identifier

2979983

Citation

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.

Results Reference

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Femorofemoral Bypass in Redo Cardiac Surgery

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