search
Back to results

Femorofemoral Bypass in Redo Cardiac Surgery

Primary Purpose

Heart Valve Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Procedure
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    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

    First Posted
    July 28, 2018
    Last Updated
    January 8, 2019
    Sponsor
    Assiut University
    search

    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
    No
    Studies a U.S. FDA-regulated Device Product
    No

    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
    No
    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
    Email
    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
    No
    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
    background

    Learn more about this trial

    Femorofemoral Bypass in Redo Cardiac Surgery

    We'll reach out to this number within 24 hrs