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