NCT03624738

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 17, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

July 28, 2018

Last Update Submit

January 8, 2019

Conditions

Heart Valve Diseases

Keywords

Femoro-femoral bypass

Outcome Measures

Primary Outcomes (1)

  • invasive monitoring of arterial blood pressure

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

    Baseline during operation

Study Arms (2)

Patients with redo cardiac surgery 1

ACTIVE COMPARATOR

Procedure: the patients will undergo femorofemoral bypass

Procedure: Procedure

Patients with redo cardiac surgery 2

ACTIVE COMPARATOR

Procedure: the patients will undergo conventional Aortobicaval cannulation

Procedure: Procedure

Interventions

ProcedurePROCEDURE

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 1Patients with redo cardiac surgery 2

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26209480BACKGROUND

  • 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.

    PMID: 23061405BACKGROUND

  • 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.

    PMID: 2979983BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Mohamed mahmoud ahmed, Doctor

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed mahmoud ahmed, Doctor

CONTACT

01008332462mohamedmahmoudclinic@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Femorofemoral bypass in redo cardiac surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2018

First Posted

August 10, 2018

Study Start

January 17, 2019

Primary Completion

March 28, 2019

Study Completion

March 30, 2019

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share