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Femorofemoral Bypass in Redo Cardiac Surgery

A

Assiut University

Status

Unknown

Conditions

Heart Valve Diseases

Treatments

Procedure: Procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT03624738
Cardiac surgery

Details and patient eligibility

About

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).

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Patients with redo cardiac surgery 1
Active Comparator group
Description:
Procedure: the patients will undergo femorofemoral bypass
Treatment:
Procedure: Procedure
Patients with redo cardiac surgery 2
Active Comparator group
Description:
Procedure: the patients will undergo conventional Aortobicaval cannulation
Treatment:
Procedure: Procedure

Trial contacts and locations

0

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Central trial contact

Mohamed mahmoud ahmed, Doctor

Data sourced from clinicaltrials.gov

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