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Bleeding and Blood Transfusion in MVR

A

Assiut University

Status

Not yet enrolling

Conditions

Mitral Valve Disease

Treatments

Procedure: Mitral valve replacement

Study type

Observational

Funder types

Other

Identifiers

NCT05594420
Bleeding in MVR

Details and patient eligibility

About

To identify the best approach for mitral valve replacement to decrease risk of bleeding and restrict blood transfusion and its complication.

Full description

Mitral valve disease is the most common form of the valvular heart disorders including mitral regurgitation and mitral stenosis. Surgical treatment includes repair and replacement with different approaches as conventional median sternotomy or minimally invasive approaches.

Since minimally invasive mitral valve surgery (MMVS) was first described in the mid-to-late 1990s by pioneer surgeons Alain Carpentier and Randolph Chitwood, the techniques have evolved to include mini-thoracotomy, port-access thoracoscopic, partial sternotomy, and robotic. Right lateral mini-thoracotomy has become the standard approach for mitral valve surgery in many centers. These approaches may result in less surgical trauma, blood transfusions, and pain, thereby leading to a shorter hospital stay and faster return to daily activities. A reduction in postoperative hemorrhage and transfusion requirements have been suggested as a potential advantage of minimally invasive valve surgery. This benefit is important given the significant morbidity and mortality associated with transfusions and re-exploration for bleeding. Observational studies suggested that patients undergoing MMVS required fewer units of pRBCs transfused per patient and patients were at lower risk of transfusion. RCTs did not reach statistical significance. So, more studies were required to reach a definite conclusion.

Through this study our aim is to evaluate postoperative bleeding and needs for blood transfusion in conventional median sternotomy mitral valve replacement in comparison to minimally invasive approach.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing mitral valve replacement through minimally invasive or median sternotomy at Assiut Cardiothoracic surgery department.

Exclusion criteria

  • Patients refused to be enrolled in research. Emergency, redo procedures, active infectious endocarditis, and combined surgery (valve surgery and coronary artery bypass graft).

Trial design

40 participants in 2 patient groups

MVR through Median sternotomy
Treatment:
Procedure: Mitral valve replacement
MVR through Minimally invasive approach
Treatment:
Procedure: Mitral valve replacement

Trial contacts and locations

0

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Central trial contact

Mustafa Loay Shehata

Data sourced from clinicaltrials.gov

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