Bleeding and Blood Transfusion in MVR

October 21, 2022 updated by: Mustafa Loay Mohammed, Assiut University

Bleeding and Needs for Blood Transfusion in Mitral Valve Replacement, Comparison Between Median Sternotomy and Minimally Invasive Approach.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged between 18-80 years old, males or females, undergoing mitral valve replacement through minimally invasive or median sternotomy at Assiut Cardiothoracic surgery department.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MVR through Median sternotomy
Procedure: Mitral valve replacement
Mitral valve replacement through median sternotomy and minimally invasive approach
MVR through Minimally invasive approach
Procedure: Mitral valve replacement
Mitral valve replacement through median sternotomy and minimally invasive approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding
Time Frame: Baseline
Amount of post operative bleeding per drains
Baseline
Blood transfusion
Time Frame: Baseline
Amount of blood products transfused
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reexploration
Time Frame: Baseline
Number of patients re-explored due to massive bleeding
Baseline
Complications of blood transfusion
Time Frame: Baseline
Complications of blood transfusion
Baseline
ICU stay
Time Frame: Baseline
Numbered of days patient stayed in ICU
Baseline
Cost effectiveness
Time Frame: Baseline
Financial aspect
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bleeding in MVR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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