Bleeding and Blood Transfusion in MVR

NCT ID: NCT05594420

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Valve Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MVR through Median sternotomy

Mitral valve replacement

Intervention Type PROCEDURE

Mitral valve replacement through median sternotomy and minimally invasive approach

MVR through Minimally invasive approach

Mitral valve replacement

Intervention Type PROCEDURE

Mitral valve replacement through median sternotomy and minimally invasive approach

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mitral valve replacement

Mitral valve replacement through median sternotomy and minimally invasive approach

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mustafa Loay Mohammed

Resident Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mustafa Loay Shehata

Role: CONTACT

+201065896733

References

Explore related publications, articles, or registry entries linked to this study.

Nishimura RA, Vahanian A, Eleid MF, Mack MJ. Mitral valve disease--current management and future challenges. Lancet. 2016 Mar 26;387(10025):1324-34. doi: 10.1016/S0140-6736(16)00558-4.

Reference Type BACKGROUND
PMID: 27025438 (View on PubMed)

Carpentier A, Loulmet D, Carpentier A, Le Bret E, Haugades B, Dassier P, Guibourt P. [Open heart operation under videosurgery and minithoracotomy. First case (mitral valvuloplasty) operated with success]. C R Acad Sci III. 1996 Mar;319(3):219-23. French.

Reference Type BACKGROUND
PMID: 8761668 (View on PubMed)

Sundermann SH, Sromicki J, Rodriguez Cetina Biefer H, Seifert B, Holubec T, Falk V, Jacobs S. Mitral valve surgery: right lateral minithoracotomy or sternotomy? A systematic review and meta-analysis. J Thorac Cardiovasc Surg. 2014 Nov;148(5):1989-1995.e4. doi: 10.1016/j.jtcvs.2014.01.046. Epub 2014 Feb 5.

Reference Type BACKGROUND
PMID: 24589199 (View on PubMed)

Al Otaibi A, Gupta S, Belley-Cote EP, Alsagheir A, Spence J, Parry D, Whitlock RP. Mini-thoracotomy vs. conventional sternotomy mitral valve surgery: a systematic review and meta-analysis. J Cardiovasc Surg (Torino). 2017 Jun;58(3):489-496. doi: 10.23736/S0021-9509.16.09603-8. Epub 2016 Sep 2.

Reference Type BACKGROUND
PMID: 27588617 (View on PubMed)

Modi P, Hassan A, Chitwood WR Jr. Minimally invasive mitral valve surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2008 Nov;34(5):943-52. doi: 10.1016/j.ejcts.2008.07.057. Epub 2008 Sep 30.

Reference Type BACKGROUND
PMID: 18829343 (View on PubMed)

Eqbal AJ, Gupta S, Basha A, Qiu Y, Wu N, Rega F, Chu FV, Belley-Cote EP, Whitlock RP. Minimally invasive mitral valve surgery versus conventional sternotomy mitral valve surgery: A systematic review and meta-analysis of 119 studies. J Card Surg. 2022 May;37(5):1319-1327. doi: 10.1111/jocs.16314. Epub 2022 Feb 16.

Reference Type BACKGROUND
PMID: 35170791 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Bleeding in MVR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The China Mviv Registry
NCT05925335 UNKNOWN NA