Bleeding and Blood Transfusion in MVR

Mitral Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05594420
• Other study ID #: Bleeding in MVR
• Status: Not yet recruiting
• Start date: December 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: Mustafa Loay Shehata
• Phone: +201065896733
• Email: musloay1996[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hemorrhage
• Mitral Valve Disease

Intervention

Procedure:
• Mitral valve replacement
Mitral valve replacement through median sternotomy and minimally invasive approach

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Sündermann 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bleeding	Amount of post operative bleeding per drains	Baseline
Primary	Blood transfusion	Amount of blood products transfused	Baseline
Secondary	Reexploration	Number of patients re-explored due to massive bleeding	Baseline
Secondary	Complications of blood transfusion	Complications of blood transfusion	Baseline
Secondary	ICU stay	Numbered of days patient stayed in ICU	Baseline
Secondary	Cost effectiveness	Financial aspect	Baseline