Mitral Valve DiseaseNCT05594420
Bleeding and Blood Transfusion in MVR
An observational study of Mitral Valve Disease, run by Assiut University.
Trial summary
To identify the best approach for mitral valve replacement to decrease risk of bleeding and restrict blood transfusion and its complication. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- Mitral valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing mitral valve replacement through minimally invasive or median sternotomy at Assiut Cardiothoracic surgery department.
Who cannot join
- Patients refused to be enrolled in research. Emergency, redo procedures, active infectious endocarditis, and combined surgery (valve surgery and coronary artery bypass graft).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mitral Valve Disease
- Being tested
- Mitral valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve replacementProcedure or surgery
Mitral valve replacement through median sternotomy and minimally invasive approach
| Study group | Role | What they receive |
|---|---|---|
| MVR through Median sternotomy | Not described Receives: Procedure: Mitral valve replacement | |
| MVR through Minimally invasive approach | Not described Receives: Procedure: Mitral valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding
Amount of post operative bleeding per drains
Measured: Baseline
Blood transfusion
Amount of blood products transfused
Measured: Baseline
Secondary outcomes (4)
Reexploration
Number of patients re-explored due to massive bleeding
Measured: Baseline
Complications of blood transfusion
Complications of blood transfusion
Measured: Baseline
ICU stay
Numbered of days patient stayed in ICU
Measured: Baseline
Cost effectiveness
Financial aspect
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Loay Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594420
- Sponsor's protocol ID
- Bleeding in MVR
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27025438Carpentier 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.
PubMed 8761668Sundermann 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.
PubMed 24589199Al 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.
PubMed 27588617Modi 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.
PubMed 18829343Eqbal 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.
PubMed 35170791
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding and Needs for Blood Transfusion in Mitral Valve Replacement, Comparison Between Median Sternotomy and Minimally Invasive Approach.
- ClinicalTrials.gov ID
- NCT05594420
- Acronym / sponsor ID
- Bleeding in MVR
- Conditions
- Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify the best approach for mitral valve replacement to decrease risk of bleeding and restrict blood transfusion and its complication.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MVR through Median sternotomy | – | Procedure: Mitral valve replacement |
| MVR through Minimally invasive approach | – | Procedure: Mitral valve replacement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients undergoing mitral valve replacement through minimally invasive or median sternotomy at Assiut Cardiothoracic surgery department.
Key exclusion criteria (1 listed)
- Patients refused to be enrolled in research. Emergency, redo procedures, active infectious endocarditis, and combined surgery (valve surgery and coronary artery bypass graft).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral valve replacementMitral valve replacement through median sternotomy and minimally invasive approach | Procedure or surgery | MVR through Median sternotomy, MVR through Minimally invasive approach |
Primary outcome
bleeding
Time frame: Baseline
Amount of post operative bleeding per drains
Blood transfusion
Time frame: Baseline
Amount of blood products transfused
4 secondary outcomes
Reexploration
Time frame: Baseline
Complications of blood transfusion
Time frame: Baseline
ICU stay
Time frame: Baseline
Cost effectiveness
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 27025438Nishimura 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.
- Background: PubMed 8761668Carpentier 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.
- Background: PubMed 24589199Sundermann 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.
- Background: PubMed 27588617Al 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.
- Background: PubMed 18829343Modi 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.
- Background: PubMed 35170791Eqbal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Loay Shehata (+201065896733, musloay1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05594420, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.