Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT05594420
Status:
UNKNOWN
Last Update Posted:
2022-10-26
First Post:
2022-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bleeding and Blood Transfusion in MVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-21', 'studyFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bleeding', 'timeFrame': 'Baseline', 'description': 'Amount of post operative bleeding per drains'}, {'measure': 'Blood transfusion', 'timeFrame': 'Baseline', 'description': 'Amount of blood products transfused'}], 'secondaryOutcomes': [{'measure': 'Reexploration', 'timeFrame': 'Baseline', 'description': 'Number of patients re-explored due to massive bleeding'}, {'measure': 'Complications of blood transfusion', 'timeFrame': 'Baseline', 'description': 'Complications of blood transfusion'}, {'measure': 'ICU stay', 'timeFrame': 'Baseline', 'description': 'Numbered of days patient stayed in ICU'}, {'measure': 'Cost effectiveness', 'timeFrame': 'Baseline', 'description': 'Financial aspect'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Valve Disease']}, 'referencesModule': {'references': [{'pmid': '27025438', 'type': 'BACKGROUND', '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.'}, {'pmid': '8761668', 'type': 'BACKGROUND', '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.'}, {'pmid': '24589199', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27588617', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18829343', 'type': 'BACKGROUND', '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.'}, {'pmid': '35170791', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'To identify the best approach for mitral valve replacement to decrease risk of bleeding and restrict blood transfusion and its complication.', 'detailedDescription': '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.\n\nSince 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.\n\nThrough 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing mitral valve replacement through minimally invasive or median sternotomy at Assiut Cardiothoracic surgery department.\n\nExclusion Criteria:\n\n* Patients refused to be enrolled in research. Emergency, redo procedures, active infectious endocarditis, and combined surgery (valve surgery and coronary artery bypass graft).'}, 'identificationModule': {'nctId': 'NCT05594420', 'briefTitle': 'Bleeding and Blood Transfusion in MVR', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Bleeding and Needs for Blood Transfusion in Mitral Valve Replacement, Comparison Between Median Sternotomy and Minimally Invasive Approach.', 'orgStudyIdInfo': {'id': 'Bleeding in MVR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MVR through Median sternotomy', 'interventionNames': ['Procedure: Mitral valve replacement']}, {'label': 'MVR through Minimally invasive approach', 'interventionNames': ['Procedure: Mitral valve replacement']}], 'interventions': [{'name': 'Mitral valve replacement', 'type': 'PROCEDURE', 'description': 'Mitral valve replacement through median sternotomy and minimally invasive approach', 'armGroupLabels': ['MVR through Median sternotomy', 'MVR through Minimally invasive approach']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mustafa Loay Shehata', 'role': 'CONTACT', 'email': 'musloay1996@gmail.com', 'phone': '+201065896733'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Doctor', 'investigatorFullName': 'Mustafa Loay Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}