Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-04-15 @ 4:10 PM
Study NCT ID:
NCT01941459
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2012-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Blood Cardioplegia and Custodiol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-04-08', 'releaseDate': '2014-02-28'}, {'resetDate': '2014-08-30', 'releaseDate': '2014-08-20'}, {'resetDate': '2014-10-20', 'releaseDate': '2014-10-12'}], 'estimatedResultsFirstSubmitDate': '2014-02-28'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-12', 'studyFirstSubmitDate': '2012-05-07', 'studyFirstSubmitQcDate': '2013-09-12', 'lastUpdatePostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CK-MB ,troponin-T', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CK-MB', 'troponin-T'], 'conditions': ['Mitral Insufficiencies', 'Myocardial Protection']}, 'descriptionModule': {'briefSummary': "Thru the last 20 years it has been a discussion witch solution that gives the best myocardial protection during cardiac arrest by heart operations.\n\n* It has been a tendency that a blood based cardioplegia gives a better protection bye long ischemic times but it has not been possible too conclude in this matter.\n* The investigators have two groups of cardioplegia, the blood based and, the crystalloid based cardioplegia.\n* It has been done a lot of studies to see what kind of cardioplegia that gives the best myocardial protection. Different temperature, different amount and content, retrograde or antegrade or both, contentiously and further on have been tested without a clear conclusion.\n* The investigators decided to make a study with a cohort of patients as homogenous as possible with a cross clamp time around 70 min.\n* Adult patients' with a severe aortic stenoses without any other significant heart disease was included in our prospective randomised study.\n* Patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study.\n* The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the myocardial damage.", 'detailedDescription': 'Objective: Myocardial protection during a cardiac arrest is mostly managed with cardioplegia. To day we normally used a blood or crystalloid based solutions. It has been published a lot of papers comparing the too groups with different results. To our knowledge no prospective, randomized study has compared modified St Thomas based Blood and Crystalloid cardioplegia on the acknowledged markers (CK-MB, troponin-T) of myocardial damage during aortic valve replacement on patients without additional significant coronary artery disease.\n\nMethods: 100 patients with aorta stenoses undergoing aortic valve replacement without significant coronary artery stenoses or other significant concomitant heart valve disease were included in the study. They were given antegrade cold blood or cold crystalloid cardioplegia delivered through the coronary Ostia every 20 min throughout the period of aortic cross-clamp. CK-MB and troponin-T were compared between the two groups.\n\nPublished 2010 in the journal of thoracic and cardiovascular surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Between Mars 2007 and December 2009, 80 consecutive patients undergoing elective mitral valve surgery for mitral regurgitation at Oslo University Hospital Ullevål, Oslo, Norway and Sahlgrenska University Hospital, Gothenburg, Sweden were included in the study after informed written consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'The study protocol was approved by the local ethical committees. Eligible for operation were:\n\nInclution Criteria\n\n* patients with mitral regurgitation equal to or larger than grade 3 out of 4.\n* Ablation for atrial fibrillation was the only concomitant procedure that was allowed in addition to mitral valve surgery and these patients were block-randomized to ensure equally many patients with ablation in the two groups of cardioplegia.\n\nExclusion Criteria\n\n* Patients with any other concomitant heart valve disease or coronary artery stenoses (≥ 50%) were excluded from the study.\n* Age below 18\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT01941459', 'briefTitle': 'Comparison of Blood Cardioplegia and Custodiol', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Comparison of Blood Cardioplegia and Custodiol on Patients Operated for Significant Mitral Valve Innsufisiens. An Prospective, Randomized Two-center Study.', 'orgStudyIdInfo': {'id': '2007-001780-30'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 Custodiol', 'description': 'Custodiol'}, {'label': '2 Blood cardioplegia', 'description': 'Blood cardioplegia'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'thoraxkirurgisk avd, UUS', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Theis Tønnessen, prof.dr.med', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Thoraxkirurgisk avd. UUS'}, {'name': 'Bjørn Braathen, med.doc', 'role': 'STUDY_CHAIR', 'affiliation': 'Thoraxkir.avd. UUS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. Ph.D', 'investigatorFullName': 'Bjørn Braathen', 'investigatorAffiliation': 'Oslo University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-02-28', 'type': 'RELEASE'}, {'date': '2014-04-08', 'type': 'RESET'}, {'date': '2014-08-20', 'type': 'RELEASE'}, {'date': '2014-08-30', 'type': 'RESET'}, {'date': '2014-10-12', 'type': 'RELEASE'}, {'date': '2014-10-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Bjørn Braathen, MD. Ph.D, Oslo University Hospital'}}}}