Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT02108093
Status:
UNKNOWN
Last Update Posted:
2014-12-25
First Post:
2014-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-24', 'studyFirstSubmitDate': '2014-04-05', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2014-12-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prolonged intraoperative cerebral desaturation', 'timeFrame': 'Participants will be followed for the duration of the operation period, an expected average of 3 hours', 'description': 'The primary study parameter of this study is prolonged intraoperative cerebral desaturation and will be assessed by rSO2 desaturation score50. rSO2 desaturation score50 \\> 3000 is associated with increased risk of cognitive decline. Formula described by Slater et al. : rSO2 score = 50% rSO2 - current rSO2 (%) x time (s) will be used to calculate the rSO2 score; from the intraoperative cerebral oximetry data.'}], 'secondaryOutcomes': [{'measure': 'cerebral oxygenation desaturation episodes (CODE)', 'timeFrame': 'participants will be followed for the duriation of the operation period, an expected average of 3 hours', 'description': 'CODE will be defined by a reduction of 20% baseline value of rSO2 at least one minute or an absolute reduction of 50%'}, {'measure': 'Subjective Cognitive Failure Questionnaire (CFQ)', 'timeFrame': '3 months and 6 months after randomization', 'description': 'Three and six months after randomization the Subjective CFQ will be sent to the patients to evaluate cognition.'}, {'measure': 'blood transfusions (amount)', 'timeFrame': 'participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks', 'description': 'The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Cognitive Dysfunction']}, 'referencesModule': {'references': [{'pmid': '19101265', 'type': 'BACKGROUND', 'citation': 'Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.'}, {'pmid': '20650659', 'type': 'BACKGROUND', 'citation': 'de Tournay-Jette E, Dupuis G, Bherer L, Deschamps A, Cartier R, Denault A. The relationship between cerebral oxygen saturation changes and postoperative cognitive dysfunction in elderly patients after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):95-104. doi: 10.1053/j.jvca.2010.03.019. Epub 2010 Jul 22.'}, {'pmid': '16939113', 'type': 'BACKGROUND', 'citation': 'Murkin JM. Pathophysiological basis of CNS injury in cardiac surgical patients: detection and prevention. Perfusion. 2006 Jul;21(4):203-8. doi: 10.1191/0267659106pf869oa.'}, {'pmid': '21576024', 'type': 'BACKGROUND', 'citation': 'Hwang J, Huh J, Kim J, Park S, Hwang J, Nahm FS, Hahn S. The effect of retrograde autologous priming of the cardiopulmonary bypass circuit on cerebral oxygenation. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):995-9. doi: 10.1053/j.jvca.2011.02.017. Epub 2011 May 14.'}, {'pmid': '21357641', 'type': 'BACKGROUND', 'citation': 'Anastasiadis K, Argiriadou H, Kosmidis MH, Megari K, Antonitsis P, Thomaidou E, Aretouli E, Papakonstantinou C. Neurocognitive outcome after coronary artery bypass surgery using minimal versus conventional extracorporeal circulation: a randomised controlled pilot study. Heart. 2011 Jul;97(13):1082-8. doi: 10.1136/hrt.2010.218610. Epub 2011 Feb 28.'}]}, 'descriptionModule': {'briefSummary': "The effect of retrograde autologous priming (RAP) on regional cerebral oxygenation (rSO2) still remains unclear, because studies are limited in sample size and study design, and because of the absence of prospective studies. The investigators hypothesize that RAP limits the degree of hemodilution and thereby limits prolonged intraoperative cerebral desaturation during cardiopulmonary bypass (CPB), compared to the conventional priming method.\n\nThe primary objective of this study is to determine whether RAP limits the degree of hemodilution and limits prolonged intraoperative cerebral desaturation during cardiopulmonary bypass, compared to the conventional priming method. Prolonged intraoperative cerebral desaturation will be assessed by rSO2 desaturation score50. rSO2 desaturation score50 \\> 3000 is associated with increased risk of cognitive decline. The investigators hypothesize that RAP limits the degree of hemodilution and thereby limits the incidence of rSO2 desaturation score50 \\> 3000 with a relative difference of 50%.\n\nThe subjects who are divided in the RAP group, the retrograde autologous priming technique will be used, where the patient's own circulating blood partially will be replaced by the priming solution in the cardiopulmonary bypass. In the Control group the conventional priming method will be used. The main study parameters is rSO2 desaturation score50."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective combined cardiac surgical procedures\n\nExclusion Criteria:\n\n* Elective single cardiac surgical procedures\n* off-pump procedure\n* re-operation\n* emergency operation\n* methylene blue administration'}, 'identificationModule': {'nctId': 'NCT02108093', 'acronym': 'RAP', 'briefTitle': 'The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Amphia Hospital'}, 'officialTitle': 'The Effect on Cerebral Oxygenation of Retrograde Autologous Priming of the Cardiopulmonary Bypass Circuit in Cardiac Surgery Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RAP (retrograde autologous priming) group', 'description': "In the RAP (retrograde autologous priming) group, the priming solution is partially replaced by the patient's own circulating blood, before initiation of CPB. After initiation of cardiopulmonary bypass the priming volume is approximately 900 ml.", 'interventionNames': ['Procedure: retrograde autologous priming']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "In the control group, the priming volume of the arterial and venous line will not be replaced by patient's own blood. The priming volume of cardiopulmonary bypass is 1300 ml in the control group."}], 'interventions': [{'name': 'retrograde autologous priming', 'type': 'PROCEDURE', 'otherNames': ['RAP'], 'description': "Retrograde autologous priming (RAP) is a technique where, the patient's own circulating blood partially replaces the priming solution in the CPB.", 'armGroupLabels': ['RAP (retrograde autologous priming) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4800 RK', 'city': 'Breda', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Thierry Scohy, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bas Gerritse, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nardo van der Meer, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dorien Kimenai, Bsc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Amphia Hospital', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}], 'centralContacts': [{'name': 'Dorien Kimenai, Bsc', 'role': 'CONTACT', 'email': 'dkimenai@amphia.nl'}, {'name': 'Thierry Scohy, MD, PhD', 'role': 'CONTACT', 'email': 'tscohy@amphia.nl'}], 'overallOfficials': [{'name': 'Thierry Scohy, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amphia Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amphia Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Thierry V Scohy', 'investigatorAffiliation': 'Amphia Hospital'}}}}