Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-05 @ 9:39 AM
Study NCT ID:
NCT05545956
Status:
WITHDRAWN
Last Update Posted:
2024-12-24
First Post:
2022-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Subjects will be blinded to the intervention.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due staffing issues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Units of Packed Red Blood Cells Transfused', 'timeFrame': 'Up to 72 Hours Post-Operative', 'description': 'Units of packed red blood cells transfused will be measured.'}, {'measure': 'Change in Level of Hematocrit', 'timeFrame': 'Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72', 'description': 'Level of hematocrit will be measured at baseline and post-operative.'}, {'measure': 'Change in Level of Plasma Free Hemoglobin', 'timeFrame': 'Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72', 'description': 'Level of plasma free hemoglobin will be measured at baseline and post-operative.'}, {'measure': 'Change in Volume of Blood', 'timeFrame': 'Baseline, Post-Processing (Up to 120 Minutes)', 'description': 'Volume of blood will be measured at baseline and post-processing.'}], 'secondaryOutcomes': [{'measure': 'Change in Number of Fragmented Red Blood Cells', 'timeFrame': 'Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72', 'description': 'Number of fragmented red blood cells will be measured at baseline and post-operative.'}, {'measure': 'Change in Level of Lactate Dehydrogenase', 'timeFrame': 'Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72', 'description': 'Level of lactate dehydrogenase will be measured at baseline and post-operative.'}, {'measure': 'Change in Level of Haptoglobin', 'timeFrame': 'Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72', 'description': 'Level of haptoglobin will be measured at baseline and post-operative.'}, {'measure': 'Change in Level of Bilirubin', 'timeFrame': 'Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72', 'description': 'Level of bilirubin will be measured at baseline and post-operative.'}, {'measure': 'Change in Weight of Surgical Sponge', 'timeFrame': 'Baseline, Post-Procedure (Up to 5 Minutes)', 'description': 'Weight of surgical sponges will be measured at baseline and post-procedure.'}, {'measure': 'Time to Wring Sponges', 'timeFrame': 'Up to 120 Minutes', 'description': 'Time in seconds to wring sponges will be measured.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Open Heart Surgery', 'Heart Transplant', 'Lung Transplant', 'ProCell'], 'conditions': ['Blood Recovery']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to compare two methods of recovering blood from surgical sponges used during heart and lung surgeries. The two methods are: 1) manually wringing sponges by hand, and 2) automated wringing sponges by an FDA approved suction device. Both methods are already in use in heart and lung surgeries at University Hospitals at the discretion of the surgeon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements; and\n* At University Hospitals Cleveland Medical Center.\n\nExclusion Criteria:\n\n* Patients with known bleeding disorders, including disseminated intravascular coagulation (DIC), prothrombin deficiency, factor V deficiency, factor VII deficiency, factor X deficiency, factor XI deficiency (hemophilia C), Glanzmann disease, hemophilia A, hemophilia B, idiopathic thrombocytopenic purpura (ITP), and Von Willebrand disease (types I, II, and III);\n* Patients undergoing emergent or emergent salvage surgery; and\n* Patients actively participating in another clinical trial which could affect outcomes.'}, 'identificationModule': {'nctId': 'NCT05545956', 'briefTitle': 'Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact', 'orgStudyIdInfo': {'id': 'STUDY20220888_2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hand Wrung', 'description': 'Hand wrung refers to manually wringing surgical sponges by hand.', 'interventionNames': ['Procedure: Hand Wrung']}, {'type': 'EXPERIMENTAL', 'label': 'ProCell Wrung', 'description': 'ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).', 'interventionNames': ['Device: ProCell Wrung']}], 'interventions': [{'name': 'Hand Wrung', 'type': 'PROCEDURE', 'description': 'Hand wrung refers to manually wringing surgical sponges by hand.', 'armGroupLabels': ['Hand Wrung']}, {'name': 'ProCell Wrung', 'type': 'DEVICE', 'description': 'ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).', 'armGroupLabels': ['ProCell Wrung']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Marc Pelletier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}, {'name': 'Craig Jarrett, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ProCell Surgical Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}