Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT06096051
Status:
UNKNOWN
Last Update Posted:
2023-10-23
First Post:
2023-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-07-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2023-10-17', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine safety and effectiveness of 4F-PCC', 'timeFrame': '12 hours', 'description': 'fixed-dose 4F-PCC is safe and effective in patients with DOAC-associated ICH when compared to weight-based dosing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracranial Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '29262016', 'type': 'BACKGROUND', 'citation': 'Tenny S, Das JM, Thorell W. Intracranial Hemorrhage. 2024 Feb 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470242/'}]}, 'descriptionModule': {'briefSummary': 'Intracranial hemorrhage (ICH) can occur due to traumatic and spontaneous events.1 The incidence of non-traumatic, spontaneous ICH is approximately 40,000 to 67,000 cases per year while the incidence of traumatic brain injury (TBI) is nearly 1.7 million annually', 'detailedDescription': 'The authors found that AC use preinjury was associated with ICH progression, immediate neurosurgery intervention, and death after initial scan. AC use has also been associated with worse functional outcomes, and patients are less likely to be discharged home compared to those without AC use prior to injury.6 With increasing prevalence of AC, hospitals are seeing admissions for ICH, making knowledge of optimal AC reversal essential.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients 18 years of age\n\n* ICH (traumatic and spontaneous)\n* Administration of at least one dose of 4F-PCC\n* Admitted to the MHS between July 1, 2018 and May 30, 2023\n* Rivaroxaban or apixaban use prior to admission', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • ≥18 years of age\n\n * ICH (traumatic and spontaneous)\n * Administration of at least one dose of 4F-PCC\n * Admitted to the MHS between July 1, 2018 and May 30, 2023\n * Rivaroxaban or apixaban use prior to admission\n\nExclusion Criteria:\n\n* • Warfarin or dabigatran use prior to admission\n\n * Prisoners\n * Pregnancy\n * \\<18 years of age'}, 'identificationModule': {'nctId': 'NCT06096051', 'briefTitle': 'Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage', 'orgStudyIdInfo': {'id': '027.PHA.2023.A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Use of fixed-dosed 4F-PCC', 'type': 'PROCEDURE', 'description': 'Determine if fixed-dose 4F-PCC is safe and effective in patients with DOAC-associated ICH when compared to weight-based dosing.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bethany Brauer, MPH', 'role': 'CONTACT', 'email': 'mhsirb@mhd.com', 'phone': '214-947-4681'}, {'name': 'Colette Ngo Ndjom, MS', 'role': 'CONTACT', 'email': 'mhsirb@mhd.com', 'phone': '217-947-4681'}], 'facility': 'Methodist Dallas Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Bethany Brauer, MPH', 'role': 'CONTACT', 'email': 'MHSIRB@mhd.com', 'phone': '214-947-1281'}, {'name': 'Colette Ngo Ndjom, MS', 'role': 'CONTACT', 'email': 'mhsirb@mhd.com', 'phone': '214-947-4681'}], 'overallOfficials': [{'name': 'Tamara Reiter, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Methodist Midlothian Medical Center'}]}, 'ipdSharingStatementModule': {'timeFrame': '2 years', 'ipdSharing': 'YES', 'description': 'Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}