Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT05491356
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2022-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Tissue Plasminogen Activator in the Clearance of Chronic Subdural Hematomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study Feasibility', 'timeFrame': '8 months', 'description': 'Patient recruitment rate, eligibility of patients, protocol adherence, unexpected events'}], 'secondaryOutcomes': [{'measure': 'Reoperation rate', 'timeFrame': '8 months', 'description': 'Reoperation rate in the first 6 weeks post drainage'}, {'measure': 'Volume of chronic subdural hematoma', 'timeFrame': '8 months', 'description': 'Volume, as measured in 3 intervals: pre-procedure, post-procedure at 24hrs and 6 weeks'}, {'measure': 'Rate of adverse events', 'timeFrame': '8 months', 'description': 'Rate of adverse events in the first 6 weeks post procedure, including CNS infection, seizure, post-op hemorrhage'}, {'measure': 'Length of hospital stay', 'timeFrame': '8 months', 'description': 'length of hospital stay in days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematoma, Subdural', 'Fibrinolytic; Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '22120294', 'type': 'BACKGROUND', 'citation': 'Neils DM, Singanallur PS, Wang H, Tracy P, Klopfenstein J, Dinh D, Elwood PW, Fassett D, McCall T, Lin J, Tsung A. Recurrence-free chronic subdural hematomas: a retrospective analysis of the instillation of tissue plasminogen activator in addition to twist drill or burr hole drainage in the treatment of chronic subdural hematomas. World Neurosurg. 2012 Jul;78(1-2):145-9. doi: 10.1016/j.wneu.2011.08.032. Epub 2011 Nov 7.'}, {'pmid': '32025399', 'type': 'BACKGROUND', 'citation': 'Brazdzionis J, Patchana T, Wiginton JG 4th, Wacker MR, Menoni R, Miulli DE. Intracatheter Tissue Plasminogen Activator for Chronic Subdural Hematomas after Failed Bedside Twist Drill Craniostomy: A Retrospective Review. Cureus. 2019 Dec 26;11(12):e6472. doi: 10.7759/cureus.6472.'}, {'pmid': '33722722', 'type': 'BACKGROUND', 'citation': 'O YM, Tsang SL, Leung GK. Fibrinolytic-Facilitated Chronic Subdural Hematoma Drainage-A Systematic Review. World Neurosurg. 2021 Jun;150:e408-e419. doi: 10.1016/j.wneu.2021.03.029. Epub 2021 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'To determine the utility of tissue plasminogen activator (tPA) in the clearance of chronic subdural hematomas (CSDH). Intra-catheter tPA will be administered during surgical procedure and allowed to break down blood clot to assist with removal/drainage during twist drill craniostomy procedure.', 'detailedDescription': 'A chronic subdural hematoma (CSDH) is a collection of blood overlying the brain that can be seen, usually in the elderly with even minimal head trauma. These are usually treated by removing the collection of blood. This can be done through a small drill hole in the skull or by larger holes (one or two) the size of a nickel. Sometimes a larger piece of skull is removed to be able to remove the CSDH. The standard practice at our center is to do these procedures under local anesthesia with a twist drill craniostomy (small drill hole through the skull). In some cases, all the CSDH can not be removed the first time, requiring a second procedure or a larger procedure. This study plans to use a type of medication that breaks down the solid blood clot, enabling more of it to drain. This medication (tpa) is already used in other surgeries and is safe to use in humans. Our preliminary experience and that of others suggests very low risk at the dosages being used. We hope that using this new drug will decrease the chance of the CSDH collecting again and reduce the overall length of your stay in the hospital and reduce the need for further surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients (18 yrs or older)\n2. Admitted to neurosurgery wing at the hospital\n3. Symptomatic patients requiring surgical drainage by twist drill craniostomy\n\nExclusion Criteria:\n\n1. Patients at increased risk of bleeding such as patients taking anticoagulation medication that required reversal at time of interventionŲ or those with coagulopathic disorder.\n2. Patients on antiplatelets or anticoagulation medications (DOACs or warfarin) with appropriate holding period prior to drainage, those who are eventually minimized to a regular bleeding risk compared to the normal population, will be included in the study.\n3. Patients with subdural empyema.\n4. Redo twist drill craniostomy for residual cSDH within the same admission.\n5. Drain accidentally removed during nursing care or patient transport before 24 hr interval scan.\n6. Patients who are not expected to live more than three months.'}, 'identificationModule': {'nctId': 'NCT05491356', 'briefTitle': 'Use of Tissue Plasminogen Activator in the Clearance of Chronic Subdural Hematomas', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'The Utility of Intra-Catheter Fibrinolytics in Draining Chronic Subdural Hematomas: A Randomized Controlled Trial Pilot Study', 'orgStudyIdInfo': {'id': '14724'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention - tPA administered', 'description': 'This group will receive 2mL of intra-catheter tPA during twist drill craniostomy procedure', 'interventionNames': ['Drug: Tissue Plasminogen Activator']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'This group will receive 2mL of intra-catheter saline solution during twist drill craniostomy procedure', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tissue Plasminogen Activator', 'type': 'DRUG', 'description': 'Dosage of 1mg/mL mixed in 0.9% saline solution, intra-catheter administration, sterile', 'armGroupLabels': ['Intervention - tPA administered']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.9% saline solution, intra-catheter administration, sterile', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Dr. Kesava Reddy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamilton Health Sciences Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Patient data will be de-identified and the data will be analyzed as a whole before becoming available to other researchers.\n\nDe-identified IPD may be shared with other researchers if necessary based on occurrence of adverse events occurrence, circumstantial findings, etc.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}