Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-25 @ 5:09 AM
Study NCT ID:
NCT05649904
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2022-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D006408', 'term': 'Hematoma, Subdural'}], 'ancestors': [{'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': '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'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2022-12-05', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of revision procedures for the IRRAflow and EVD/Drainage catheters', 'timeFrame': 'Immediately post-procedure'}], 'secondaryOutcomes': [{'measure': 'Time to clearance of blood or bacterial mass as measured by head CT scan', 'timeFrame': 'Immediately post-procedure'}, {'measure': 'Rate of catheter-related infection', 'timeFrame': 'Immediately post-procedure'}, {'measure': 'Length of ICU stay', 'timeFrame': 'Baseline'}, {'measure': 'Rate of shunt dependency', 'timeFrame': 'Immediately post-procedure'}, {'measure': 'Indwell time of EVD/Drainage and IRRAflow Catheter', 'timeFrame': 'Immediately post-procedure'}, {'measure': 'Functional Status - at inclusion and 30 days', 'timeFrame': '30 days post subject discharge', 'description': 'The Modified Rankin Scale will be used to assess functional status. The Modified Rankin Scale ranges from 0 (no disability) to 6 (death).'}, {'measure': 'Mortality rates - intraprocedural and at 30 days', 'timeFrame': '30 days post subject discharge'}, {'measure': 'Functional Status - at inclusion and 30 days', 'timeFrame': '30 days post subject discharge', 'description': 'The Extended Glasgow Coma Scale will be used to assess functional status. Results range from 1 (death) to 8 (upper good recovery).'}, {'measure': 'Functional Status - at inclusion and 30 days', 'timeFrame': '30 days post subject discharge', 'description': 'The Barthel Index will be used to assess functional status. Scores for this assessment tool range from 0 - 100, with a higher number indicating a better functional status.'}, {'measure': 'Functional Status - at inclusion and 30 days', 'timeFrame': '30 days post subject discharge', 'description': 'The Stroke Impact Scale will be used to assess functional status. Scores for this scale range from 0 - 100, with a higher number indicating a better functional status.'}, {'measure': 'Functional Status - at inclusion and 30 days', 'timeFrame': '30 days post subject discharge', 'description': 'The EQ-VAS will be used to assess functional status. Participants rate their health from 0 (worst imaginable health) to 100 (best imaginable health).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Intraventricular Hemorrhage', 'Subarachnoid Hemorrhage', 'Subdural Hematoma', 'Ventriculitis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD).\n\nSubjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years of age\n2. Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis\n3. Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis\n4. Signed informed consent obtained by subject or Legally Authorized Representative\n\nExclusion Criteria:\n\n1. Subject has fixed and dilated pupils\n2. Pregnant women\n3. Presence of Moyamoya\n4. History or presence of clotting disorder.\n5. Platelet count less than 100,000, INR greater than 1.4'}, 'identificationModule': {'nctId': 'NCT05649904', 'acronym': 'AFFECT', 'briefTitle': 'AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection', 'orgStudyIdInfo': {'id': '2022H0197'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IRRAflow with Active Fluid Exchange System (IRRAflow)', 'description': 'Subjects may be randomized to receive the IRRAflow with Active Fluid Exchange System (intervention) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.', 'interventionNames': ['Device: IRRAflow with Active Fluid Exchange System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'External Ventricular Drainage (EVD)', 'description': 'Subjects may be randomized to receive an External Ventricular Drain (control) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.', 'interventionNames': ['Device: External Ventricular Drain']}], 'interventions': [{'name': 'IRRAflow with Active Fluid Exchange System', 'type': 'DEVICE', 'otherNames': ['IRRAflow'], 'description': 'IRRAflow® Active Fluid Exchange System is an intracranial drainage system intended for use by professional medical hospital personnel, trained and experienced in neurosurgical medical care.\n\nThe intracranial pressure is kept at a safe level by draining excessive intracranial fluid. The system incorporates an irrigation support mechanism, used to irrigate the system in a controlled, programmed manner to minimize catheter occlusion. Additionally, a manual bolus can be given to facilitate keeping the catheter clear of occlusion or to clear the catheter of occlusion if one is present. This mechanism works by producing a bolus pulse using short periods of high flow (i.e. flow pulses).', 'armGroupLabels': ['IRRAflow with Active Fluid Exchange System (IRRAflow)']}, {'name': 'External Ventricular Drain', 'type': 'DEVICE', 'otherNames': ['EVD'], 'description': 'The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.', 'armGroupLabels': ['External Ventricular Drainage (EVD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edouard Belizaire', 'role': 'CONTACT', 'email': 'edouard.belizaire@osumc.edu'}, {'name': 'Uchechi Okafor', 'role': 'CONTACT', 'email': 'Uchechi.Okafor@osumc.edu'}, {'name': 'Patrick Youssef', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shahid Nimjee', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ciaran Powers', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Edouard Beliaire', 'role': 'CONTACT', 'email': 'edouard.belizaire@osumc.edu', 'phone': '6143666936'}, {'name': 'Patrick Youssef, MD', 'role': 'CONTACT', 'email': 'patrick.youssef@osumc.edu', 'phone': '6143666590'}], 'overallOfficials': [{'name': 'Patrick Youssef, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'IRRAS', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor of Neurological Surgery', 'investigatorFullName': 'Patrick Youssef', 'investigatorAffiliation': 'Ohio State University'}}}}