Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 4:09 PM
Study NCT ID:
NCT04203550
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2019-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-26', 'size': 1883672, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-06T02:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Due to the nature of the treatment, it is not possible to blind the surgeon and OR staff from the treatment allocation. Measures to minimize bias include:\n\n* The patient will not be informed of treatment allocation\n* Treatment allocation will not be documented in medical records i.e. all the personnel participating in patient care after operation will be blinded to allocation\n* The study group members collecting postoperative data and performing the statistical analyses will be blinded to treatment arm until the analyses are finished.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, controlled, parallel group non-inferiority trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 587}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-18', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of re-operations of ipsilateral chronic subdural hematoma', 'timeFrame': 'From operation up to 6 months after postoperatively', 'description': 'Rate of reoperations between groups'}], 'secondaryOutcomes': [{'measure': 'Change of Modified Rankin Scale (MRS) from baseline to 6 months after operation', 'timeFrame': 'At baseline, and at 2 and 6 months after operation', 'description': 'Modified Rankin scale ranges from 1 to 6, where 1 indicates normal daily functionality and 6 indicates death'}, {'measure': 'Rate of mortality between intervention groups', 'timeFrame': 'From operation up to 6 months postoperatively', 'description': 'Rate of mortality between intervention groups'}, {'measure': 'Duration of the operation between groups', 'timeFrame': 'Intraoperative measure', 'description': 'Time (minutes) used to complete the operation, from incision to last suture'}, {'measure': 'Hospital length of stay between groups', 'timeFrame': 'From operation up to six months', 'description': 'The duration of the stay in hospital (days)'}, {'measure': 'Change in the volume of CSDH in the CT or MRI image between baseline and 2 months post-operatively', 'timeFrame': 'Immediate preoperative and 2 months postoperatively', 'description': 'The volume of CSDH will be measured from preoperative CT or MRI and at 2 months after operation CT or MRI'}, {'measure': 'Rate of complications and adverse events within 6 months', 'timeFrame': 'within 6 months after operation', 'description': 'Rate of complication rate between groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Subdural hematoma', 'Surgical evacuation', 'Recurrence', 'Irrigation fluid'], 'conditions': ['Chronic Subdural Hematoma']}, 'referencesModule': {'references': [{'pmid': '41326886', 'type': 'DERIVED', 'citation': 'Tommiska P, Knuutinen O, Lonnrot K, Luoto T, Leinonen V, Koivisto T, Tetri S, Posti JP, Raj R; FINISH study group. Mortality and causes of death after surgery for chronic subdural hematoma: a post hoc study of the FINISH randomized trial. Acta Neurochir (Wien). 2025 Dec 1;167(1):310. doi: 10.1007/s00701-025-06728-9.'}, {'pmid': '40024327', 'type': 'DERIVED', 'citation': 'Knuutinen O, Maatta J, Kovalainen A, Pohjola A, Tommiska P, Raj R; FINISH study group. Surgical Delay and Functional Outcome After Surgery for Chronic Subdural Hematoma. World Neurosurg. 2025 May;197:123843. doi: 10.1016/j.wneu.2025.123843. Epub 2025 Feb 28.'}, {'pmid': '39815109', 'type': 'DERIVED', 'citation': 'Tommiska P, Knuutinen O, Lonnrot K, Kivisaari R, Raj R; FINISH study group. Association between postoperative thromboembolic and hemorrhagic complications and clinical outcomes after surgery for chronic subdural hematoma in patients with anticoagulation therapy for atrial fibrillation. Acta Neurochir (Wien). 2025 Jan 16;167(1):17. doi: 10.1007/s00701-024-06417-z.'}, {'pmid': '38852600', 'type': 'DERIVED', 'citation': 'Raj R, Tommiska P, Koivisto T, Leinonen V, Danner N, Posti JP, Laukka D, Luoto T, Rauhala M, Tetri S, Korhonen TK, Satopaa J, Kivisaari R, Luostarinen T, Schwartz C, Czuba T, Taimela S, Lonnrot K, Jarvinen TLN; Finnish study of intraoperative irrigation versus drain alone after evacuation of CSDH (FINISH) study group. Burr-hole drainage with or without irrigation for chronic subdural haematoma (FINISH): a Finnish, nationwide, parallel-group, multicentre, randomised, controlled, non-inferiority trial. Lancet. 2024 Jun 29;403(10446):2798-2806. doi: 10.1016/S0140-6736(24)00686-X. Epub 2024 Jun 6.'}, {'pmid': '32565480', 'type': 'DERIVED', 'citation': 'Tommiska P, Raj R, Schwartz C, Kivisaari R, Luostarinen T, Satopaa J, Taimela S, Jarvinen T, Ranstam J, Frantzen J, Posti J, Luoto TM, Leinonen V, Tetri S, Koivisto T, Lonnrot K. Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial. BMJ Open. 2020 Jun 21;10(6):e038275. doi: 10.1136/bmjopen-2020-038275.'}]}, 'descriptionModule': {'briefSummary': 'FINISH-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (CSDH) with intraoperative irrigation (IR) and evacuation of CSDH without irrigation (N-IR).', 'detailedDescription': 'FINISH-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (CSDH) with intraoperative irrigation (IR) and evacuation of CSDH without irrigation (N-IR). In both groups, a passive subdural drain is used for 48 hours as a standard of treatment. The study will be conducted in all five neurosurgical departments in Finland. To determine whether operation without irrigation results in non-inferior outcome to operation with irrigation, we will randomize 426 patients into two groups and follow them up for 6 months using recurrence rates as the primary outcome. Secondary outcomes in our study include mortality, neurological outcome and complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation\n\n o Predominantly hypodense or isodense on imaging (CT/MRI).\n* Clinical symptoms correlating with the CSDH\n* Patients with bilaterally operated CSDHs will be treated with the same protocol on both sides and analyzed as a single study participant\n\nExclusion Criteria:\n\n* CSDH requiring surgical treatment other that burr-hole evacuation (e.g. craniotomy)\n* CSDH in a patient who has a cerebrospinal fluid shunt\n* Patients who have undergone any intracranial surgery before\n* Comatose patients (GCS 8 or lower) with absent motor responses to painful stimuli; decerebrate or decorticate posturing\n* Patient's postoperative cooperation is suspected to be insufficient for drain usage, i.e. disoriented or semiconscious patient\n* Patient has a hematogenic malignancy that has obtained active treatment within the previous five years\n* Patient has a central nervous system tumor or malignancy\n* Patient has acute infection with fever and requires antibiotic treatment at the moment\n* Patient has a high risk of life-threatening thrombosis (e.g. recent coronary stent, recent pulmonary embolism, low cardiac valve replacement) and discontinuation of antithrombotic medication is not recommended"}, 'identificationModule': {'nctId': 'NCT04203550', 'acronym': 'FINISH', 'briefTitle': 'The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH)', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH): a Study Protocol for a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '3035/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Irrigation group (IR)', 'description': 'A burr-hole craniostomy is performed and the dura is opened sharply and 10 ml of subdural exudate is aspired with blunt aspiration needle for a CSDH sample to be stored in -70℃ to be used for later analysis. Subdural space is irrigated by repeated rinsing with body temperature saline solution with a syringe and blunt needle until surgeon considers exudate to be clear. Minimum volume of irrigation will be 200 ml per operated side. The subdural drain is inserted 3-5 cm underneath the skull and parallel to it. The total volume of irrigation as well as the duration of operation is recorded.', 'interventionNames': ['Procedure: Intraoperative irrigation']}, {'type': 'EXPERIMENTAL', 'label': 'No-Irrigation group (N-IR)', 'description': 'A burr-hole craniostomy is performed and a small incision to the dura is made and 10 ml of subdural exudate is aspired with blunt aspiration needle for a CSDH sample to be stored in -70℃ to be used for later analysis. The subdural drain is inserted approximately 3-5 cm underneath the skull and parallel to it. The duration of operation is recorded.', 'interventionNames': ['Procedure: No irrigation']}], 'interventions': [{'name': 'Intraoperative irrigation', 'type': 'PROCEDURE', 'description': 'Operation with irrigation', 'armGroupLabels': ['Irrigation group (IR)']}, {'name': 'No irrigation', 'type': 'PROCEDURE', 'description': 'Operation without irrigation', 'armGroupLabels': ['No-Irrigation group (N-IR)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Kimmo Lönnrot, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Study protocol and Statistical Analysis Plan (SAP) will be published after the study has started. Other document will be available as study proceeds and after study is completed.', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) is available upon request when General Data Protection Regulation (GDPR) and guiding legislation regulations are fulfilled.', 'accessCriteria': 'Data access request will be reviewed by FINISH-trial steering group. Requestors will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, {'name': 'Oulu University Hospital', 'class': 'OTHER'}, {'name': 'Tampere University Hospital', 'class': 'OTHER'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kimmo Lonnrot', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}