Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-18 @ 2:27 AM
Study NCT ID:
NCT03788005
Status:
UNKNOWN
Last Update Posted:
2021-08-24
First Post:
2018-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GET-UP Trial: Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004434', 'term': 'Early Ambulation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-08-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-21', 'studyFirstSubmitDate': '2018-12-19', 'studyFirstSubmitQcDate': '2018-12-25', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical Complications', 'timeFrame': 'From date of randomization until 3 months post-randomization', 'description': 'Infections, venous thromboembolism, seizures'}], 'secondaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': 'At 3 months follow-up', 'description': 'Recurrence of a chronic subdural hematoma if surgical intervention is required'}, {'measure': 'Post-operative Modified Rankin scale', 'timeFrame': 'At 3 months follow-up', 'description': 'Modified Rankin Scale from 0 (free of symptoms) to a maximum of 6 (dead)'}, {'measure': 'Survival', 'timeFrame': 'At 3 months follow-up', 'description': 'Survival'}, {'measure': 'Length of hospital stay', 'timeFrame': 'From date of randomization until clinical discharge up to 36 months', 'description': 'Time to clinical discharge'}, {'measure': 'Post-operative GOS-E scale', 'timeFrame': 'At 3 months follow-up', 'description': 'GOS-E scale from 1 (dead) to a maximum of 8 (upper good recovery - resumption of normal life within the capacity work even if pre-injury status has not been achieved; any existing deficits are not disabling)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Subdural Hematoma', 'Bed rest', 'Early mobilization'], 'conditions': ['Chronic Subdural Hematoma']}, 'referencesModule': {'references': [{'pmid': '20336332', 'type': 'BACKGROUND', 'citation': 'Kurabe S, Ozawa T, Watanabe T, Aiba T. Efficacy and safety of postoperative early mobilization for chronic subdural hematoma in elderly patients. Acta Neurochir (Wien). 2010 Jul;152(7):1171-4. doi: 10.1007/s00701-010-0627-4. Epub 2010 Mar 25.'}, {'pmid': '27834599', 'type': 'BACKGROUND', 'citation': 'Brennan PM, Kolias AG, Joannides AJ, Shapey J, Marcus HJ, Gregson BA, Grover PJ, Hutchinson PJ, Coulter IC; British Neurosurgical Trainee Research Collaborative. The management and outcome for patients with chronic subdural hematoma: a prospective, multicenter, observational cohort study in the United Kingdom. J Neurosurg. 2017 Oct;127(4):732-739. doi: 10.3171/2016.8.JNS16134. Epub 2016 Nov 11.'}, {'pmid': '37948693', 'type': 'DERIVED', 'citation': 'Pinto V, Sousa SA, Vaz da Silva F, Ribeiro da Costa T, Fernandes AP, Batata R, Noronha C, Monteiro Silva J, Ferreira S, Sobral S, Alves C, Rangel R, Calheiros A; GET-UP Trial Collaborators. GET-UP Trial 1-year results: long-term impact of an early mobilization protocol on functional performance after surgery for chronic subdural hematoma. J Neurosurg. 2023 Nov 10;140(5):1434-1441. doi: 10.3171/2023.8.JNS231509. Print 2024 May 1.'}, {'pmid': '36933251', 'type': 'DERIVED', 'citation': 'Sousa S, Pinto V, Vaz da Silva F, Ribeiro da Costa T, Fernandes A, Batata R, Noronha C, Monteiro Silva J, Ferreira S, Sobral S, Alves C, Rangel R, Calheiros A; GET-UP Trial Collaborators. Impact of an early mobilization protocol on the reduction of medical complications after surgery for chronic subdural hematoma: the GET-UP Trial. J Neurosurg. 2023 Mar 17;139(3):854-863. doi: 10.3171/2023.2.JNS222262. Print 2023 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'Compare rates of medical complications, recurrence and outcome in 2 randomized groups of patients with surgical chronic subdural hematomas. The intervention group will be assigned to early mobilization (within 12 hours of the surgical procedure). The control group will be assigned to bed rest for 48 hours.', 'detailedDescription': 'At Centro Hospitalar do Porto it is routinely used burr hole craniostomy with subdural drains and 48 hours of bed rest for the surgical treatment of chronic subdural hematomas. After 48 hours the subdural drains are removed and the patient is allowed to mobilize for the first time.\n\nThe aim of the present study is to conduct a prospective, randomized, controlled trial with an early mobilization protocol vs 48 hours bed rest to determine the best strategy to reduce postoperative complications and improve functional outcomes.\n\nThere will be 2 groups:\n\n* Control group: bed rest 48 hours post-surgery with removal of subdural drains after this period.\n* Intervention group: Early mobilization protocol: as early mobilization as possible, within a maximum of 12 hours following surgery, with progressive autonomization in the ward as tolerated by the patient. Mobilization time will be recorded. At the time of assuming an upright position the drains will be closed and will only be open again when the patient is in supine position (8 hours per day of supine position). Subdural drains will be removed after 48 hours, similar to the practice in the control group.\n\nPrimary End-Point:\n\n• Number of medical complications. Medical complication is defined as any occurrence which merits additional tests or, preferentially, requires any form of medical treatment. This includes respiratory infections, urinary infections, wound infections, meningitis, deep vein thrombosis, pulmonary embolism, cerebral infarction or hemorrhage, syncope, among others.\n\nSecondary End-Points:\n\n* Recurrence rates. A recurrence is defined as any chronic subdural hematoma ipsilateral to that of the original hematoma if a surgical strategy needs to be pursued.\n* Functional status (using both GOS-E and mRS). Timeframes considered will be pre-operative functional status, functional status at discharge, functional status at 3 months post-operative.\n* Mortality rates.\n* Recurrence free survival.\n* Time to discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgically drained chronic subdural hematomas (Burr hole craniostomy)\n* \\> or equal to 18 years old\n\nExclusion Criteria:\n\n* Previous neurosurgery\n* Surgery for another pathology performed at the same time\n* \\> 6h sedation post-surgery\n* Any previous condition that makes early mobilization impossible'}, 'identificationModule': {'nctId': 'NCT03788005', 'acronym': 'GET-UP', 'briefTitle': 'GET-UP Trial: Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar do Porto'}, 'officialTitle': 'Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas: GET-UP Randomized Prospective Trial', 'orgStudyIdInfo': {'id': '2018-176 (151-DEFI/150-CES)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'Early mobilization as soon as possible, within a maximum of 12 hours post-surgery.\n\nSubdural drains will be closed when the patient is allowed to mobilize and will be open during a nocturnal period of 8 hours. Subdural drains will be removed past 48 hours of surgery.', 'interventionNames': ['Procedure: Early mobilization']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Bed rest with head of bed at 0 degrees for 48h. Subdural drains will be removed past 48 hours of surgery.'}], 'interventions': [{'name': 'Early mobilization', 'type': 'PROCEDURE', 'description': 'Early mobilization as soon as possible and within a maximum of 12 hours following burr hole craniostomy for chronic subdural hematomas.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Centro Hospitalar Universitário do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'overallOfficials': [{'name': 'Sérgio Sousa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Hospitalar do Porto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar do Porto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sérgio Sousa', 'investigatorAffiliation': 'Centro Hospitalar do Porto'}}}}