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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.
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.
The 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.
There will be 2 groups:
Primary End-Point:
• 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.
Secondary End-Points:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Early mobilization as soon as possible, within a maximum of 12 hours post-surgery. Subdural 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. |
|
| Control Group | No Intervention | Bed rest with head of bed at 0 degrees for 48h. Subdural drains will be removed past 48 hours of surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early mobilization | Procedure | Early mobilization as soon as possible and within a maximum of 12 hours following burr hole craniostomy for chronic subdural hematomas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medical Complications | Infections, venous thromboembolism, seizures | From date of randomization until 3 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | Recurrence of a chronic subdural hematoma if surgical intervention is required | At 3 months follow-up |
| Post-operative Modified Rankin scale | Modified Rankin Scale from 0 (free of symptoms) to a maximum of 6 (dead) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sérgio Sousa, MD | Centro Hospitalar do Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Universitário do Porto | Porto | 4000 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20336332 | Background | 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. | |
| 27834599 | Background | 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. |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D004434 | Early Ambulation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| At 3 months follow-up |
| Survival | Survival | At 3 months follow-up |
| Length of hospital stay | Time to clinical discharge | From date of randomization until clinical discharge up to 36 months |
| Post-operative GOS-E scale | 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) | At 3 months follow-up |
| 37948693 | Derived | 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. |
| 36933251 | Derived | 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. |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
| D013812 |
| Therapeutics |