GET-UP Trial: Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Control group: bed rest 48 hours post-surgery with removal of subdural drains after this period. 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. 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: 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. 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. Mortality rates. Recurrence free survival. Time to discharge.

Official Title
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Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas: GET-UP Randomized Prospective Trial

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Procedure: Early mobilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgically drained chronic subdural hematomas (Burr hole craniostomy) > or equal to 18 years old Exclusion Criteria: Previous neurosurgery Surgery for another pathology performed at the same time > 6h sedation post-surgery Any previous condition that makes early mobilization impossible

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>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. | Procedure: Early mobilization<br>* Early mobilization as soon as possible and within a maximum of 12 hours following burr hole craniostomy for chronic subdural hematomas.<br>|
| No Intervention: Control Group<br>Bed rest with head of bed at 0 degrees for 48h. Subdural drains will be removed past 48 hours of surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Complications | Infections, venous thromboembolism, seizures | From date of randomization until 3 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Subdural Hematoma, Bed rest, Early mobilization