Clinical trial NCT03788005: GET-UP Trial: Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas
Official title: Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas: GET-UP Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: Chronic Subdural Hematoma
Bed rest
Early mobilization
Lead sponsor: Centro Hospitalar do Porto
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Medical Complications
timeFrame: From date of randomization until 3 months post-randomization
Secondary outcomes:
measure: Recurrence
timeFrame: At 3 months follow-up
measure: Post-operative Modified Rankin scale
timeFrame: At 3 months follow-up
measure: Survival
timeFrame: At 3 months follow-up
measure: Length of hospital stay
timeFrame: From date of randomization until clinical discharge up to 36 months
measure: Post-operative GOS-E scale
timeFrame: At 3 months follow-up
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário do Porto
Study officials:
affiliation: Centro Hospitalar do Porto
name: Sérgio Sousa, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.