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

Chronic Subdural Hematoma Clinical Trial

— GET-UP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03788005
• Other study ID #: 2018-176 (151-DEFI/150-CES)
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 7, 2019
• Est. completion date: August 5, 2022

Study information

• Verified date: August 2021
• Source: Centro Hospitalar do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 208
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• Early mobilization
Early mobilization as soon as possible and within a maximum of 12 hours following burr hole craniostomy for chronic subdural hematomas.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Universitário do Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical Complications	Infections, venous thromboembolism, seizures	From date of randomization until 3 months post-randomization
Secondary	Recurrence	Recurrence of a chronic subdural hematoma if surgical intervention is required	At 3 months follow-up
Secondary	Post-operative Modified Rankin scale	Modified Rankin Scale from 0 (free of symptoms) to a maximum of 6 (dead)	At 3 months follow-up
Secondary	Survival	Survival	At 3 months follow-up
Secondary	Length of hospital stay	Time to clinical discharge	From date of randomization until clinical discharge up to 36 months
Secondary	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