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

NCT03788005 | Unknown DMC

• 1 other identifier: 2018-176 (151-DEFI/150-CES)
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematoma

Keywords

Chronic Subdural Hematoma; Bed rest; Early mobilization

Outcome Measures

Primary Outcomes (1)

• Medical Complications

  Infections, venous thromboembolism, seizures

  From date of randomization until 3 months post-randomization

Secondary Outcomes (5)

• Recurrence

  At 3 months follow-up

• Post-operative Modified Rankin scale

  At 3 months follow-up

• Survival

  At 3 months follow-up

• Length of hospital stay

  From date of randomization until clinical discharge up to 36 months

• Post-operative GOS-E scale

  At 3 months follow-up

Study Arms (2)

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.

Procedure: Early mobilization

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.

Interventions

Early mobilization PROCEDURE

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgically drained chronic subdural hematomas (Burr hole craniostomy)
• \> or equal to 18 years old

You may not qualify if:

• Previous neurosurgery
• Surgery for another pathology performed at the same time
• \> 6h sedation post-surgery
• Any previous condition that makes early mobilization impossible

Sponsors & Collaborators

• Centro Hospitalar do Porto: lead

Study Sites (1)

Centro Hospitalar Universitário do Porto

Porto, 4000, Portugal

Location

Related Publications (4)

• 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: 20336332 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.

  PMID: 27834599 BACKGROUND

• 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: 37948693 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.

  PMID: 36933251 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Sérgio Sousa, MD

  Centro Hospitalar do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 27, 2018
• Study Start: April 7, 2019
• Primary Completion: August 5, 2021
• Study Completion: August 5, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

PT (1)