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

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ClinicalTrials.gov Identifier: NCT03788005
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Sérgio Sousa, Centro Hospitalar do Porto

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.

Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Procedure: Early mobilization Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas: GET-UP Randomized Prospective Trial
Actual Study Start Date : April 7, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : September 1, 2021

Arm Intervention/treatment
Active Comparator: Intervention group

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

No Intervention: Control Group
Bed rest with head of bed at 0 degrees for 48h. Subdural drains will be removed past 48 hours of surgery.



Primary Outcome Measures :
  1. Medical Complications [ Time Frame: From date of randomization until 3 months post-randomization ]
    Infections, venous thromboembolism, seizures


Secondary Outcome Measures :
  1. Recurrence [ Time Frame: At 3 months follow-up ]
    Recurrence of a chronic subdural hematoma if surgical intervention is required

  2. Post-operative Modified Rankin scale [ Time Frame: At 3 months follow-up ]
    Modified Rankin Scale from 0 (free of symptoms) to a maximum of 6 (dead)

  3. Survival [ Time Frame: At 3 months follow-up ]
    Survival

  4. Length of hospital stay [ Time Frame: From date of randomization until clinical discharge up to 36 months ]
    Time to clinical discharge

  5. Post-operative GOS-E scale [ Time Frame: At 3 months follow-up ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788005


Contacts
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Contact: Sérgio Sousa, MD +351918611865 sergioalvesdesousa7@gmail.com

Locations
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Portugal
Centro Hospitalar Universitário do Porto Recruiting
Porto, Portugal, 4000
Contact: Sérgio Sousa, MD    00351918611865    sergioalvesdesousa7@gmail.com   
Principal Investigator: Sérgio Sousa, MD         
Principal Investigator: Vasco Pinto, MD         
Principal Investigator: Filipe Vaz da Silva, MD         
Sponsors and Collaborators
Centro Hospitalar do Porto
Investigators
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Principal Investigator: Sérgio Sousa, MD Centro Hospitalar do Porto

Publications:
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Responsible Party: Sérgio Sousa, Principal Investigator, Centro Hospitalar do Porto
ClinicalTrials.gov Identifier: NCT03788005     History of Changes
Other Study ID Numbers: 2018-176 (151-DEFI/150-CES)
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sérgio Sousa, Centro Hospitalar do Porto:
Chronic Subdural Hematoma
Bed rest
Early mobilization
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
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
Wounds and Injuries