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

August 21, 2021 updated by: Sérgio Sousa, Centro Hospitalar do Porto

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4000
        • Centro Hospitalar Universitario do Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: At 3 months follow-up
Recurrence of a chronic subdural hematoma if surgical intervention is required
At 3 months follow-up
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)
At 3 months follow-up
Survival
Time Frame: At 3 months follow-up
Survival
At 3 months follow-up
Length of hospital stay
Time Frame: From date of randomization until clinical discharge up to 36 months
Time to clinical discharge
From date of randomization until clinical discharge up to 36 months
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)
At 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar do Porto

Investigators

  • Principal Investigator: Sérgio Sousa, MD, Centro Hospitalar do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2019

Primary Completion (Actual)

August 5, 2021

Study Completion (Anticipated)

August 5, 2022

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

December 25, 2018

First Posted (Actual)

December 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 21, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-176 (151-DEFI/150-CES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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