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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Subdural Hematoma||Procedure: Early mobilization||Not Applicable|
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.
• 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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Medical Complications [ Time Frame: From date of randomization until 3 months post-randomization ]Infections, venous thromboembolism, seizures
- Recurrence [ Time Frame: At 3 months follow-up ]Recurrence of a chronic subdural hematoma if surgical intervention is required
- 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)
- Survival [ Time Frame: At 3 months follow-up ]Survival
- Length of hospital stay [ Time Frame: From date of randomization until clinical discharge up to 36 months ]Time to clinical discharge
- 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)
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
|Contact: Sérgio Sousa, MDfirstname.lastname@example.org|
|Centro Hospitalar Universitário do Porto||Recruiting|
|Porto, Portugal, 4000|
|Contact: Sérgio Sousa, MD 00351918611865 email@example.com|
|Principal Investigator: Sérgio Sousa, MD|
|Principal Investigator: Vasco Pinto, MD|
|Principal Investigator: Filipe Vaz da Silva, MD|
|Principal Investigator:||Sérgio Sousa, MD||Centro Hospitalar do Porto|