Chronic Subdural HematomaGET-UPNCT03788005
GET-UP Trial: Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas
A study testing Early mobilization in people with Chronic Subdural Hematoma, run by Centro Hospitalar do Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Early mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 sitePortugal
- Study dates
- 7 Apr 2019to 5 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgically drained chronic subdural hematomas (Burr hole craniostomy)
- > or equal to 18 years old
Who cannot join
- Previous neurosurgery
- Surgery for another pathology performed at the same time
- > 6h sedation post-surgery
- Any previous condition that makes early mobilization impossible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Early mobilization
- Keywords
- Chronic Subdural Hematoma, Bed rest, Early mobilization
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilizationProcedure or surgery
Early mobilization as soon as possible and within a maximum of 12 hours following burr hole craniostomy for chronic subdural hematomas.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Complications
Infections, venous thromboembolism, seizures
Measured: From date of randomization until 3 months post-randomization
Secondary outcomes (5)
Recurrence
Recurrence of a chronic subdural hematoma if surgical intervention is required
Measured: At 3 months follow-up
Post-operative Modified Rankin scale
Modified Rankin Scale from 0 (free of symptoms) to a maximum of 6 (dead)
Measured: At 3 months follow-up
Survival
Survival
Measured: At 3 months follow-up
Length of hospital stay
Time to clinical discharge
Measured: From date of randomization until clinical discharge up to 36 months
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)
Measured: At 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start7 Apr 2019
- Primary completion5 Aug 2021
- Study completion5 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sérgio Sousa, Centro Hospitalar do Porto
- Investigators
- Sérgio Sousa, MD, Principal investigator, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788005
- Sponsor's protocol ID
- 2018-176 (151-DEFI/150-CES)
- Acronym
- GET-UP
- Status last verified
- Aug 2021
- First submitted
- 19 Dec 2018
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20336332Brennan 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.
PubMed 27834599Pinto 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.
PubMed 37948693Sousa 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.
PubMed 36933251
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas: GET-UP Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT03788005
- Acronym / sponsor ID
- GET-UP / 2018-176 (151-DEFI/150-CES)
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic Subdural Hematoma, Bed rest, Early mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Centro Hospitalar do PortoUniversity, hospital or other
- Study start
- 7 Apr 2019 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2022 (estimated)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Procedure: Early mobilizationEarly 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgically drained chronic subdural hematomas (Burr hole craniostomy)
- > or equal to 18 years old
Key exclusion criteria (4 listed)
- Previous neurosurgery
- Surgery for another pathology performed at the same time
- > 6h sedation post-surgery
- Any previous condition that makes early mobilization impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early mobilizationEarly mobilization as soon as possible and within a maximum of 12 hours following burr hole craniostomy for chronic subdural hematomas. | Procedure or surgery | Intervention group |
Primary outcome
Medical Complications
Time frame: From date of randomization until 3 months post-randomization
Infections, venous thromboembolism, seizures
5 secondary outcomes
Recurrence
Time frame: At 3 months follow-up
Post-operative Modified Rankin scale
Time frame: At 3 months follow-up
Survival
Time frame: At 3 months follow-up
Length of hospital stay
Time frame: From date of randomization until clinical discharge up to 36 months
Post-operative GOS-E scale
Time frame: At 3 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Background: PubMed 20336332Kurabe 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.
- Background: PubMed 27834599Brennan 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.
- Derived from this study: PubMed 37948693Pinto 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.
- Derived from this study: PubMed 36933251Sousa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sérgio Sousa, MD principal investigator
Centro Hospitalar do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilization in people with Chronic Subdural Hematoma, run by Centro Hospitalar do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Complications (time frame: From date of randomization until 3 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03788005, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.