<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03788005</url>
  </required_header>
  <id_info>
    <org_study_id>2018-176 (151-DEFI/150-CES)</org_study_id>
    <nct_id>NCT03788005</nct_id>
  </id_info>
  <brief_title>GET-UP Trial: Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas</brief_title>
  <acronym>GET-UP</acronym>
  <official_title>Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas: GET-UP Randomized Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Hospitalar do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Hospitalar do Porto</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare rates of medical complications, recurrence and outcome in 2 randomized groups of&#xD;
      patients with surgical chronic subdural hematomas. The intervention group will be assigned to&#xD;
      early mobilization (within 12 hours of the surgical procedure). The control group will be&#xD;
      assigned to bed rest for 48 hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At Centro Hospitalar do Porto it is routinely used burr hole craniostomy with subdural drains&#xD;
      and 48 hours of bed rest for the surgical treatment of chronic subdural hematomas. After 48&#xD;
      hours the subdural drains are removed and the patient is allowed to mobilize for the first&#xD;
      time.&#xD;
&#xD;
      The aim of the present study is to conduct a prospective, randomized, controlled trial with&#xD;
      an early mobilization protocol vs 48 hours bed rest to determine the best strategy to reduce&#xD;
      postoperative complications and improve functional outcomes.&#xD;
&#xD;
      There will be 2 groups:&#xD;
&#xD;
        -  Control group: bed rest 48 hours post-surgery with removal of subdural drains after this&#xD;
           period.&#xD;
&#xD;
        -  Intervention group: Early mobilization protocol: as early mobilization as possible,&#xD;
           within a maximum of 12 hours following surgery, with progressive autonomization in the&#xD;
           ward as tolerated by the patient. Mobilization time will be recorded. At the time of&#xD;
           assuming an upright position the drains will be closed and will only be open again when&#xD;
           the patient is in supine position (8 hours per day of supine position). Subdural drains&#xD;
           will be removed after 48 hours, similar to the practice in the control group.&#xD;
&#xD;
      Primary End-Point:&#xD;
&#xD;
      • Number of medical complications. Medical complication is defined as any occurrence which&#xD;
      merits additional tests or, preferentially, requires any form of medical treatment. This&#xD;
      includes respiratory infections, urinary infections, wound infections, meningitis, deep vein&#xD;
      thrombosis, pulmonary embolism, cerebral infarction or hemorrhage, syncope, among others.&#xD;
&#xD;
      Secondary End-Points:&#xD;
&#xD;
        -  Recurrence rates. A recurrence is defined as any chronic subdural hematoma ipsilateral&#xD;
           to that of the original hematoma if a surgical strategy needs to be pursued.&#xD;
&#xD;
        -  Functional status (using both GOS-E and mRS). Timeframes considered will be&#xD;
           pre-operative functional status, functional status at discharge, functional status at 3&#xD;
           months post-operative.&#xD;
&#xD;
        -  Mortality rates.&#xD;
&#xD;
        -  Recurrence free survival.&#xD;
&#xD;
        -  Time to discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 7, 2019</start_date>
  <completion_date type="Anticipated">August 5, 2022</completion_date>
  <primary_completion_date type="Actual">August 5, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Medical Complications</measure>
    <time_frame>From date of randomization until 3 months post-randomization</time_frame>
    <description>Infections, venous thromboembolism, seizures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence</measure>
    <time_frame>At 3 months follow-up</time_frame>
    <description>Recurrence of a chronic subdural hematoma if surgical intervention is required</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Modified Rankin scale</measure>
    <time_frame>At 3 months follow-up</time_frame>
    <description>Modified Rankin Scale from 0 (free of symptoms) to a maximum of 6 (dead)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>At 3 months follow-up</time_frame>
    <description>Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>From date of randomization until clinical discharge up to 36 months</time_frame>
    <description>Time to clinical discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative GOS-E scale</measure>
    <time_frame>At 3 months follow-up</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Chronic Subdural Hematoma</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Early mobilization as soon as possible, within a maximum of 12 hours post-surgery.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Bed rest with head of bed at 0 degrees for 48h. Subdural drains will be removed past 48 hours of surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Early mobilization</intervention_name>
    <description>Early mobilization as soon as possible and within a maximum of 12 hours following burr hole craniostomy for chronic subdural hematomas.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgically drained chronic subdural hematomas (Burr hole craniostomy)&#xD;
&#xD;
          -  &gt; or equal to 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous neurosurgery&#xD;
&#xD;
          -  Surgery for another pathology performed at the same time&#xD;
&#xD;
          -  &gt; 6h sedation post-surgery&#xD;
&#xD;
          -  Any previous condition that makes early mobilization impossible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sérgio Sousa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro Hospitalar do Porto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário do Porto</name>
      <address>
        <city>Porto</city>
        <zip>4000</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20336332</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27834599</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>August 21, 2021</last_update_submitted>
  <last_update_submitted_qc>August 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Hospitalar do Porto</investigator_affiliation>
    <investigator_full_name>Sérgio Sousa</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Chronic Subdural Hematoma</keyword>
  <keyword>Bed rest</keyword>
  <keyword>Early mobilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematoma, Subdural</mesh_term>
    <mesh_term>Hematoma, Subdural, Chronic</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03788005
org study id: 2018-176 (151-DEFI/150-CES)
nct id: NCT03788005
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Medical Complications
time frame: From date of randomization until 3 months post-randomization
description: Infections, venous thromboembolism, seizures
measure: Recurrence
time frame: At 3 months follow-up
description: Recurrence of a chronic subdural hematoma if surgical intervention is required
measure: Post-operative Modified Rankin scale
time frame: At 3 months follow-up
description: Modified Rankin Scale from 0 (free of symptoms) to a maximum of 6 (dead)
measure: Survival
time frame: At 3 months follow-up
description: Survival
measure: Length of hospital stay
time frame: From date of randomization until clinical discharge up to 36 months
description: Time to clinical discharge
measure: Post-operative GOS-E scale
time frame: At 3 months follow-up
description: 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)
arm group label: Intervention group
arm group type: Active Comparator
description: 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.
arm group label: Control Group
arm group type: No Intervention
description: Bed rest with head of bed at 0 degrees for 48h. Subdural drains will be removed past 48 hours of surgery.
intervention type: Procedure
intervention name: Early mobilization
description: Early mobilization as soon as possible and within a maximum of 12 hours following burr hole craniostomy for chronic subdural hematomas.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sérgio Sousa, MD
role: Principal Investigator
affiliation: Centro Hospitalar do Porto
facility: 
country: Portugal
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Centro Hospitalar do Porto
investigator full name: Sérgio Sousa
investigator title: Principal Investigator
mesh term: Hematoma, Subdural
mesh term: Hematoma, Subdural, Chronic
mesh term: Hematoma
sharing ipd: Undecided