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Postoperative Balloninflation After Evacuation of cSDH (BANISH)

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ClinicalTrials.gov Identifier: NCT04060186
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Marina Heibel, Johann Wolfgang Goethe University Hospital

Brief Summary:
In this prospective, randomized, multicenter trial shall patients with chronic subdural hematoma (cSDH) recruited, who were surgically treated. Initially, we would divide the patients randomized into two groups: Patients with supervised blow-maneuver and without. After surgical treatment of cSDH with insertion of a subdural drain, one group would perform a supervised blow maneuver ("Valsalva maneuver") every hour for five minutes from 10:00 to 20:00. In the other group, the standard care would be performed. The subdural drain would be explanted 2days after operation and a postoperative CT scan would routinely be performed. After hospital discharge, the patient would be rechecked in an ambulant setting and would receive CT scan as clinical standard. Recurrence of hematoma is defined as recurrent hematoma which should be reoperated. After 3 and 6 months we would evaluate the outcome of patients.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Balloninflation After Evacuation of Chronical Subdural Haematoma for Reduction of Hematoma Recurrrence: Randomized Controlled Study
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : February 28, 2022

Arm Intervention/treatment
Active Comparator: Balloninflation Group
Patient who will perform a balloninflation after operation
Procedure: Balloninflation
Patient will inflate into a ballon made by a handglove 2-3times/h from 8:00-20:00 after evacuation of chronic subdural hematoma.

Sham Comparator: Conservative Group
Patient without performing a balloninflation
Procedure: Balloninflation
Patient will inflate into a ballon made by a handglove 2-3times/h from 8:00-20:00 after evacuation of chronic subdural hematoma.




Primary Outcome Measures :
  1. Recurrence Rate [ Time Frame: 3 Months ]
    Reoperation of chronic subdural hematoma


Secondary Outcome Measures :
  1. Neurological Functional Outcome [ Time Frame: 6 Months ]

    Modified Rankin Scale (0-6) 0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead. mRS0-3: favorable Outcome mRS: 4-6: unfavorable Outcome



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age over 18 years
  • surgically treated cSDH
  • patients with an operatively implanted subdural drainage

Exclusion Criteria:

  • age under 18 years
  • Admission in critical clinical state, e.g. already to light unresponsive pupils for about 2 hours
  • conservative treatment of cSDH
  • patients without an operatively implanted subdural drainage
  • patient cannot be consented
  • participation in other clinical trials

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): NCT04060186


Contacts
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Contact: Sae-Yeon Won, MD 06963014291 sae-yeon.won@kgu.de
Contact: Anne Sicking 06963014291 anne.sicking@kgu.de

Locations
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Germany
University Hospital Recruiting
Frankfurt Niederrad, Hessen, Germany, 60528
Contact: Sae-Yeon Won, MD    06963015295    sae-yeon.won@kgu.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital

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Responsible Party: Marina Heibel, Study Nurse, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT04060186     History of Changes
Other Study ID Numbers: BANISH
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019

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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 Marina Heibel, Johann Wolfgang Goethe University Hospital:
Recurrence rate of cSDH
Outcome
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