Postoperative Balloninflation After Evacuation of cSDH
BANISH
Balloninflation After Evacuation of Chronical Subdural Haematoma for Reduction of Hematoma Recurrrence: Randomized Controlled Study
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 19, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedDecember 20, 2019
December 1, 2019
1.7 years
August 6, 2019
December 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence Rate
Reoperation of chronic subdural hematoma
3 Months
Secondary Outcomes (1)
Neurological Functional Outcome
6 Months
Study Arms (2)
Balloninflation Group
ACTIVE COMPARATORPatient who will perform a balloninflation after operation
Conservative Group
SHAM COMPARATORPatient without performing a balloninflation
Interventions
Patient will inflate into a ballon made by a handglove 2-3times/h from 8:00-20:00 after evacuation of chronic subdural hematoma.
Eligibility Criteria
You may qualify if:
- age over 18 years
- surgically treated cSDH
- patients with an operatively implanted subdural drainage
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Niederrad, Hesse, 60528, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Nurse
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 19, 2019
Study Start
January 1, 2020
Primary Completion
August 30, 2021
Study Completion
February 28, 2022
Last Updated
December 20, 2019
Record last verified: 2019-12