Chronic Subdural Hematoma
Conditions
Keywords
Recurrence rate of cSDH, Outcome
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.
Interventions
PROCEDUREBalloninflation
Patient will inflate into a ballon made by a handglove 2-3times/h from 8:00-20:00 after evacuation of chronic subdural hematoma.
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate | 3 Months | Reoperation of chronic subdural hematoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological Functional Outcome | 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 |
Countries
Germany
Contacts
Primary ContactSae-Yeon Won, MD
Backup ContactAnne Sicking
Outcome results
None listed