Postoperative Balloninflation After Evacuation of cSDH (BANISH)

Johann Wolfgang Goethe University Hospital

Status: Unknown

Conditions: Chronic Subdural Hematoma

Treatments: Procedure: Balloninflation

Study type: Interventional

Funder types: Other

Identifiers

NCT04060186

BANISH

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Balloninflation Group

Active Comparator group

Description:

Patient who will perform a balloninflation after operation

Treatment:

Procedure: Balloninflation

Conservative Group

Sham Comparator group

Description:

Patient without performing a balloninflation

Treatment:

Procedure: Balloninflation