Postoperative Balloninflation After Evacuation of cSDH

Chronic Subdural Hematoma Clinical Trial

— BANISH  

Official title:

Balloninflation After Evacuation of Chronical Subdural Haematoma for Reduction of Hematoma Recurrrence: Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04060186
• Other study ID #: BANISH
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: December 2019
• Source: Johann Wolfgang Goethe University Hospital
• Contact: Sae-Yeon Won, MD
• Phone: 06963014291
• Email: sae-yeon.won[@]kgu.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital	Frankfurt Niederrad	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Rate	Reoperation of chronic subdural hematoma	3 Months
Secondary	Neurological Functional Outcome	Modified Rankin Scale (0-6) 0 - No symptoms.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead. mRS0-3: favorable Outcome mRS: 4-6: unfavorable Outcome	6 Months