Postoperative Balloninflation After Evacuation of cSDH (BANISH)

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Procedure: Balloninflation

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt Niederrad, Hessen, Germany, 60528
      • Recruiting
      • University Hospital
      • Contact: Sae-Yeon Won, MD; Phone Number: 06963015295; Email: sae-yeon.won@kgu.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence Rate	Reoperation of chronic subdural hematoma	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): August 30, 2021
• Study Completion (ANTICIPATED): February 28, 2022

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (ACTUAL): August 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Outcome; Recurrence rate of cSDH
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: BANISH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No