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Postoperative Balloninflation After Evacuation of cSDH

NCT ID: NCT04060186

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Subdural Hematoma

Keywords

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Recurrence rate of cSDH Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Balloninflation Group

Patient who will perform a balloninflation after operation

Group Type ACTIVE_COMPARATOR

Balloninflation

Intervention Type PROCEDURE

Patient will inflate into a ballon made by a handglove 2-3times/h from 8:00-20:00 after evacuation of chronic subdural hematoma.

Conservative Group

Patient without performing a balloninflation

Group Type SHAM_COMPARATOR

Balloninflation

Intervention Type PROCEDURE

Patient will inflate into a ballon made by a handglove 2-3times/h from 8:00-20:00 after evacuation of chronic subdural hematoma.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marina Heibel

Study Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital

Niederrad, Hesse, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sae-Yeon Won, MD

Role: CONTACT

Phone: 06963014291

Email: [email protected]

Anne Sicking

Role: CONTACT

Phone: 06963014291

Email: [email protected]

Facility Contacts

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Sae-Yeon Won, MD

Role: primary

Other Identifiers

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BANISH

Identifier Type: -

Identifier Source: org_study_id