NCT01869855

Brief Summary

The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage. We hypothesize that patients treated with a subperiosteal drainage do not show higher recurrence rates than those treated with a subdural drainage, and suffer less complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

3.8 years

First QC Date

June 2, 2013

Last Update Submit

June 24, 2017

Conditions

Chronic Subdural Hematoma

Keywords

chronic subdural hematomatraumatic brain injuryburr hole trepanationdrainage after evacuation of chronic subdural hematomaintracranial bleed

Outcome Measures

Primary Outcomes (1)

  • Recurrence Rate

    within the first 12 months postoiperatively

Secondary Outcomes (5)

  • Complication rate (Morbidity)

    within the first 12 months postoperatively

  • Mortality

    within the first 12 months postoperatively

  • Outcome: Markwalder Score

    within the first 12 months postoperatively

  • Outcome: modified Ranking Score

    within the first 12 months postoperatively

  • Outcome: Glasgow Outcome Score

    within the first 12 months postoperatively

Study Arms (2)

110 patients with cSDH assigned to subdural drainage

ACTIVE COMPARATOR

Randomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study.

Procedure: Subdural Drainage

110 patients with cSDH assigned to subperiosteal drainage

ACTIVE COMPARATOR

Randomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study.

Procedure: Subperiosteal Drainage

Interventions

Subdural DrainagePROCEDURE
110 patients with cSDH assigned to subdural drainage
Subperiosteal DrainagePROCEDURE
110 patients with cSDH assigned to subperiosteal drainage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma
  • Chronic subdural hematoma verified on cranial CT or MRI

You may not qualify if:

  • The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy)
  • Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt)
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Neurosurgery Kantonsspital Aarau

Aarau, Canton of Aargau, 5000, Switzerland

Location

Neurosurgery University Hospital of Basel

Basel, 4038, Switzerland

Location

Related Publications (1)

  • Soleman J, Lutz K, Schaedelin S, Mariani L, Fandino J. Use of Subperiosteal Drain Versus Subdural Drain in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 Apr 8;5(2):e38. doi: 10.2196/resprot.5339.

    PMID: 27059872DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, ChronicBrain Injuries, TraumaticIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

Hematoma, SubduralIntracranial Hemorrhage, TraumaticCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematomaHemorrhageWounds and InjuriesBrain Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 2, 2013

First Posted

June 5, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

CH(2)