NCT01930617

Brief Summary

There are numerous reported ways to treat chronic subdural hematomas (CSDH) and practice is still differing considerably between departments. Except for a recent randomized controlled trial (RCT) that found that postoperative subdural drainage was better than no drain, there is no higher level evidence. Another recent RCT did not replicate these findings, but the study was severely underpowered. Aim of this population based study is to compare clinical results (reoperation rates, complications, perioperative death, and survival) between neurosurgical departments treating CSDH with different treatment policies.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,258

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
2 countries

3 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

First Submitted

Initial submission to the registry

August 22, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

August 22, 2013

Last Update Submit

June 24, 2017

Conditions

Hematoma, Subdural, Chronic

Keywords

surgerytrephiningdrainagetherapeutic irrigationsubdural spacepostoperative complicationsmortality

Outcome Measures

Primary Outcomes (1)

  • reoperations

    Number of reoperations (X/N, %) between centers

    1 year

Secondary Outcomes (4)

  • continuous irrigation versus other drainage

    1 year

  • perioperative death

    30 days

  • survival

    3 years

  • surgical complications

    30 days

Study Arms (3)

Trondheim

Burr hole surgery with passive subdural drainage

Procedure: Burr hole surgery with various drainage techniques

Tromsø

Burr hole surgery with continuous irrigation

Procedure: Burr hole surgery with various drainage techniques

Stockholm

Burr hole surgery with active subgaleal drainage

Procedure: Burr hole surgery with various drainage techniques

Interventions

Burr hole surgery with various drainage techniquesPROCEDURE

Surgical technique 1. Continuous irrigation and drainage 2. Passive subdural drain 3. Active subgaleal drain

StockholmTromsøTrondheim

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients have been selected to the given therapy solely on the basis of geography. All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at St.Olav University Hospital and UNN, and primary CSDH from 2006 through 2010 at Karolinska University Hospital (not 2005 due to practical reasons since major changes occurred in electronic surgery protocols 2005).

You may qualify if:

  • All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at St.Olav University Hospital
  • All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at University Hospital North Norway
  • All patients treated with evacuation of primary CSDH from 2006 through 2010 at Karolinska University Hospital (not 2005 due to practical reasons since major changes occurred in electronic surgery protocols 2005).

You may not qualify if:

  • Chronic subdural hematoma in arachnoid cyst(s)
  • Previous CSDH surgery
  • External hydrocephalus (hydrocephalus with cerebrospinal fluid (CSF) in the subdural space rather than in the ventricles)
  • CSDH due to previous intracranial surgery (within 6 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital of North Norway

Tromsø, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (1)

  • Sjavik K, Bartek J, Sagberg LM, Henriksen ML, Gulati S, Stahl FL, Kristiansson H, Solheim O, Forander P, Jakola AS. Assessment of drainage techniques for evacuation of chronic subdural hematoma: a consecutive population-based comparative cohort study. J Neurosurg. 2017 Jun 23;133(4):1113-1119. doi: 10.3171/2016.12.JNS161713.

    PMID: 28644099RESULT

MeSH Terms

Conditions

Hematoma, Subdural, ChronicPostoperative Complications

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lars Jacob Stovner, MD PhD

    St. Olavs Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2013

First Posted

August 29, 2013

Study Start

June 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

NO(2)SE(1)