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Irrigation of Chronic Subdural Hematomas - is More Better?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01930617
First Posted: August 29, 2013
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Norwegian University of Science and Technology
University Hospital of North Norway
Karolinska Institutet
Information provided by (Responsible Party):
St. Olavs Hospital
  Purpose

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.


Condition Intervention
Hematoma, Subdural, Chronic Procedure: Burr hole surgery with various drainage techniques

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Irrigation of Chronic Subdural Hematomas - is More Better? A Population Based Study Between Different Treatment Policies

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • reoperations [ Time Frame: 1 year ]
    Number of reoperations (X/N, %) between centers


Secondary Outcome Measures:
  • continuous irrigation versus other drainage [ Time Frame: 1 year ]
    Number of reoperations with use of continuous irrigation (UNN) versus other drainage (St.Olav, Karolinska)

  • perioperative death [ Time Frame: 30 days ]
  • survival [ Time Frame: 3 years ]
    Minimum 3 years follow up. Report 1 year mortality and use of Kaplan Meier curves (log rank test)

  • surgical complications [ Time Frame: 30 days ]
    As defined by the Ibanez classification where it is the treatment given for a complication that gives the score. Medical and surgical complication is both mentioned and reported seperately


Enrollment: 1258
Study Start Date: June 2014
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Trondheim
Burr hole surgery with passive subdural drainage
Procedure: Burr hole surgery with various drainage techniques

Surgical technique

  1. Continuous irrigation and drainage
  2. Passive subdural drain
  3. Active subgaleal drain
Tromsø
Burr hole surgery with continuous irrigation
Procedure: Burr hole surgery with various drainage techniques

Surgical technique

  1. Continuous irrigation and drainage
  2. Passive subdural drain
  3. Active subgaleal drain
Stockholm
Burr hole surgery with active subgaleal drainage
Procedure: Burr hole surgery with various drainage techniques

Surgical technique

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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).
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930617


Locations
Norway
University Hospital of North Norway
Tromsø, Norway
St Olavs Hospital
Trondheim, Norway
Sweden
Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
University Hospital of North Norway
Karolinska Institutet
Investigators
Study Chair: Lars Jacob Stovner, MD PhD St. Olavs Hospital
  More Information

Publications:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01930617     History of Changes
Other Study ID Numbers: 2011/2050
First Submitted: August 22, 2013
First Posted: August 29, 2013
Last Update Posted: June 27, 2017
Last Verified: June 2017

Keywords provided by St. Olavs Hospital:
surgery
trephining
drainage
therapeutic irrigation
subdural space
postoperative complications
mortality

Additional relevant MeSH terms:
Hematoma
Hematoma, Subdural
Hematoma, Subdural, Chronic
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries