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Irrigation of Chronic Subdural Hematomas - is More Better?

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by St. Olavs Hospital
Sponsor:
Collaborators:
Norwegian University of Science and Technology
University Hospital of North Norway
Karolinska Institutet
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01930617
First received: August 22, 2013
Last updated: June 7, 2014
Last verified: November 2013
  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 ] [ Designated as safety issue: No ]
    Number of reoperations (X/N, %) between centers


Secondary Outcome Measures:
  • continuous irrigation versus other drainage [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of reoperations with use of continuous irrigation (UNN) versus other drainage (St.Olav, Karolinska)

  • perioperative death [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Minimum 3 years follow up. Report 1 year mortality and use of Kaplan Meier curves (log rank test)

  • surgical complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 950
Study Start Date: June 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930617

Contacts
Contact: Asgeir S Jakola, MD PhD 0047 72575567 asgeir.s.jakola@ntnu.no
Contact: Ole Solheim, MD PhD ole.solheim@ntnu.no

Locations
Norway
University Hospital of North Norway Recruiting
Tromsø, Norway
Contact: Kristin Sjåvik, MD       Kristin.Sjavik@unn.no   
Contact: Marte Lødemel Henriksen, MD         
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Ole Solheim, MD PhD       ole.solheim@ntnu.no   
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Jiri Bartek jr, MD       jiri.bartek@karolinska.se   
Contact: Petter Forander, MD PhD       petter.forander@karolinska.se   
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
University Hospital of North Norway
Karolinska Institutet
Investigators
Study Chair: Asgeir S Jakola, MD PhD St. Olavs Hospital
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01930617     History of Changes
Other Study ID Numbers: 2011/2050
Study First Received: August 22, 2013
Last Updated: June 7, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Craniocerebral Trauma
Hemorrhage
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014