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Irrigation of Chronic Subdural Hematomas - is More Better?

NCT01930617 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1258

Last updated 2017-06-27

No results posted yet for this study

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.

Conditions

  • Hematoma, Subdural, Chronic

Interventions

PROCEDURE

Burr hole surgery with various drainage techniques

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

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Lars Jacob Stovner, MD PhD · St. Olavs Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Norway
  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01930617 on ClinicalTrials.gov