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Completed

NCT Number: NCT01930617

Irrigation of Chronic Subdural Hematomas - is More Better?

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.

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Key information

Conditions

Hematoma, Subdural, Chronic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Craniocerebral Trauma Disease Attributes Hematoma Hematoma, Subdural Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of North Norway, Tromsø, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Burr hole surgery with various drainage techniques

Procedure

Surgical technique

  • Continuous irrigation and drainage
  • Passive subdural drain
  • Active subgaleal drain

Primary outcomes

  1. reoperations

    Time frame: 1 year

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

Secondary outcomes

  1. continuous irrigation versus other drainage

    Time frame: 1 year

    Number of reoperations with use of continuous irrigation (UNN) versus other drainage (St.Olav, Karolinska)

  2. perioperative death

    Time frame: 30 days

  3. survival

    Time frame: 3 years

    Minimum 3 years follow up. Report 1 year mortality and use of Kaplan Meier curves (log rank test)

  4. 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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Karolinska Institutet
  • Norwegian University of Science and Technology
  • University Hospital of North Norway

Registry information

Official study title

Irrigation of Chronic Subdural Hematomas - is More Better? A Population Based Study Between Different Treatment Policies

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 29, 2013
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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