Irrigation of Chronic Subdural Hematomas - is More Better?

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

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.

Study Overview

• Status: Completed
• Conditions: Hematoma, Subdural, Chronic
• Intervention / Treatment: Procedure: Burr hole surgery with various drainage techniques

• Study Type: Observational
• Enrollment (Actual): 1258

Contacts and Locations

Study Locations

• Norway
  • Tromsø, Norway
    • University Hospital of North Norway
  • Trondheim, Norway
    • St Olavs Hospital
• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trondheim; Burr hole surgery with passive subdural drainage	Procedure: Burr hole surgery with various drainage techniques; Surgical technique; Continuous irrigation and drainage; Passive subdural drain; Active subgaleal drain
Tromsø; Burr hole surgery with continuous irrigation	Procedure: Burr hole surgery with various drainage techniques; Surgical technique; Continuous irrigation and drainage; Passive subdural drain; Active subgaleal drain
Stockholm; Burr hole surgery with active subgaleal drainage	Procedure: Burr hole surgery with various drainage techniques; Surgical technique; Continuous irrigation and drainage; Passive subdural drain; Active subgaleal drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reoperations	Number of reoperations (X/N, %) between centers	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
continuous irrigation versus other drainage	Number of reoperations with use of continuous irrigation (UNN) versus other drainage (St.Olav, Karolinska)	1 year
perioperative death		30 days
survival	Minimum 3 years follow up. Report 1 year mortality and use of Kaplan Meier curves (log rank test)	3 years
surgical complications	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	30 days

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Karolinska Institutet; University Hospital of North Norway; Norwegian University of Science and Technology
• Investigators: Study Chair: Lars Jacob Stovner, MD PhD, St. Olavs Hospital

Publications and helpful links

General Publications

• Sjavik K, Bartek J Jr, 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 23:1-7. doi: 10.3171/2016.12.JNS161713. Online ahead of print.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 22, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 24, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: surgery; mortality; drainage; postoperative complications; trephining; therapeutic irrigation; subdural space
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: 2011/2050