Irrigation of Chronic Subdural Hematomas - is More Better?

Hematoma, Subdural, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930617
• Other study ID #: 2011/2050
• Status: Completed
• Phase: N/A
• First received: August 22, 2013
• Last updated: June 24, 2017
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1258
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• Burr hole surgery with various drainage techniques
Surgical technique Continuous irrigation and drainage Passive subdural drain Active subgaleal drain

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø
Norway	St Olavs Hospital	Trondheim
Sweden	Karolinska University Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
St. Olavs Hospital	Karolinska Institutet, Norwegian University of Science and Technology, University Hospital of North Norway

Countries where clinical trial is conducted

Norway,  Sweden, 

References & Publications (1)

Sjåvik K, Bartek J Jr, Sagberg LM, Henriksen ML, Gulati S, Ståhl FL, Kristiansson H, Solheim O, Förander P, Jakola AS. Assessment of drainage techniques for evacuation of chronic subdural hematoma: a consecutive population-based comparative cohort study. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reoperations	Number of reoperations (X/N, %) between centers	1 year
Secondary	continuous irrigation versus other drainage	Number of reoperations with use of continuous irrigation (UNN) versus other drainage (St.Olav, Karolinska)	1 year
Secondary	perioperative death		30 days
Secondary	survival	Minimum 3 years follow up. Report 1 year mortality and use of Kaplan Meier curves (log rank test)	3 years
Secondary	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