Actively Recruiting

Age: 18Years +
All Genders
NCT07421453

Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-02-19

150

Participants Needed

1

Research Sites

188 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A chronic subdural hematoma (cSDH) is a type of intracranial hematoma that primarily affects older adults. The rising incidence of this condition, coupled with the high healthcare burden of this disease, calls for an update of the medical care program. We introduced an enhanced recovery protocol (ERP) at our center for patients undergoing surgical treatment (by means of burr-hole drainage) for a cSDH. Our ERP includes guidelines for treatment decisions (surgery or middle meningeal artery embolization), modifications in surgical techniques, and standardized postoperative management strategies. This study prospectively analyses the safety and efficacy of this enhanced recovery protocol for patients undergoing burr hole drainage of a chronic subdural hematoma. Safety and efficacy outcomes will be compared with outcomes of a historical patient cohort. Safety of the protocol will be measured in terms of recurrence rate (6-month follow-up, primary outcome), complication incidence, and 30-day mortality. Efficacy of the enhanced recovery protocol will be represented by the length-of-stay.

CONDITIONS

Official Title

Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Presence of a chronic subdural hematoma needing burr-hole drainage
  • Provided written informed consent or consent obtained from a legally acceptable representative if the patient cannot consent themselves
  • If unable to sign consent and no representative available, an impartial witness can attend the consent process
Not Eligible

You will not qualify if you...

  • Presence of significant underlying brain lesions such as vascular lesions or tumors
  • Previous treatment of the same sided chronic subdural hematoma by surgery or middle meningeal artery embolization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospitals Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

S

Siebe Orolé, Medical degree

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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