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

NCT07421453 | Recruiting DMC

• 1 other identifier: S68819
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Subdural Hematoma; Chronic Subdural Hematomas

Keywords

Chronic subdural hematoma; Burr-hole drainage; Enhanced recovery protocol

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

  Recurrence is defined as persistent deficits, clinical deterioration or radiographic hematoma enlargement requiring ipsilateral re-intervention (surgical or by means of middle meningeal artery embolization), assessed until 6 months after index surgery.

  6 months after surgery

Secondary Outcomes (5)

• Length-of-stay

  Up to 6 months after surgery

• Complication incidence

  30 days after surgery

• Mortality

  30 days after surgery

• 5-level EQ-5D (EQ-5D-5L)

  6 months after surgery

• modified Rankin Scale (mRS)

  6 months after surgery

Study Arms (2)

ERP-cohort

Cohort of patients treated after ERP-implementation, prospective data collection

Pre-ERP-cohort

Patients treated before ERP-implementation, retrospective identified

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients of 18 years or older with a chronic subdural hematoma for which burr-hole drainage is scheduled.

You may qualify if:

• Age 18 years or older
• Existence of a chronic subdural hematoma requiring burr-hole drainage
• Written informed consent to participate in the study must be obtained from the subject. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject. When the patient is considered capable to consent but physically unable to sign an informed consent form and a representative is not available an impartial witness can attend the informed consent process.

You may not qualify if:

• Existence of an important underlying cerebral lesion (e.g. a vascular lesion, tumor)
• History of treatment (surgical or by middle meningeal artery embolization) of a same sided cSDH

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (2)

• Link TW, Rapoport BI, Paine SM, Kamel H, Knopman J. Middle meningeal artery embolization for chronic subdural hematoma: Endovascular technique and radiographic findings. Interv Neuroradiol. 2018 Aug;24(4):455-462. doi: 10.1177/1591019918769336. Epub 2018 May 2.

  PMID: 29720020 BACKGROUND

• Feghali J, Yang W, Huang J. Updates in Chronic Subdural Hematoma: Epidemiology, Etiology, Pathogenesis, Treatment, and Outcome. World Neurosurg. 2020 Sep;141:339-345. doi: 10.1016/j.wneu.2020.06.140. Epub 2020 Jun 25.

  PMID: 32593768 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Decramer, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siebe Orolé, Medical degree

CONTACT

+32 16 34 42 90; neurochirurgie@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgical trainee

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: February 19, 2026
• Study Start: December 23, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

BE (1)