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

Enhanced Recovery Pathway for Chronic Subdural Hematoma

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematoma; Chronic Subdural Hematomas

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Siebe Orolé, Medical degree; Phone Number: +32 16 34 42 90; Email: neurochirurgie@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospitals Leuven
    • Contact: Siebe Orolé, Medical degree; Phone Number: +32 16 34 42 90; Email: neurochirurgie@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ERP-cohort; Cohort of patients treated after ERP-implementation, prospective data collection
Pre-ERP-cohort; Patients treated before ERP-implementation, retrospective identified

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length-of-stay		Up to 6 months after surgery
Complication incidence	Complications will be classified as medical complications (any nonsurgical complication occurring during the hospital stay after the surgery) and surgical complications. Medical complications are considered minor if complete recovery is to be expected (eg, electrolyte disturbances or urinary tract infection) and major in case of potential serious consequences and partial or no recovery (eg, stroke, severe pneumonia, or pulmonary embolism). Surgical complications are defined as every complication directly related to the surgery. Epileptic seizures in the postoperative period will be considered separately.	30 days after surgery
Mortality	30-day mortality	30 days after surgery
5-level EQ-5D (EQ-5D-5L)	The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive systems score ranges from 5 to 25, with a higher score meaning worse health. De EQ VAS is scored from 0 to 100, with a higher score meaning better self-rated health.	6 months after surgery
modified Rankin Scale (mRS)	Scale measuring degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms at all) to 5 (dead).	6 months after surgery

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Thomas Decramer, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: September 1, 2025
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Chronic subdural hematoma; Burr-hole drainage; Enhanced recovery protocol
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Pathological Conditions, Signs and Symptoms; Hematoma, Subdural; Hematoma; Hematoma, Subdural, Chronic
• Other Study ID Numbers: S68819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No