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NCT Number: NCT07421453

Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Siebe Orolé, Medical degree

CONTACT

[email protected]

+32 16 34 42 90

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recurrence rate

    Time frame: 6 months after surgery

    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.

Secondary outcomes

  1. Length-of-stay

    Time frame: Up to 6 months after surgery

  2. Complication incidence

    Time frame: 30 days after surgery

    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.

  3. Mortality

    Time frame: 30 days after surgery

    30-day mortality

  4. 5-level EQ-5D (EQ-5D-5L)

    Time frame: 6 months after surgery

    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.

  5. modified Rankin Scale (mRS)

    Time frame: 6 months after surgery

    Scale measuring degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms at all) to 5 (dead).

Study contacts

Contact information is provided by the study sponsor or research team.

Siebe Orolé, Medical degree

CONTACT

[email protected]

+32 16 34 42 90

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Enhanced Recovery Pathway for Chronic Subdural Hematoma

Acronym: ERP-cSDH

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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