Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERP-cohort | Cohort of patients treated after ERP-implementation, prospective data collection | ||
| Pre-ERP-cohort | Patients treated before ERP-implementation, retrospective identified |
Not provided
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients of 18 years or older with a chronic subdural hematoma for which burr-hole drainage is scheduled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siebe Orolé, Medical degree | Contact | +32 16 34 42 90 | neurochirurgie@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Decramer, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Recruiting | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29720020 | Background | 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. | |
| 32593768 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2024 | Sep 1, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |