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| Name | Class |
|---|---|
| Society of Vascular and Interventional Neurology | UNKNOWN |
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The goal of this clinical trial is to test whether infusing bevacizumab into the middle meningeal arteries can be used to treat chronic subdural hematomas (cSDH).
The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Unilateral cSDH/ 2mg/kg Arm | Experimental | During phase 1, single 2mg/kg dose of bevacizumab to treat unilateral cSDH |
|
| Phase 1 Bilateral cSDH/ 4mg/kg Arm | Experimental | During phase 1, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH |
|
| Phase 2 Unilateral cSDH/ 2mg/kg Arm | Experimental | During phase 2, single 2mg/kg dose of bevacizumab to treat unilateral cSDH |
|
| Phase 2 Bilateral cSDH/ 4mg/kg Arm | Experimental | During phase 2, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab 2 mg/kg | Drug | Single 2mg/kg dose of bevacizumab to treat unilateral cSDH |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Serious Adverse Events | Reported serious adverse events classified using MedDRA and CTCAE, in addition to treatment-related events and all other adverse events | Up to 3 months after study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Hematoma Recurrence | Rate of hematoma recurrence or progression requiring intervention and/or readmission | 3 months after study treatment and 6 months after study treatment |
| Rate of Complete Hematoma Resolution |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Anatomical Variants | Middle meningeal arteries with dangerous anastomoses observed on imaging | During the treatment procedure |
Inclusion Criteria:
Adult patients (≥18 years)
Radiographic evidence of chronic subdural hematoma, including
Can obtain informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Khalife, MD | The Cooper Health System | Principal Investigator |
| Ajith J Thomas, MD | The Cooper Health System | Study Chair |
| Manisha Koneru, MD | The Cooper Health System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Health Care | Recruiting | Camden | New Jersey | 08103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41583665 | Background | Khalife J, Tonetti DA, Shaikh H, Jovin T, Patel P, Thomas A. Intraarterial Bevacizumab Administration Through the Middle Meningeal Artery for Chronic Subdural Hematoma. Stroke Vasc Interv Neurol. 2023 Feb 25;3(4):e000722. doi: 10.1161/SVIN.122.000722. eCollection 2023 Jul. | |
| 41586284 | Background | Khalife J, Koneru M, Tonetti DA, Shaikh HA, Jovin TG, Patel PD, Thomas AJ. Intra-arterial Selective Bevacizumab Administration in the Middle Meningeal Artery for Chronic Subdural Hematoma: An Early Experience in 12 Hemispheres. Stroke Vasc Interv Neurol. 2024 Jul 22;4(5):e001409. doi: 10.1161/SVIN.124.001409. eCollection 2024 Sep. |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab 4 mg/kg | Drug | Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH |
|
Rate of complete hematoma resolution compared to baseline on imaging
| 3 months after study treatment and 6 months after study treatment |
| Rate of Partial Hematoma Resolution | Rate of at least 50% or greater reduction in hematoma size from baseline on imaging | 3 months after study treatment and 6 months after study treatment |
| Change in Hematoma Size | Change in hematoma size measured in millimeters on imaging | 3 months after study treatment and 6 months after study treatment |
| Change in Clinical Neurological Symptom Scale Scores: NIHSS | Change in National Institutes of Health Stroke Scale (NIHSS) scores, scores range from 0 to 42, with higher scores indicating more severe neurological deficit | 3 months after study treatment and 6 months after study treatment |
| Change in Clinical Neurological Symptom Scale Scores: GCS | Change in Glasgow Coma Scale (GCS) scores, ranging from 3 to 15 with lower score indicating more impaired consciousness | 3 months after study treatment and 6 months after study treatment |
| Change in Clinical Neurological Symptom Scale Scores: mRS | Change in modified Rankin Scale (mRS) scores, ranges from 0-6 with higher score indicating worse functional outcome | 3 months after study treatment and 6 months after study treatment |
| 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |