- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06510582
Traitement de l'hématome sous-dural chronique par injection intra-artérielle de bevacizumab (CHAI)
Traitement de l'hématome sous-dural chronique avec injection intra-artérielle d'Avastin® (Bevacizumab) : un essai clinique de phase 1/2 ouvert et non randomisé
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:
- Is bevacizumab infusion safe in cSDH patients?
- Is bevacizumab infusion effective in treating cSDH?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This protocol was originally proposed as a phase I/II trial. Phase 1 was completed; planned phase 2 was discontinued prior to initiation.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
New Jersey
-
Camden, New Jersey, États-Unis, 08103
- Cooper University Health Care
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
-
Adult patients (≥18 years)
-
Radiographic evidence of chronic subdural hematoma, including
- Persistence of subdural blood more than 10 days after index traumatic injury or event
- Presence of mixed density blood
- Presence of subdural membranes
-
Can obtain informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
Exclusion Criteria:
- Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study.
- Patients with concomitant intracranial pathology other than subdural hematoma (e.g., intracranial malignancy).
- Patients with known hypersensitivity to bevacizumab.
- Patients with radiographic evidence of mass effect.
- Patients have focal neurological deficits attributed to subdural hematoma.
- Patient had craniotomy or burr hole operative procedures performed in preceding two weeks prior to onset of subdural hematoma.
- Secondary causes apart from trauma for the chronic subdural hematoma, such as underlying vascular abnormality or tumor.
- Emergent surgical evacuation is required for the patient.
- Non-convexity chronic subdural hematoma, as the middle meningeal artery will not supply this area.
- Coagulation abnormalities, including platelet count <100,000 and/or international normalized ratio of <1.5 despite attempts for correction.
- Patients with known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids.
- Patient has known active systemic infection or sepsis.
- Patient has contradiction to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC).
- Patient has life expectancy of less than six months due to comorbid terminal conditions.
- Patient has a premorbid modified Rankin score (mRS) of 5 or greater.
- Concurrent participation in another research protocol for investigation of an experimental therapy.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Phase 1 Unilateral cSDH/ 2mg/kg Arm
During phase 1, single 2mg/kg dose of bevacizumab to treat unilateral cSDH |
Single 2mg/kg dose of bevacizumab to treat unilateral cSDH |
|
Expérimental: Phase 1 Bilateral cSDH/ 4mg/kg Arm
During phase 1, two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH |
Two 2mg/kg doses (cumulatively 4mg/kg) of bevacizumab to treat bilateral cSDH |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants with Serious Adverse Events
Délai: Up to 3 months after study treatment
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of Hematoma Recurrence
Délai: 3 months after study treatment and 6 months after study treatment
|
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
Délai: 3 months after study treatment and 6 months after study treatment
|
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
Délai: 3 months after study treatment and 6 months after study treatment
|
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
Délai: 3 months after study treatment and 6 months after study treatment
|
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
Délai: 3 months after study treatment and 6 months after study treatment
|
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
Délai: 3 months after study treatment and 6 months after study treatment
|
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
Délai: 3 months after study treatment and 6 months after study treatment
|
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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants with Anatomical Variants
Délai: During the treatment procedure
|
Middle meningeal arteries with dangerous anastomoses observed on imaging |
During the treatment procedure
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Manisha Koneru, MD, The Cooper Health System
- Chercheur principal: Jane Khalife, MD, The Cooper Health System
- Chaise d'étude: Ajith J Thomas, MD, The Cooper Health System
Publications et liens utiles
Publications générales
- Khalife J, Koneru M, Thomas AJ. Inflammation as a Key Driver for Chronic Subdural Hematomas. Stroke. 2026 Jul;57(7):1908-1919. doi: 10.1161/STROKEAHA.126.055340. Epub 2026 May 27.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies vasculaires
- Maladies cardiovasculaires
- Blessures et Blessures
- Processus pathologiques
- Maladie chronique
- Attributs de la maladie
- Hémorragie
- Traumatisme crânio-cérébral
- Traumatisme, système nerveux
- Hémorragies intracrâniennes
- Hémorragie intracrânienne, traumatique
- Conditions pathologiques, signes et symptômes
- Hématome sous-dural
- Hématome
- Hématome, sous-dural, chronique
- Acides aminés, peptides et protéines
- Protéines
- Anticorps, monoclonal, humanisé
- Anticorps, monoclonal
- Anticorps
- Immunoglobulines
- Immunoprotéines
- Protéines sanguines
- Globulines sériques
- Globulines
- Bévacizumab
Autres numéros d'identification d'étude
- 23-154
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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