[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555322":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":38,"centralContacts":33,"locations":47,"responsibleParty":69,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":33,"enrollmentInfo":85,"targetDuration":33,"studyType":88,"phases":89,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":50,"whyStopped":33,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"The Cooper Health System","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1 Unilateral cSDH\u002F 2mg\u002Fkg Arm","EXPERIMENTAL","During phase 1, single 2mg\u002Fkg dose of bevacizumab to treat unilateral cSDH",[13],"Drug: Bevacizumab 2 mg\u002Fkg",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1 Bilateral cSDH\u002F 4mg\u002Fkg Arm","During phase 1, two 2mg\u002Fkg doses (cumulatively 4mg\u002Fkg) of bevacizumab to treat bilateral cSDH",[18],"Drug: Bevacizumab 4 mg\u002Fkg",{"label":20,"type":10,"description":21,"interventionNames":22},"Phase 2 Unilateral cSDH\u002F 2mg\u002Fkg Arm","During phase 2, single 2mg\u002Fkg dose of bevacizumab to treat unilateral cSDH",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Phase 2 Bilateral cSDH\u002F 4mg\u002Fkg Arm","During phase 2, two 2mg\u002Fkg doses (cumulatively 4mg\u002Fkg) of bevacizumab to treat bilateral cSDH",[18],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Bevacizumab 2 mg\u002Fkg","Single 2mg\u002Fkg dose of bevacizumab to treat unilateral cSDH",[9,20],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Bevacizumab 4 mg\u002Fkg","Two 2mg\u002Fkg doses (cumulatively 4mg\u002Fkg) of bevacizumab to treat bilateral cSDH",[15,24],[39,42,45],{"name":40,"affiliation":5,"role":41},"Jane Khalife, MD","PRINCIPAL_INVESTIGATOR",{"name":43,"affiliation":5,"role":44},"Ajith J Thomas, MD","STUDY_CHAIR",{"name":46,"affiliation":5,"role":44},"Manisha Koneru, MD",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Cooper University Health Care","RECRUITING","Camden","New Jersey","08103","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-75.11962,39.92595,{"lat":60,"lon":59},[63,68],{"name":64,"role":65,"phone":66,"phoneExt":33,"email":67},"Cooper Neurological Institute","CONTACT","855-306-3876","cniresearch@cooperhealth.edu",{"name":40,"role":41,"phone":33,"phoneExt":33,"email":33},{"type":41,"investigatorFullName":40,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Assistant Professor of Neurology",[72],{"name":73,"class":74},"Society of Vascular and Interventional Neurology","UNKNOWN","100555322","phase-1-chronic-subdural-hematoma-treatment-with-intra-arterial-bevacizumab-injection-100555322",false,"NCT06510582","Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection","Chronic Subdural Hematoma Treatment With Avastin® (Bevacizumab) Intra-Arterial Injection: A Non-Randomized, Open-Label Phase 1\u002F2 Clinical Trial","CHAI","Inclusion Criteria:\n\n* Adult patients (≥18 years)\n* Radiographic evidence of chronic subdural hematoma, including\n\n  1. Persistence of subdural blood more than 10 days after index traumatic injury or event\n  2. Presence of mixed density blood\n  3. Presence of subdural membranes\n* Can obtain informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study.\n* Patients with concomitant intracranial pathology other than subdural hematoma (e.g., intracranial malignancy).\n* Patients with known hypersensitivity to bevacizumab.\n* Patients with radiographic evidence of mass effect.\n* Patients have focal neurological deficits attributed to subdural hematoma.\n* Patient had craniotomy or burr hole operative procedures performed in preceding two weeks prior to onset of subdural hematoma.\n* Secondary causes apart from trauma for the chronic subdural hematoma, such as underlying vascular abnormality or tumor.\n* Emergent surgical evacuation is required for the patient.\n* Non-convexity chronic subdural hematoma, as the middle meningeal artery will not supply this area.\n* Coagulation abnormalities, including platelet count \\\u003C100,000 and\u002For international normalized ratio of \\\u003C1.5 despite attempts for correction.\n* Patients with known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids.\n* Patient has known active systemic infection or sepsis.\n* Patient has contradiction to anesthetic agents used for conscious sedation\u002Fmonitored anesthesia care (MAC).\n* Patient has life expectancy of less than six months due to comorbid terminal conditions.\n* Patient has a premorbid modified Rankin score (mRS) of 5 or greater.\n* Concurrent participation in another research protocol for investigation of an experimental therapy.","ALL","18 Years",{"count":86,"type":87},140,"ESTIMATED","INTERVENTIONAL",[90,91],"PHASE1","PHASE2","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).\n\nThe main questions it aims to answer are:\n\n* Is bevacizumab infusion safe in cSDH patients?\n* Is bevacizumab infusion effective in treating cSDH?",[94],"Chronic Subdural Hematoma",[96,97,98,99,100],"Chronic subdural hematoma","Chronic intracranial subdural hematoma","Vascular endothelial growth factor","Bevacizumab","Middle meningeal artery embolization","2025-06-25",{"date":103,"type":104},"2025-07-01","ACTUAL",{"date":106,"type":104},"2024-06-17",{"date":108,"type":87},"2028-06",{"name":5,"class":6},1]