Clevidipine for Vasospasm After Subarachnoid Hemorrhage

HFHS-CLEVIDIPINE-PV

Vasospasm occurs frequently after aneurysmal subarachnoid hemorrhage and can lead to strokes. The investigators will investigate if infusion of a novel drug, clevidipine, will decrease vasospasm during the infusion and post infusion period using transcranial doppler monitoring of patients with subarachnoid hemorrhage and moderate severity vasospasm

2014-03-01

2018-03-01

2018-09-01

Withdrawn

Early phase I

Inclusion Criteria: * Age 18-80 years * Diagnosis of SAH (as diagnosed per history, neuroimaging or lumbar puncture) * Presence of a secured aneurysm via clipping or coiling * Hunt and Hess grade \< 5 (non-sedated or paralyzed patients) * Glasgow Coma scale \> 4 (non-sedated or paralyzed patients) * MAP goal set by the treating physicians * Temporal insonation window presence on TCD * Moderate supratentorial vasospasm as per daily TCD (CBFV between 130-180 cm/sec or Lindergaard index 3-5 for the Middle Cerebral artery or Internal Cerebral artery or Anterior Cerebral artery) Exclusion Criteria: * Very young or very old patients (\<18 or \>80 years old) * Traumatic SAH (no aneurysm identified after initial work-up) or Perimesencephalic SAH is also excluded * Hunt and Hess grade 5 (deeply comatose or brain dead patients) * Glasgow Coma scale 3 or 4 (brain dead or deeply comatose patients) * Patients with mild or severe supratentorial vasospasm (CBFV \< 120 cm/sec or Lindergaard index \< 3 or \> 200 cm/sec or Lindergaard index \> 6, respectively, for the Middle Cerebral artery or Internal Cerebral artery or Anterior Cerebral artery) * Patients with vasospasm only in the posterior circulation (CBFV \> 80 cm/sec for Vertebral or Basilar artery) * Patients with severe tachycardia (heart rate \> 110) * Patients with preexisting left bundle branch block or permanent ventricular pacemaker * Patients with known allergy to dihydropyridines including clevidipine or allergic to soybeans, soy products, eggs, or egg products * Patients with defective lipid metabolism such as pathologic hyperlipemia or lipoid nephrosis * Patients with acute pancreatitis, if it is accompanied by hyperlipidemia * Patients with severe aortic stenosis * Pregnant patients

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-02-01