Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH)

• Status: Unknown status
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Ford Health System
• Treatments: Clevidipine

Criteria

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