Subarachnoid Hemorrhage Clinical Trial
— CLEVASOfficial title:
Clevidipine for Vasospasm After Subarachnoid Hemorrhage
Verified date | January 2023 |
Source | Henry Ford Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford hospital | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System |
United States,
Espina IM, Varon J. Clevidipine : a state-of-the-art antihypertensive drug under the scope. Expert Opin Pharmacother. 2012 Feb;13(3):387-93. doi: 10.1517/14656566.2012.651126. Epub 2012 Jan 18. — View Citation
Varelas PN, Abdelhak T, Corry JJ, James E, Rehman MF, Schultz L, Mays-Wilson K, Mitsias P. Clevidipine for acute hypertension in patients with subarachnoid hemorrhage: a pilot study. Int J Neurosci. 2014 Mar;124(3):192-8. doi: 10.3109/00207454.2013.836703. Epub 2013 Sep 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy: Change of cerebral blood flow velocities during infusion of clevidipine compared to baseline pre-infusion by >10% at 15 min after start of infusion and/or at 1, 2,3 and 4 hours (during the infusion). | Efficacy: We will compare pre-infusion, infusion and post-infusion CBFVs measured by TCD as a surrogate of vasospasm. We will assess the percentage of measurements meeting the primary outcome of 10% change of cerebral blood flow velocities during the infusion period compared to pre-infusion | 15 min after start of infusion and at 1, 2,3 and 4 hours (during the infusion). | |
Secondary | Safety and Tolerability: Intracranial pressure (ICP) change during infusion compared to pre-infusion | The mean difference between pre-infusion and end-of-infusion ICP will be calculated. Any change > 10 mm Hg (elevation or decrease) will be reported as a safety issue | ICP will be measured at the end of pre-infusion period and at the end of the infusion period | |
Secondary | Safety and tolerability: pressor requirement to counteract a 10% or more drop of mean arterial pressure (MAP) during the infusion period | Safety & Tolerability: if during infusion the Mean arterial pressure drops > 10% compared to pre-infusion (mean MAP measurements during this period), a pressor (neosynephrine) drip will be initiated to counteract this effect systemically and bring the MAP at the mean pre-infusion level. The percentage of participants who will need this rescue treatment will be reported | MAP measurements every minute during the pre-infusion and infusion period |
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