Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH)

NCT02011321 | Withdrawn Phase 2

• 1 other identifier: HFHS-CLEVIDIPINE-PV
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Subarachnoid Hemorrhage; Cerebral Aneurysm; Vasospasm, Intracranial

Keywords

subarachnoid hemorrhage; aneurysm; vasospasm; clevidipine; transcranial dopplers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Safety and Tolerability: Intracranial pressure (ICP) change during infusion compared to pre-infusion

  ICP will be measured at the end of pre-infusion period and at the end of the infusion period

• Safety and tolerability: pressor requirement to counteract a 10% or more drop of mean arterial pressure (MAP) during the infusion period

  MAP measurements every minute during the pre-infusion and infusion period

Study Arms (1)

clevidipine

EXPERIMENTAL

Four-hour infusion of low-dose intravenous clevidipine in patients with moderate vasospasm after aneurysmal subarachnoid hemorrhage

Drug: clevidipine

Interventions

clevidipine DRUG

clevidipine infusion x4 hours

Also known as: Cleviprex

clevidipine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

• 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.

  PMID: 24007334 BACKGROUND

• 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.

  PMID: 22251017 BACKGROUND

Related Links

• Clevidipine information

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Intracranial Aneurysm; Vasospasm, Intracranial; Aneurysm

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases

Study Officials

• Panayiots Varelas, MD, PhD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

• Tamer Abdelhak, MD

  Henry Ford Health System

  STUDY DIRECTOR

• Mohammed Rehman, DO

  Henry Ford Health System

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head Neurosciences Critical Care

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 13, 2013
• Study Start: March 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (1)