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Trial record 51 of 195 for:    Hemorrhage AND SAH

Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH) (CLEVAS)

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ClinicalTrials.gov Identifier: NCT02011321
Recruitment Status : Unknown
Verified December 2013 by Panayiotis Varelas, Henry Ford Health System.
Recruitment status was:  Not yet recruiting
First Posted : December 13, 2013
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
Panayiotis Varelas, Henry Ford Health System

Tracking Information
First Submitted Date  ICMJE December 2, 2013
First Posted Date  ICMJE December 13, 2013
Last Update Posted Date December 13, 2013
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
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). [ Time Frame: 15 min after start of infusion and 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
  • Safety and Tolerability: Intracranial pressure (ICP) change during infusion compared to pre-infusion [ Time Frame: ICP will be measured at the end of pre-infusion period and at the end of the infusion period ]
    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
  • Safety and tolerability: pressor requirement to counteract a 10% or more drop of mean arterial pressure (MAP) during the infusion period [ Time Frame: MAP measurements every minute during the pre-infusion and 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH)
Official Title  ICMJE Clevidipine for Vasospasm After Subarachnoid Hemorrhage
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
Detailed Description

Cerebral vasospasm after aneurysmal subarachnoid hemorrhage (SAH) is a major cause of morbidity and mortality days after securing the aneurysm due to development of cerebral ischemia and strokes. Vasospasm is detected by measuring the blood flow velocities in the cerebral circulation via daily Transcranial Dopplers (TCD). There is no effective treatment except for a per os calcium channel blocker (nimodipine) and for keeping the patient hypertensive and with euvolemia or hypervolemia. A recently proposed option is to dilate the cerebral vessels by infusing continuously another vasodilatory calcium channel blocker, nicardipine, and supporting the systemic blood pressure (BP) with vasopressors which do not constrict the cerebral vasculature at the same time. Nicardipine has also been used extensively intra-arterially as a bolus or infusion to dilate the vasospastic cerebral vessels as a rescue therapy for severe vasospasm.

Clevidipine is a novel, short-acting calcium channel blocker, which in a small series of patients with SAH at Henry Ford Hospital, was able to control the elevated BP very efficiently and within a narrow window, without adverse events. It has never been used before for ameliorating vasospasm, but theoretically offers advantages compared to nicardipine due to its shorter half-life and easier titratability. Except for use of clevidipine for BP control in the investigators previous study, there are no data on clevidipine use after SAH and no data about effect of the drug on vasospasm.

In this single-center, open-label, uncontrolled, pilot clinical study, the investigators hypothesize that clevidipine low-rate infusion will decrease sonographically-detected moderate cerebral vasospasm after aneurysmal SAH. The dose of the drug in this exploratory study is 2.5 to 5 times lower than the dose used previously to control BP. The effect of the drug will be evaluated in 20 patients by TCD monitoring during 3 periods: 1-hour pre-infusion, 4-hour infusion and 4-hour post infusion. The cerebral blood flow velocities, which are a surrogate marker of vasospasm, will be compared between the 3 periods. The primary efficacy end-point will be the percentage of measurements with at least a 10% or more decrease of the velocities during the infusion period. Potential long-term effects after discontinuation of the drug will be also evaluated in the post-infusion 4-hour period and beyond, until the last follow up. The major safety issue is hypotension induced by the drug during a period when vasospasm is present. For that reason, two measures will be taken. First, only patients with moderate vasospasm will be evaluated. Second, vasopressors will be used as needed during the infusion period to counteract the systemic circulatory effect of the drug and maintain a stable systemic Mean Arterial Pressure (MAP) within 10% range compared to pre-infusion. Potential effect of cerebral vasodilation on intracranial pressure (ICP) will be also evaluated during the infusion and post-infusion periods and any elevation > 10 mm Hg will be reported.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Subarachnoid Hemorrhage
  • Cerebral Aneurysm
  • Vasospasm, Intracranial
Intervention  ICMJE Drug: clevidipine
clevidipine infusion x4 hours
Other Name: Cleviprex
Study Arms  ICMJE Experimental: clevidipine
Four-hour infusion of low-dose intravenous clevidipine in patients with moderate vasospasm after aneurysmal subarachnoid hemorrhage
Intervention: Drug: clevidipine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 10, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02011321
Other Study ID Numbers  ICMJE HFHS-CLEVIDIPINE-PV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Panayiotis Varelas, Henry Ford Health System
Study Sponsor  ICMJE Henry Ford Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Panayiots Varelas, MD, PhD Henry Ford Health System
Study Director: Tamer Abdelhak, MD Henry Ford Health System
Study Director: Mohammed Rehman, DO Henry Ford Health System
PRS Account Henry Ford Health System
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP