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Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

Primary Purpose

Subarachnoid Hemorrhage

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Simvastatin, 80 mg/day for 21 days
placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring subarachnoid hemorrhage, vasospasm, cerebral blood flow, cerebral metabolism, autoregulation, statin, Vasospasm associated with Subarachnoid hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18
  • SAH from ruptured cerebral aneurysm within 48 hours of admission.
  • Modified Fisher grade 2,3,or 4
  • Planned surgical or endovascular aneurysm repair

Exclusion Criteria:

  • Pregnancy
  • SAH secondary to traumatic or mycotic aneurysms
  • Pre-ictal statin therapy
  • Contraindication to stain therapy
  • WFNS grade 5
  • Contraindications to MAP elevation on day 7-10

Sites / Locations

  • Washington Univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Simvastatin, 80 mg/day

Placebo

Arm Description

Simvastatin, 80 mg/day for 21 days

Placebo

Outcomes

Primary Outcome Measures

Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk
Resting cerebral blood flow during peak period of vasospasm risk measured by PET
Cerebral Autoregulation During Peak Period of Vasospasm Risk
Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.

Secondary Outcome Measures

Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk
Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.

Full Information

First Posted
November 20, 2008
Last Updated
February 23, 2016
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00795288
Brief Title
Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)
Official Title
Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design.
Detailed Description
We will determine if statin therapy improves CBF in patients with aneurysmal subarachnoid hemorrhage. This improvement, if present, may be due to improved basal CBF, improved autoregulatory function, or a mitigation of large arterial narrowing. The information gain from this study will help us to better understand the mechanism of action of statins. This knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
Keywords
subarachnoid hemorrhage, vasospasm, cerebral blood flow, cerebral metabolism, autoregulation, statin, Vasospasm associated with Subarachnoid hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin, 80 mg/day
Arm Type
Experimental
Arm Description
Simvastatin, 80 mg/day for 21 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Simvastatin, 80 mg/day for 21 days
Other Intervention Name(s)
Simvastatin
Intervention Description
Active treatment group
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Control group
Primary Outcome Measure Information:
Title
Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk
Description
Resting cerebral blood flow during peak period of vasospasm risk measured by PET
Time Frame
7-10 days after hemorrhage
Title
Cerebral Autoregulation During Peak Period of Vasospasm Risk
Description
Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.
Time Frame
7-10 days after hemorrhage
Secondary Outcome Measure Information:
Title
Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk
Description
Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.
Time Frame
7-10 days after hemorrhage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 SAH from ruptured cerebral aneurysm within 48 hours of admission. Modified Fisher grade 2,3,or 4 Planned surgical or endovascular aneurysm repair Exclusion Criteria: Pregnancy SAH secondary to traumatic or mycotic aneurysms Pre-ictal statin therapy Contraindication to stain therapy WFNS grade 5 Contraindications to MAP elevation on day 7-10
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Diringer, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Univeristy
City
ST Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26721259
Citation
Diringer MN, Dhar R, Scalfani M, Zazulia AR, Chicoine M, Powers WJ, Derdeyn CP. Effect of High-Dose Simvastatin on Cerebral Blood Flow and Static Autoregulation in Subarachnoid Hemorrhage. Neurocrit Care. 2016 Aug;25(1):56-63. doi: 10.1007/s12028-015-0233-7.
Results Reference
result

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Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

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