Remote Ischemic Preconditioning in Subarachnoid Hemorrhage (RIPC-SAH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Nestor R. Gonzalez, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01158508
First received: June 25, 2010
Last updated: March 24, 2013
Last verified: March 2013
  Purpose

Rupture of brain aneurysms is a common cause of death and disability, accounting for as many as 10% of stroke cases in the United States. While much of the resulting injury to the nervous system is caused by the initial bleeding from the aneurysm, many of these patients develop cerebral vasospasm, pathological constriction of the blood vessels supplying the brain, several days following hemorrhage. As many as a third of patients can suffer a resulting neurological deficit and stroke, presumably caused by the decreased blood flow to the brain (ischemia). This delayed brain injury accounts for a significant percentage of poor outcomes following aneurysm rupture. Studies have shown that remote ischemia to many organs can precondition other tissues (including the brain) to be more tolerant to decreases in blood flow. This "remote ischemic preconditioning" has the promise of protecting the brain from ischemic injury. Whereas in other forms of stroke the onset of ischemia cannot be predicted in the general population, following aneurysm rupture the investigators know which patients are likely to develop vasospasm and when. Therefore, ischemic preconditioning following aneurysm rupture may help prevent some of the ischemic injury caused by vasospasm. Remote ischemic preconditioning by transient limb ischemia (produced by inflation of a blood pressure cuff on the arm or leg) has been shown to minimize injury to other organs, most notably the heart. Remote ischemic preconditioning of the brain following aneurysm rupture has not yet been investigated.


Condition Intervention
Subarachnoid Hemorrhage, Aneurysmal
Subarachnoid Hemorrhage
Cerebral Vasospasm
Intracranial Aneurysm
Procedure: Remote ischemic preconditioning

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prophylactic Remote Ischemic Preconditioning for Cerebral Vasospasm Following Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Occurrence of neurological events, or vasospasm [ Time Frame: At days 3 ] [ Designated as safety issue: No ]
  • Occurrence of neurological events, or vasospasm [ Time Frame: At day 7 ] [ Designated as safety issue: No ]
  • Occurrence of neurological events, or vasospasm [ Time Frame: At day 15 ] [ Designated as safety issue: No ]
  • Occurrence of neurological events, or vasospasm [ Time Frame: At day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transcranial Doppler Measurements and metabolic assessment [ Time Frame: At days 3 ] [ Designated as safety issue: No ]
  • Transcranial Doppler Measurements and metabolic assessment [ Time Frame: At day 7 ] [ Designated as safety issue: No ]
  • Transcranial Doppler Measurements and metabolic assessment [ Time Frame: At day 15 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote Ischemic Preconditioning
Patients with aneurysmal subarachnoid hemorrhage, after aneurysm treatment, will be given prophylactic remote ischemic preconditioning by transient lower limb ischemia.
Procedure: Remote ischemic preconditioning
Transient lower limb ischemia will be induced by inflation of a blood pressure cuff on the thigh. Four five minute cycles of ischemia will be performed, each followed by five minutes of reperfusion with the cuff down. This procedure will be performed in four rounds, typically on post-hemorrhage days 2, 3, 6 and 9.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of recent aneurysmal subarachnoid hemorrhage.
  • Definitive treatment of the aneurysm by surgical clipping or endovascular coiling has been completed.

Exclusion Criteria:

  • Patients with unprotected (untreated) cerebral aneurysms.
  • Patients with a known history of lower limb vascular disease, lower limb vascular bypass surgery and/or peripheral neuropathy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158508

Contacts
Contact: Nestor R Gonzalez, MD 310-825-5154 ngonzalez@mednet.ucla.edu
Contact: Joshua R Dusick, MD 323-825-5154 jdusick@mednet.ucla.edu

Locations
United States, California
UCLA Ronald Reagan Medical Center Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Nestor R Gonzalez, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Nestor R Gonzalez, MD University of California, Los Angeles David Geffen School of Medicine, Departments of Neurosurgery and Radiology
  More Information

No publications provided

Responsible Party: Nestor R. Gonzalez, Assistant Professor of Neurosurgery and Radiology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01158508     History of Changes
Other Study ID Numbers: 09-08-081-01
Study First Received: June 25, 2010
Last Updated: March 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
cerebral aneurysm
cerebral vasospasm
subarachnoid hemorrhage
remote ischemic preconditioning

Additional relevant MeSH terms:
Intracranial Aneurysm
Aneurysm
Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014