Remote Ischemic Preconditioning in Subarachnoid Hemorrhage - Full Text View

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	Phase
Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm Intracranial Aneurysm	Procedure: Remote ischemic preconditioning	Phase 1


Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Aneurysms Bleeding

U.S. FDA Resources

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 ]
Occurrence of neurological events, or vasospasm [ Time Frame: At day 7 ]
Occurrence of neurological events, or vasospasm [ Time Frame: At day 15 ]
Occurrence of neurological events, or vasospasm [ Time Frame: At day 30 ]

Secondary Outcome Measures:

Transcranial Doppler Measurements and metabolic assessment [ Time Frame: At days 3 ]
Transcranial Doppler Measurements and metabolic assessment [ Time Frame: At day 7 ]
Transcranial Doppler Measurements and metabolic assessment [ Time Frame: At day 15 ]


Enrollment:	20
Study Start Date:	April 2010
Study Completion Date:	July 2014
Primary Completion Date:	January 2014 (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.

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Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

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

Locations


United States, California
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095

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

Publications:

Gonzalez NR, Connolly M, Dusick JR, Bhakta H, Vespa P. Phase I clinical trial for the feasibility and safety of remote ischemic conditioning for aneurysmal subarachnoid hemorrhage. Neurosurgery. 2014 Nov;75(5):590-8; discussion 598. doi: 10.1227/NEU.0000000000000514.


Responsible Party:	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:	November 23, 2016

Keywords provided by University of California, Los Angeles:


cerebral aneurysm cerebral vasospasm subarachnoid hemorrhage remote ischemic preconditioning

Additional relevant MeSH terms:


Aneurysm Intracranial Aneurysm Brain Diseases Hemorrhage Subarachnoid Hemorrhage Vasospasm, Intracranial Pathologic Processes	Vascular Diseases Cardiovascular Diseases Intracranial Hemorrhages Cerebrovascular Disorders Central Nervous System Diseases Nervous System Diseases Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on May 25, 2017

Remote Ischemic Preconditioning in Subarachnoid Hemorrhage (RIPC-SAH)