Subarachnoid Hemorrhage, Aneurysmal | Remote Ischemic Preconditioning in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Subarachnoid Hemorrhage, Aneurysmal
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Remote ischemic preconditioningTransient 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Remote Ischemic PreconditioningPatients with aneurysmal subarachnoid hemorrhage, after aneurysm treatment, will be given prophylactic remote ischemic preconditioning by transient lower limb ischemia.
Start Date: April 2010
Completed Date: July 2014
Phase: Phase 1
Primary Outcome: Occurrence of neurological events, or vasospasm
Secondary Outcome: Transcranial Doppler Measurements and metabolic assessment
Study sponsors, principal investigator, and references
Principal Investigator: Nestor R Gonzalez, MD
Lead Sponsor: University of California, Los Angeles
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.