Remote Ischemic Preconditioning in Subarachnoid Hemorrhage (RIPC-SAH)
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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 |
- 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 ]
- 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.
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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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Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Nestor R Gonzalez, MD | 310-825-5154 | ngonzalez@mednet.ucla.edu |
| Contact: Joshua R Dusick, MD | 323-825-5154 | jdusick@mednet.ucla.edu |
| United States, California | |
| UCLA Ronald Reagan Medical Center | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Principal Investigator: Nestor R Gonzalez, MD | |
| 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:
|
Aneurysm Intracranial Aneurysm Hemorrhage Subarachnoid Hemorrhage Vasospasm, Intracranial Vascular Diseases Cardiovascular Diseases |
Intracranial Arterial Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pathologic Processes Intracranial Hemorrhages |
ClinicalTrials.gov processed this record on June 18, 2013