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Trial record 10 of 194 for:    Hemorrhage AND SAH

Remote Ischemic Preconditioning in Subarachnoid Hemorrhage (RIPC-SAH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01158508
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : November 28, 2016
Information provided by (Responsible Party):
University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment Phase
Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm Intracranial Aneurysm Procedure: Remote ischemic preconditioning Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prophylactic Remote Ischemic Preconditioning for Cerebral Vasospasm Following Subarachnoid Hemorrhage
Study Start Date : April 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Bleeding

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Occurrence of neurological events, or vasospasm [ Time Frame: At days 3 ]
  2. Occurrence of neurological events, or vasospasm [ Time Frame: At day 7 ]
  3. Occurrence of neurological events, or vasospasm [ Time Frame: At day 15 ]
  4. Occurrence of neurological events, or vasospasm [ Time Frame: At day 30 ]

Secondary Outcome Measures :
  1. Transcranial Doppler Measurements and metabolic assessment [ Time Frame: At days 3 ]
  2. Transcranial Doppler Measurements and metabolic assessment [ Time Frame: At day 7 ]
  3. Transcranial Doppler Measurements and metabolic assessment [ Time Frame: At day 15 ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01158508

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

Publications of Results:
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Responsible Party: University of California, Los Angeles Identifier: NCT01158508     History of Changes
Other Study ID Numbers: 09-08-081-01
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016

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

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