Remote Ischemic Preconditioning in Subarachnoid Hemorrhage

NCT01158508 | Completed Phase 1

• 1 other identifier: 09-08-081-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage, Aneurysmal; Subarachnoid Hemorrhage; Cerebral Vasospasm; Intracranial Aneurysm

Keywords

cerebral aneurysm; cerebral vasospasm; subarachnoid hemorrhage; remote ischemic preconditioning

Outcome Measures

Primary Outcomes (4)

• Occurrence of neurological events, or vasospasm

  At days 3

• Occurrence of neurological events, or vasospasm

  At day 7

• Occurrence of neurological events, or vasospasm

  At day 15

• Occurrence of neurological events, or vasospasm

  At day 30

Secondary Outcomes (3)

• Transcranial Doppler Measurements and metabolic assessment

  At days 3

• Transcranial Doppler Measurements and metabolic assessment

  At day 7

• Transcranial Doppler Measurements and metabolic assessment

  At day 15

Study Arms (1)

Remote Ischemic Preconditioning

EXPERIMENTAL

Patients with aneurysmal subarachnoid hemorrhage, after aneurysm treatment, will be given prophylactic remote ischemic preconditioning by transient lower limb ischemia.

Procedure: Remote ischemic preconditioning

Interventions

Remote ischemic preconditioning PROCEDURE

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.

Remote Ischemic Preconditioning

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• 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.

  PMID: 25072112 RESULT

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Aneurysm

Study Officials

• Nestor R Gonzalez, MD

  University of California, Los Angeles David Geffen School of Medicine, Departments of Neurosurgery and Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: July 8, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

US (1)