Preconditioning for Aneurismal Subarachnoid Hemorrhage

NCT01110239 | Completed Results DMC

• 1 other identifier: 20080406
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

In remote preconditioning, ischemia in one organ protects distant organs from ischemic insults. e.g. brief induced limb ischemia protects the brain from an otherwise more severe stroke. The objective of this study is to determine if remote ischemic preconditioning can be safely and effectively instituted in patients with subarachnoid hemorrhage, who are at high risk for developing disabling cerebral ischemia. The investigators will also preliminarily assess if there is evidence for neuroprotection. This will be a Phase 1b study. Additional objectives are:

1. 1.to determine if remote ischemic preconditioning can be safely and effectively instituted in patients with subarachnoid hemorrhage, who are at high risk for developing disabling cerebral ischemia.
2. 2.analogously to a dose-escalation study the investigators propose to study the safety and tolerability of increasing durations of limb ischemia until a target time of 10 minutes of limb ischemia has been reached.

Conditions

Subarachnoid Hemorrhage

Keywords

limb preconditioning; remote preconditioning; ischemic preconditioning

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Deep Vein Thrombosis for Safety Assessment.

  90 days

• Visual Analog Scale Score as a Measure of Tolerability

  The visual analogue scale is a pain scale from 0-10, with 10 being maximum pain and is frequently used in research studies assessing patient discomfort.

  90 days

Study Arms (1)

remote limb preconditioning

EXPERIMENTAL

Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.

Procedure: remote limb preconditioning

Interventions

remote limb preconditioning PROCEDURE

3 cycles of up to 10 minutes leg ischemia

Also known as: ischemic preconditioning

remote limb preconditioning

Eligibility Criteria

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

You may not qualify if:

• Hunt Hess Scale \> 4
• Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort.
• Inability to obtain informed consent from the patient or a health care proxy.
• Ankle-brachial index \< 0.7
• Inability to start limb preconditioning within 4 days of bleeding.

Sponsors & Collaborators

• University of Miami: lead

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Ischemic Preconditioning

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

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Sebastian Koch
• Organization: University Miami

skoch@med.miami.edu

305 243-6733

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 26, 2010
• Study Start: November 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 9, 2017
• Results First Posted: March 11, 2013

Record last verified: 2017-05