Preconditioning for Aneurismal Subarachnoid Hemorrhage

• ClinicalTrials.gov Identifier: NCT01110239
• Recruitment Status: Completed
• First Posted: April 26, 2010
• Results First Posted: March 11, 2013
• Last Update Posted: June 9, 2017
• Sponsor: University of Miami
• Information provided by (Responsible Party): Sebastian Koch, University of Miami

Study Description

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. 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. 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.

Condition or disease	Intervention/treatment	Phase
Subarachnoid Hemorrhage	Procedure: remote limb preconditioning	Not Applicable

Detailed Description:

The investigators propose to study patients with subarachnoid hemorrhage, who generally have a high risk of ischemic stroke in the 2 weeks following the initial bleed, and patients with clipped or coiled aneurysm. The investigators will apply a blood pressure cuff around leg and use it to interrupt the circulation for 5-10 minutes. The investigators will repeat this for a total of 3 times every 24 to 48 hours up to 14 days. The cuff will be inflated for 5-10 minutes and then deflated for 5 minutes. There will be 3 cycles of this. The cuff will be inflated to 200mmHg.

The investigators will first start with 5 minutes of cuff inflation to either the arm or leg. The investigators will determine if this is safe in at least 6 patients. The investigators will then increase the duration of cuff inflation to 7.5 minutes for another 6 patients. If no adverse events are noted the investigators will the proceed to study 10 minutes of inflation in another 6 patients. If no side effects are noted the investigators will then determine that this is well tolerated.

The study will be monitored by a Data Safety Monitoring Board who will make decisions about escalating the duration of cuff inflation. If 2 or more patients develop an adverse event that is related to the procedure the investigators will stop and no longer continue at that level of cuff inflation and the previous level of cuff inflation will be determined to be the safe and tolerated level.

The investigators will collect safety data on adverse events such as tolerability, local tissue trauma or deep vein thrombosis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurismal Subarachnoid Hemorrhage
• Study Start Date: November 2008
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: remote limb preconditioning; 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; 3 cycles of up to 10 minutes leg ischemia; Other Name: ischemic preconditioning

Outcome Measures

Primary Outcome Measures :

1. Number of Patients With Deep Vein Thrombosis for Safety Assessment. [ Time Frame: 90 days ]
2. Visual Analog Scale Score as a Measure of Tolerability [ Time Frame: 90 days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: aneurismal subarachnoid hemorrhage

Exclusion Criteria:

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Sebastian Koch, Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT01110239
• Other Study ID Numbers: 20080406
• First Posted: April 26, 2010
• Results First Posted: March 11, 2013
• Last Update Posted: June 9, 2017
• Last Verified: May 2017

Keywords provided by Sebastian Koch, University of Miami:

limb preconditioning; remote preconditioning; ischemic preconditioning

Additional relevant MeSH terms:

Subarachnoid Hemorrhage; Hemorrhage; Pathologic Processes; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases