Preconditioning for Aneurismal Subarachnoid Hemorrhage

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sebastian Koch, University of Miami
ClinicalTrials.gov Identifier:
NCT01110239
First received: April 21, 2010
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Subarachnoid Hemorrhage
Procedure: remote limb preconditioning
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurismal Subarachnoid Hemorrhage

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Number of Patients With Deep Vein Thrombosis for Safety Assessment. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Visual Analog Scale Score as a Measure of Tolerability [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 34
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Sebastian Koch, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01110239     History of Changes
Other Study ID Numbers: 20080406
Study First Received: April 21, 2010
Results First Received: August 9, 2011
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
limb preconditioning
remote preconditioning
ischemic preconditioning

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

ClinicalTrials.gov processed this record on April 16, 2014