Preconditioning for Aneurismal Subarachnoid Hemorrhage
Primary Purpose
Subarachnoid Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
remote limb preconditioning
Sponsored by
About this trial
This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring limb preconditioning, remote preconditioning, ischemic preconditioning
Eligibility Criteria
Inclusion Criteria: aneurismal subarachnoid hemorrhage
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
remote limb preconditioning
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Patients With Deep Vein Thrombosis for Safety Assessment.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01110239
Brief Title
Preconditioning for Aneurismal Subarachnoid Hemorrhage
Official Title
Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurismal Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
Yes
5. 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:
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
Keywords
limb preconditioning, remote preconditioning, ischemic preconditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
remote limb preconditioning
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
remote limb preconditioning
Other Intervention Name(s)
ischemic preconditioning
Intervention Description
3 cycles of up to 10 minutes leg ischemia
Primary Outcome Measure Information:
Title
Number of Patients With Deep Vein Thrombosis for Safety Assessment.
Time Frame
90 days
Title
Visual Analog Scale Score as a Measure of Tolerability
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aneurismal subarachnoid hemorrhage
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Preconditioning for Aneurismal Subarachnoid Hemorrhage
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