Preconditioning for Aneurismal Subarachnoid Hemorrhage
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | November 2008 |
| End Date: | June 2010 |
| Contact: | Sebastian Koch, MD |
| Email: | skoch@med.miami.edu |
| Phone: | 305 243 6733 |
Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurismal Subarachnoid Hemorrhage
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.
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.
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.
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