N/A
Completed N=34
Preconditioning for Aneurismal Subarachnoid Hemorrhage
Source: ClinicalTrials.gov NCT01110239 ↗Enrolled (actual)
34
Serious AEs
41.2%
Results posted
Mar 2013
Primary outcomePrimary: Number of Patients With Deep Vein Thrombosis for Safety Assessment. — 0; 3; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Deep Vein Thrombosis for Safety Assessment. |
0; 3; 0; 0 | — |
| PRIMARY Visual Analog Scale Score as a Measure of Tolerability |
0; 3.6; 1.8; 2.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01110239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.