An interventional study of ischemic conditioning group in Ischemic Preconditioning, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-13.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
The purpose of this study is to learn about protecting the brain from dangerous low blood flow.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
This study's enrollment of 57 is close to the median of 52 across 263 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects in this group will undergo sham preconditioning. A blood pressure cuff will be placed around the leg and inflated just lightly to a pressure of 30mmHg, not enough to affect arterial circulation. This will be maintained for 10min followed by 5min of deflation. This will constitute one conditioning cycle. There will be 3 sham conditioning cycles per treatment session.
Other: ischemic conditioning group
Study personnel will place a blood pressure cuff around the subject's leg and use it to interrupt the circulation to the leg for 10 minutes followed by release of the blood pressure for 5 minutes. This will be repeated for a total of 3 times every 24 to 48 hours up to 14 days. The cuff will be inflated for 10 minutes and then deflated for 5 minutes. There will be 3 cycles of this. The cuff will be inflated to 200mmHg to induce ischemia, confirmed by palpation of pedal pulses.
Other: ischemic conditioning group
application of a blood pressure cuff around a leg and inflating the cuff to 200mmHg to induce limb ischemia for 10min followed by 5min reperfusion. this will be done for 3 cycles every 24-48hours during the first 14 days after subarachnoid hemorrhage
Also known as: limb preconditioning
Safety Outcomes 1 - number of patients who develop deep vein thrombosis and thromboembolism
The number of patients who develop deep vein thrombosis and thromboembolism in the treatment and control group.
Time frame: 90 days
Safety Outcome 2 - number of patients who develop neurovascular injury
The number of patients who develop neurovascular injury in the treatment and control group.
Time frame: 90 days
Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort
The number of patients who cannot tolerate the intervention due to discomfort.
Time frame: 90 days
Safety Outcome 4 - number of patients with cardiovascular events
The number of patients with cardiovascular events \[defined as hypotension, myocardial ischemia\]
Time frame: 90 days
Clinical Outcome - number of patients with a good modified Rankin Scale, defined as less than 2
The number of patients with a good modified Rankin Scale, defined as less than 2, in the control and intervention group.
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University of Miami