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The purpose of this study is to learn about protecting the brain from dangerous low blood flow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Placebo Comparator | 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. |
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| treatment group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ischemic conditioning group | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 90 days |
| Safety Outcome 4 - number of patients with cardiovascular events | The number of patients with cardiovascular events [defined as hypotension, myocardial ischemia] | 90 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Koch, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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