Ischemic Preconditioning
Conditions
Brief summary
The purpose of this study is to learn about protecting the brain from dangerous low blood flow.
Interventions
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
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment. * Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate.
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. * Inability to precondition a leg that is not-plegic (that is preserved anti- gravity strength) and has not been accessed for catheter angiography * Age\<18 years * Pregnant women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcomes 1 - number of patients who develop deep vein thrombosis and thromboembolism | 90 days | The number of patients who develop deep vein thrombosis and thromboembolism in the treatment and control group. |
| Safety Outcome 2 - number of patients who develop neurovascular injury | 90 days | The number of patients who develop neurovascular injury in the treatment and control group. |
| Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort | 90 days | The number of patients who cannot tolerate the intervention due to discomfort. |
| Safety Outcome 4 - number of patients with cardiovascular events | 90 days | The number of patients with cardiovascular events \[defined as hypotension, myocardial ischemia\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome - number of patients with a good modified Rankin Scale, defined as less than 2 | 90 days | The number of patients with a good modified Rankin Scale, defined as less than 2, in the control and intervention group. |
Countries
United States
Outcome results
None listed