Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage

Ischemic Preconditioning Clinical Trial

— PreLIMBS  

Official title:

Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurysmal Subarachnoid Hemorrhage: a Safety and Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411266
• Other study ID #: 2008 0406 II
• Status: Completed
• Phase: N/A
• Start date: July 30, 2008
• Est. completion date: December 8, 2020

Study information

• Verified date: September 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn about protecting the brain from dangerous low blood flow.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 8, 2020
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Ischemia
• Ischemic Preconditioning
• Subarachnoid Hemorrhage

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	Safety Outcome 4 - number of patients with cardiovascular events	The number of patients with cardiovascular events [defined as hypotension, myocardial ischemia]	90 days