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Completed

NCT Number: NCT02411266

Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage

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

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Key information

Conditions

Ischemic Preconditioning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: limb preconditioning

Primary outcomes

  1. Safety Outcomes 1 - number of patients who develop deep vein thrombosis and thromboembolism

    Time frame: 90 days

    The number of patients who develop deep vein thrombosis and thromboembolism in the treatment and control group.

  2. Safety Outcome 2 - number of patients who develop neurovascular injury

    Time frame: 90 days

    The number of patients who develop neurovascular injury in the treatment and control group.

  3. Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort

    Time frame: 90 days

    The number of patients who cannot tolerate the intervention due to discomfort.

  4. Safety Outcome 4 - number of patients with cardiovascular events

    Time frame: 90 days

    The number of patients with cardiovascular events [defined as hypotension, myocardial ischemia]

Other outcomes

  1. Clinical Outcome - number of patients with a good modified Rankin Scale, defined as less than 2

    Time frame: 90 days

    The number of patients with a good modified Rankin Scale, defined as less than 2, in the control and intervention group.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Acronym: PreLIMBS

Important dates

Study start
2008
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2015
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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