Using a special device to improve outcomes for stroke patients during helicopter transport

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the feasibility of remote limb ischemic conditioning (RLIC) in patients with acute ischemic stroke caused by large vessel occlusion while they are being transported by helicopter to a thrombectomy-capable center. Fifteen subjects will receive RLIC using the Doctormate device, which involves inflating blood pressure cuffs on both arms and legs for 5-minute cycles during transport. The study will monitor patients for side effects upon arrival at the comprehensive stroke center. The goal is to determine if this intervention can help preserve brain tissue during the critical transport period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 and ≤ 80 years
2. Suspected acute ischemic stroke with symptoms suggestive of large vessel occlusion (aphasia, agnosia, neglect, visual field cut, and gaze preference).
3. Patient screened for rtPA, and rtPA administered if eligible
4. Subject or legally authorized representative able to provide consent at the time of the assessment
5. NIHSS 6-20

Exclusion Criteria:

1. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) on CT scan at the community hospital
2. History of upper or lower extremity ischemia, known subclavian, brachial artery, iliac or femoral artery stenosis, subclavian steal syndrome, any upper or lower extremity soft tissue, orthopedic or vascular injury, or mastectomy or other procedure that may contraindicate taking blood pressure or having a cuff on the arm or leg for the conditioning treatment
3. History of diabetes mellitus
4. Enrollment in another clinical trial
5. Patient incarcerated
6. Pregnancy. Patients ages 18-55 will need to have a negative urine or blood based pregnancy test.
7. Agitation deemed unsafe for ischemic preconditioning testing.
8. Arteriovenous fistula in upper limb

Where it's running

• University of Iowa
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Enrique Leira, MD — University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242
• Study coordinator: Amir Shaban, MD
• Email: amir-shaban@uiowa.edu
• Phone: 3193568755

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.