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Search / Trial NCT03481205

Ischemic Conditioning During Air tRansport Save penUmbral Tissue

Launched by ENRIQUE LEIRA · Mar 21, 2018

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

Remote Limb Ischemic Conditioning Large Vessel Occlusion Helicopter Transport

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients experiencing an acute stroke caused by a blockage in a large blood vessel. The study aims to see if a special device, called the Doctormate, can help protect the brain tissue during air transport to a hospital that can provide more advanced treatment. This method is known as remote limb ischemic conditioning (RLIC), which involves temporarily restricting blood flow to a limb to improve blood flow to the brain.

To be eligible for this trial, participants need to be between 18 and 80 years old and show symptoms of a stroke, such as trouble speaking or seeing. They should also be assessed for a specific medication called rtPA, which helps dissolve blood clots, and able to provide consent for participation. If you or a loved one qualifies and decides to participate, you can expect to be safely monitored during air transport while receiving this innovative treatment aimed at preserving brain health during this critical time.

Gender

ALL

Eligibility criteria

  • 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

About Enrique Leira

Enrique Leira is a distinguished clinical trial sponsor with a robust background in advancing medical research across various therapeutic areas. With a commitment to improving patient outcomes, Leira leads innovative studies that focus on developing and evaluating cutting-edge treatments and interventions. Leveraging a collaborative approach, he engages with multidisciplinary teams to ensure rigorous study design, compliance with regulatory standards, and adherence to ethical practices. His dedication to fostering scientific excellence contributes to the generation of valuable data that informs clinical practice and enhances healthcare delivery.

Locations

Iowa City, Iowa, United States

Iowa City, Iowa, United States

Patients applied

0 patients applied

Trial Officials

Enrique Leira, MD

Principal Investigator

University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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