Ischemic Conditioning During Air tRansport Save penUmbral Tissue

Обзор

The purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device used to perform RLIC, on patients with acute ischemic stroke due to large vessel occlusion being transported to a thrombectomy capable center by the helicopter.

Подробное описание

In this study, 15 subjects presenting to a community hospital with signs and symptoms of ischemic stroke due to large vessel occlusion, transported to a comprehensive stroke center by aircew will receive RLIC using the Doctormate device.

The RLIC treatment will consist of 3-5 cycles ( depending on transportation time) of 5 minutes inflations of both blood pressure cuffs simultaneously. Blood pressure will be 200 mm HG with 5 minutes of reperfusion between each inflation.

Subjects will be evaluated upon arrival to the comprehensive stroke center and evaluated for side effects.

The study will be conducted at one site ( University of Iowa Hospitals and Clinics)

Вмешательства

• Устройство Ischemic conditioning device
  RLIC will be done using a specialized blood pressure device ( Doctormate) that inflates to 200 mm HG for 5 minutes followed by 5 minutes deflation.

Первичные конечные точки

• Evaluate the feasibility of delivering RLIC by air medical crews in patients with AIS. This will be assessed by recording the number of cycles completed during transport. [Срок оценки: The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital]

Вторичные конечные точки (1)

• Assess adverse events related to performing RLIC in patients with large vessel occlusion. [Срок оценки: AEs will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.]

Критерии участия

Критерии включения

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

Критерии исключения

• Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) on CT scan at the community hospital
• 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
• History of diabetes mellitus
• Enrollment in another clinical trial
• Patient incarcerated
• Pregnancy. Patients ages 18-55 will need to have a negative urine or blood based pregnancy test.
• Agitation deemed unsafe for ischemic preconditioning testing.
• Arteriovenous fistula in upper limb

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• University of Iowa — Iowa City

Идентификаторы

NCT: NCT03481205 · 201712791

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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