Ischemic Conditioning During Air tRansport Save penUmbral Tissue
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ischemic Conditioning
Doctormate device used en route to the comprehensive stroke center
干预措施: Ischemic conditioning device (Device)
结局指标
主要结局
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.
时间窗: The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital
Feasibility will be assessed based on the number of cycles performed during transportation by air as follows: For flight time of duration of ≥ 60 minutes, ≥ 60% of subjects should receive 4 cycles of RLIC. For flight time of duration of 30-60 minutes, ≥ 60% of subjects should receive at least 3 cycles of RLIC. For flight duration of \< 30 minutes, ≥60% of subjects should receive at least 2 cycle of RLIC.
次要结局
- Assess adverse events related to performing RLIC in patients with large vessel occlusion.(AEs will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.)
研究者
Enrique Leira
Professor of Neurology
University of Iowa