Clinical trial NCT03481205: Ischemic Conditioning During Air tRansport Save penUmbral Tissue
Official title: Ischemic Conditioning During Air tRansport Save penUmbral Tissue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Stroke
Keywords: remote limb ischemic conditioning
large vessel occlusion
helicopter transport
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: 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)

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

Primary outcomes:
measure: 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.
timeFrame: The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital
Secondary outcomes:
measure: Assess adverse events related to performing RLIC in patients with large vessel occlusion.
timeFrame: AEs will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242
name: Enrique Leira, MD
role: PRINCIPAL_INVESTIGATOR
References: