Ischemic Conditioning During Air tRansport Save penUmbral Tissue

Overview

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)

Interventions

• Device 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.

Primary outcome measures

• 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. [Time frame: The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital]

Secondary outcome measures (1)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

United States · 1 center

• University of Iowa — Iowa City

Identifiers

NCT: NCT03481205 · 201712791

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗