Ischemic Conditioning During Air tRansport Save penUmbral Tissue (NCT03481205) | Clinical Trial Compass
RecruitingNot Applicable
Ischemic Conditioning During Air tRansport Save penUmbral Tissue
United States10 participantsStarted 2020-06-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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.
What they're measuring
1
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