Ischemic Conditioning During Air tRansport Save penUmbral Tissue
ConditionAcute Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEnrique Leira
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Ischemic conditioning device
DeviceRLIC will be done using a specialized blood pressure device ( Doctormate) that inflates to 200 mm HG for 5 minutes followed by 5 minutes deflation.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Ischemic ConditioningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
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.
Time frame
The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospitalSecondary outcomes
1
Assess adverse events related to performing RLIC in patients with large vessel occlusion.
We will collect data on adverse events, severe and serious adverse events during transport, at 24 hours of hospital admission as well as at the 3 months follow up visit. An intendent medical monitor will be designated to evaluate the reported serious and related adverse events
Time frame
AEs will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Enrique Leira
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov