Using a special device to improve outcomes for stroke patients during helicopter transport
Ischemic Conditioning During Air tRansport Save penUmbral Tissue
This study is testing whether a special device that uses blood pressure cuffs can help protect the brains of stroke patients during their helicopter transport to a hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT03481205 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of remote limb ischemic conditioning (RLIC) in patients with acute ischemic stroke caused by large vessel occlusion while they are being transported by helicopter to a thrombectomy-capable center. Fifteen subjects will receive RLIC using the Doctormate device, which involves inflating blood pressure cuffs on both arms and legs for 5-minute cycles during transport. The study will monitor patients for side effects upon arrival at the comprehensive stroke center. The goal is to determine if this intervention can help preserve brain tissue during the critical transport period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with suspected acute ischemic stroke due to large vessel occlusion.
Not a fit: Patients with a history of diabetes mellitus or those with contraindications for blood pressure cuff use will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the preservation of brain tissue in stroke patients, potentially improving their recovery outcomes.
How similar studies have performed: While the approach of remote limb ischemic conditioning is promising, this specific application during air transport is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Enrique Leira, MD — University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242
- Study coordinator: Amir Shaban, MD
- Email: amir-shaban@uiowa.edu
- Phone: 3193568755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.