A Study to Evaluate a Multiplex Precision Medicine System for Early Warning of Progression Toward Shock After Trauma
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-005841
Sponsor Protocol Number: 19-005841
About this study
The purpose of this study is to evaluate performance of already developed porcine algorithms in the human “models” of lower body negative pressure (LBNP), and to obtain human model training and validation data sets from LBNP for further refinement of the algorithms.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subjects between 18-55 years of age.
- Non-obese (BMI < 30).
- Non-smokers.
- Free of any systemic diseases including hypertension, diabetes, coronary artery disease, neurologic disease, or any other major medical co-morbidity.
- All inclusion/exclusion criteria will be at the discretion of the Principal Investigator.
- Women will be either surgically sterilized or non-pregnant as determined by a urine pregnancy test.
- Urine pregnancy tests will be completed within 48 hours of any study intervention. If the test is positive they will not be able to participate in the study.
Exclusion Criteria:
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Michael Joyner, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available