Point-of-Care Diagnosis and Management of Trauma Patients by Acoustic Tweezing Coagulometry
N
Nathan Alves
Primary Investigator
Enrolling By Invitation
10 years - 100 years
All
Phase
N/A
150 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The overall goal of the funded proposal is to develop prototypes of a portable and deployable point-of-care comprehensive coagulation analyzer for diagnosis and management of coagulation abnormalities in trauma patients. The goal for the IU subaward is preliminary testing of the Levisonics’ coagulation device prototypes in trauma subjects at Methodist Hospital compared to standard of care clinical coagulation testing.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants will be identified from the ED tracking board in Cerner or by a designated trauma group in Diagnotes and recruited from the Methodist emergency department.
Detailed description of study
What will happen during the study?
- We will use a sample of blood that is drawn as part of the patient's medical care
- Participants will not undergo any additional procedures, and no further contact will be made with them by the study team.
- The collected blood sample will be analyzed on the Levisonics Acoustic Tweezing Coagulation device within 4 hours of the blood draw with analysis preference at <2 hrs following the draw. Coagulation assays will be run on the single tube of blood on the Levisonics device in the presence or absence of various clot activators or inhibitors. Second tube of blood will be used for a research TEG when necessary. Deidentified coagulation data will be stored on the device and then provided to Levisonics. The device produced data will not be available to the attending physician and will not be used in clinical decision-making regarding patient care in the ED. The device that coagulation testing will occur on is an early prototype and is not being considered for regulatory approval in its current form. This study is considered preclinical testing for device development and optimization.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Blood clotting, Coagulation abnormality
-
Age: 10 years - 100 years
-
Gender: All
Inclusion Criteria:
- Participants must be designated either Trauma 1 or Trauma 2 upon admission to the Emergency Department with the blood draw occurring within 24hr of arrival to the ED.
Updated on
10 Mar 2025.
Study ID: EMER-IIR-LEVISONICS-LATT, 24904
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