Blood Damage Models – Hemolysis

Objective:

The goal of this project is to generate regulatory-grade data using an experimental system that can 1) Measure hemolysis at a high level of precision and with multi-laboratory reproducibility 2) Investigate the effects of hematocrit on hemolysis severity and 3) Compare hemolysis severity of animal and human blood under similar conditions.

Benefits of this work (with respect to the MDIC mission)

This project will provide foundational gold-standard data that currently does not exist in the public domain.  This data will help medical device developers understand and reduce hemolysis during product development. Ultimately, this will benefit the patient by enhancing medical device and technology evaluation. This work stream will feed into a subsequent effort to develop predictive computational models of hemolysis.

Broad stakeholder engagement plan (dissemination beyond MDIC members)

During project planning stages, the group will solicit feedback from industry and subject matter experts through the MDIC.  Through MDIC, the group will also solicit participation in a multi-site study.  After completion of the work stream, the group will publish experimental details, protocols, blood-handling-procedures and results in peer-reviewed scientific journals, conferences, and/or other venues (e.g., public database library) to ensure scientific rigor, industry awareness, and broad access.

Deliverables:

Detailed description of blood collection and blood-handling experimental protocols, experimental system set-up, and report documenting results of the multi-site study including blood hematocrit levels, plasma-free hemoglobin levels, total blood hemoglobin, and estimate of shear stress history.

IP Considerations:

No attempt will be made to reverse engineer any devices/materials supplied by industry partners for the purpose of this project.