Effect of Temperature on Thrombogenicity Testing of Biomaterials in an In Vitro Dynamic Flow Loop System

Patel, Mehulkumar; Jamiolkowski, Megan A.; Vejendla, Anjali; Bentley, Viviana; Malinauskas, Richard A.; Lu, Qijin

doi:10.1097/mat.0000000000001897

Effect of Temperature on Thrombogenicity Testing of Biomaterials in an In Vitro Dynamic Flow Loop System

Journal Article · Sun Jan 01 04:00:00 EST 2023 · ASAIO Journal

DOI:https://doi.org/10.1097/mat.0000000000001897· OSTI ID:2425650

^[1]; ^[1]; Vejendla, Anjali ^[1]; Bentley, Viviana ^[1]; ^[1]; ^[1]

From the Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.

To develop and standardize a reliablein vitrodynamic thrombogenicity test protocol, the key test parameters that could impact thrombus formation need to be investigated and understood. In this study, we evaluated the effect of temperature on the thrombogenic responses (thrombus surface coverage, thrombus weight, and platelet count reduction) of various materials using anin vitroblood flow loop test system. Whole blood from live sheep and cow donors was used to assess four materials with varying thrombogenic potentials: negative-control polytetrafluoroethylene (PTFE), positive-control latex, silicone, and high-density polyethylene (HDPE). Blood, heparinized to a donor-specific concentration, was recirculated through a polyvinyl chloride tubing loop containing the test material at room temperature (22–24°C) for 1 hour, or at 37°C for 1 or 2 hours. The flow loop system could effectively differentiate a thrombogenic material (latex) from the other materials for both test temperatures and blood species (p< 0.05). However, compared with 37°C, testing at room temperature appeared to have slightly better sensitivity in differentiating silicone (intermediate thrombogenic potential) from the relatively thromboresistant materials (PTFE and HDPE,p< 0.05). These data suggest that testing at room temperature may be a viable option for dynamic thrombogenicity assessment of biomaterials and medical devices.

Research Organization:: Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN (United States)

Sponsoring Organization:: USDOE Office of Science (SC)

DOE Contract Number:: SC0014664

OSTI ID:: 2425650

Journal Information:: ASAIO Journal, Journal Name: ASAIO Journal Journal Issue: 6 Vol. 69; ISSN 1058-2916

Publisher:: American Society for Artificial Internal Organs

Country of Publication:: United States

Language:: English

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