PMID- 36848878
OWN - NLM
STAT- MEDLINE
DCOM- 20230605
LR  - 20230821
IS  - 1538-943X (Electronic)
IS  - 1058-2916 (Print)
IS  - 1058-2916 (Linking)
VI  - 69
IP  - 6
DP  - 2023 Jun 1
TI  - Effect of Temperature on Thrombogenicity Testing of Biomaterials in an In Vitro 
      Dynamic Flow Loop System.
PG  - 576-582
LID - 10.1097/MAT.0000000000001897 [doi]
AB  - To develop and standardize a reliable in vitro dynamic 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 an in vitro 
      blood 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 degrees C) for 1 hour, or at 37 degrees 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 degrees 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.
CI  - Copyright (c) ASAIO 2023.
FAU - Patel, Mehulkumar
AU  - Patel M
AUID- ORCID: 0000-0002-0218-593
AD  - 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.
FAU - Jamiolkowski, Megan A
AU  - Jamiolkowski MA
AUID- ORCID: 0000-0002-5447-5621
FAU - Vejendla, Anjali
AU  - Vejendla A
FAU - Bentley, Viviana
AU  - Bentley V
FAU - Malinauskas, Richard A
AU  - Malinauskas RA
AUID- ORCID: 0000-0002-5298-4502
FAU - Lu, Qijin
AU  - Lu Q
AUID- ORCID: 0000-0002-3004-9433
LA  - eng
GR  - FD999999/ImFDA/Intramural FDA HHS/United States
PT  - Journal Article
PT  - Research Support, U.S. Gov't, Non-P.H.S.
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20230227
PL  - United States
TA  - ASAIO J
JT  - ASAIO journal (American Society for Artificial Internal Organs : 1992)
JID - 9204109
RN  - 0 (Biocompatible Materials)
RN  - 9002-88-4 (Polyethylene)
RN  - 0 (Latex)
RN  - 0 (Silicones)
RN  - 9002-84-0 (Polytetrafluoroethylene)
SB  - IM
MH  - Female
MH  - Cattle
MH  - Animals
MH  - Sheep
MH  - *Biocompatible Materials/adverse effects
MH  - Temperature
MH  - Polyethylene
MH  - Latex
MH  - *Thrombosis/etiology
MH  - Silicones
MH  - Polytetrafluoroethylene/adverse effects
MH  - Materials Testing
PMC - PMC10368176
MID - NIHMS1916064
COIS- Disclosure: The authors have no conflicts of interest to report.
EDAT- 2023/02/28 06:00
MHDA- 2023/06/05 06:42
PMCR- 2023/07/25
CRDT- 2023/02/27 18:47
PHST- 2023/06/05 06:42 [medline]
PHST- 2023/02/28 06:00 [pubmed]
PHST- 2023/02/27 18:47 [entrez]
PHST- 2023/07/25 00:00 [pmc-release]
AID - 00002480-202306000-00009 [pii]
AID - 10.1097/MAT.0000000000001897 [doi]
PST - ppublish
SO  - ASAIO J. 2023 Jun 1;69(6):576-582. doi: 10.1097/MAT.0000000000001897. Epub 2023 
      Feb 27.