PMID- 35866431
OWN - NLM
STAT- MEDLINE
DCOM- 20221121
LR  - 20230802
IS  - 1525-1594 (Electronic)
IS  - 0160-564X (Print)
IS  - 0160-564X (Linking)
VI  - 46
IP  - 12
DP  - 2022 Dec
TI  - Comparison of animal and human blood for in vitro dynamic thrombogenicity testing 
      of biomaterials.
PG  - 2400-2411
LID - 10.1111/aor.14366 [doi]
AB  - BACKGROUND: To determine suitable alternatives to human blood for in vitro 
      dynamic thrombogenicity testing of biomaterials, four different animal blood 
      sources (ovine, bovine, and porcine blood from live donors, and abattoir porcine 
      blood) were compared to fresh human blood. METHODS: To account for blood 
      coagulability differences between individual donors and species, each blood pool 
      was heparinized to a donor-specific concentration immediately before testing in a 
      dynamic flow loop system. The target heparin level was established using a static 
      thrombosis pre-test. For dynamic testing, whole blood was recirculated at room 
      temperature for 1 h at 200 ml/min through a flow loop containing a single test 
      material. Four materials with varying thrombotic potentials were investigated: 
      latex (positive control), polytetrafluoroethylene (PTFE) (negative control), 
      silicone (intermediate thrombotic potential), and high-density polyethylene 
      (HDPE) (historically thromboresistant). Thrombus weight and surface area coverage 
      on the test materials were quantified, along with platelet count reduction in the 
      blood. RESULTS: While donor-specific heparin levels varied substantially from 
      0.6 U/ml to 7.0 U/ml among the different blood sources, each source was able to 
      differentiate between the thrombogenic latex and the thromboresistant PTFE and 
      HDPE materials (p < 0.05). However, only donor ovine and bovine blood were 
      sensitive enough to differentiate an increased response for the intermediate 
      thrombotic silicone material compared to PTFE and HDPE. CONCLUSIONS: These 
      results demonstrated that multiple animal blood sources (particularly donor ovine 
      and bovine blood) may be suitable alternatives to fresh human blood for dynamic 
      thrombogenicity testing when appropriate control materials and donor-specific 
      anticoagulation levels are used.
CI  - Published 2022. This article is a U.S. Government work and is in the public 
      domain in the USA.
FAU - Jamiolkowski, Megan A
AU  - Jamiolkowski MA
AUID- ORCID: 0000-0002-5447-5621
AD  - Center for Devices and Radiological Health, U.S. Food and Drug Administration, 
      Silver Spring, Maryland, USA.
FAU - Patel, Mehulkumar
AU  - Patel M
AUID- ORCID: 0000-0002-0218-593X
AD  - Center for Devices and Radiological Health, U.S. Food and Drug Administration, 
      Silver Spring, Maryland, USA.
FAU - Golding, Madelyn D
AU  - Golding MD
AD  - Center for Devices and Radiological Health, U.S. Food and Drug Administration, 
      Silver Spring, Maryland, USA.
FAU - Malinauskas, Richard A
AU  - Malinauskas RA
AUID- ORCID: 0000-0002-5298-4502
AD  - Center for Devices and Radiological Health, U.S. Food and Drug Administration, 
      Silver Spring, Maryland, USA.
FAU - Lu, Qijin
AU  - Lu Q
AUID- ORCID: 0000-0002-3004-9433
AD  - Center for Devices and Radiological Health, U.S. Food and Drug Administration, 
      Silver Spring, Maryland, USA.
LA  - eng
GR  - FD999999/ImFDA/Intramural FDA HHS/United States
PT  - Journal Article
DEP - 20220730
PL  - United States
TA  - Artif Organs
JT  - Artificial organs
JID - 7802778
RN  - 0 (Biocompatible Materials)
RN  - 9005-49-6 (Heparin)
RN  - 0 (Latex)
RN  - 9002-88-4 (Polyethylene)
RN  - 9002-84-0 (Polytetrafluoroethylene)
RN  - 0 (Silicones)
SB  - IM
MH  - Animals
MH  - Cattle
MH  - Humans
MH  - *Biocompatible Materials/adverse effects
MH  - Heparin/blood
MH  - Latex/adverse effects
MH  - Materials Testing/methods
MH  - Polyethylene/adverse effects
MH  - Polytetrafluoroethylene/adverse effects
MH  - Sheep
MH  - Silicones/adverse effects
MH  - *Thrombosis/etiology
PMC - PMC9669094
MID - NIHMS1825322
OTO - NOTNLM
OT  - animal blood sources
OT  - blood flow loop
OT  - human blood
OT  - in vitro testing
OT  - platelets
OT  - thrombogenicity
OT  - thrombosis
EDAT- 2022/07/23 06:00
MHDA- 2022/11/18 06:00
PMCR- 2023/07/31
CRDT- 2022/07/22 05:05
PHST- 2022/06/16 00:00 [revised]
PHST- 2022/04/25 00:00 [received]
PHST- 2022/07/11 00:00 [accepted]
PHST- 2022/07/23 06:00 [pubmed]
PHST- 2022/11/18 06:00 [medline]
PHST- 2022/07/22 05:05 [entrez]
PHST- 2023/07/31 00:00 [pmc-release]
AID - 10.1111/aor.14366 [doi]
PST - ppublish
SO  - Artif Organs. 2022 Dec;46(12):2400-2411. doi: 10.1111/aor.14366. Epub 2022 Jul 
      30.