PMID- 30807378
OWN - NLM
STAT- MEDLINE
DCOM- 20200914
LR  - 20230727
IS  - 1538-943X (Electronic)
IS  - 1058-2916 (Print)
IS  - 1058-2916 (Linking)
VI  - 66
IP  - 2
DP  - 2020 Feb
TI  - An In Vitro Blood Flow Loop System for Evaluating the Thrombogenicity of Medical 
      Devices and Biomaterials.
PG  - 183-189
LID - 10.1097/MAT.0000000000000958 [doi]
AB  - A reliable in vitro dynamic test method to evaluate device thrombogenicity is 
      very important for the improvement of the design and safety of blood-contacting 
      medical devices, while reducing the use of animal studies. In this study, a 
      recirculating flow loop system was developed for thrombogenicity testing, using 
      donor sheep blood anticoagulated with Anticoagulant Citrate Dextrose Solution A 
      (ACDA) and used within 24-36 hr postdraw. Immediately before testing, the blood 
      was recalcified and heparinized to a donor-specific target concentration. The 
      heparinization level was based on a static pretest, in which latex tubes were 
      incubated at room temperature for 30 min in blood with a series of heparin 
      concentrations and evaluated for thrombus deposition. For dynamic testing, blood 
      was recirculated at room temperature through a polyvinyl chloride (PVC) tubing 
      loop containing a test material for 1 hr at 200 ml/min using a roller pump. Nine 
      materials were investigated: a negative control (polytetrafluoroethylene [PTFE]), 
      a positive control (latex), and seven commonly used biomaterials including PVC, 
      two silicones with different formulations (Q-Sil and V-Sil), nylon, polyurethane 
      (PU), high-density polyethylene (HDPE), and polyether block amide (PEBAX). The 
      results showed that latex was significantly more thrombogenic than all the other 
      materials (p < 0.05), PVC and Q-Sil exhibited intermediate thrombogenicity with 
      significantly more thrombus surface coverage and thrombus weight than PTFE (p < 
      0.05), whereas PTFE and the rest of the biomaterials had little to no thrombus 
      deposition. In summary, the test loop system was able to effectively 
      differentiate materials with different thrombogenic potentials.
FAU - Jamiolkowski, Megan A
AU  - Jamiolkowski MA
AD  - From the U.S. Food and Drug Administration (FDA), Center for Devices and 
      Radiological Health (CDRH), Office of Science and Engineering Laboratories 
      (OSEL), Silver Spring, Maryland.
FAU - Hartung, Matthew C
AU  - Hartung MC
FAU - Malinauskas, Richard A
AU  - Malinauskas RA
FAU - Lu, Qijin
AU  - Lu Q
LA  - eng
GR  - FD999999/ImFDA/Intramural FDA HHS/United States
PT  - Journal Article
PL  - United States
TA  - ASAIO J
JT  - ASAIO journal (American Society for Artificial Internal Organs : 1992)
JID - 9204109
RN  - 0 (Biocompatible Materials)
SB  - IM
MH  - Animals
MH  - Biocompatible Materials/*adverse effects
MH  - Equipment Design/*methods
MH  - Hemodynamics/physiology
MH  - In Vitro Techniques/*methods
MH  - Sheep
MH  - Thrombosis/*etiology
PMC - PMC10370649
MID - NIHMS1914963
COIS- Disclosure: The authors have no conflicts of interest to report.
EDAT- 2019/02/27 06:00
MHDA- 2020/09/15 06:00
PMCR- 2023/07/26
CRDT- 2019/02/27 06:00
PHST- 2019/02/27 06:00 [pubmed]
PHST- 2020/09/15 06:00 [medline]
PHST- 2019/02/27 06:00 [entrez]
PHST- 2023/07/26 00:00 [pmc-release]
AID - 00002480-202002000-00012 [pii]
AID - 10.1097/MAT.0000000000000958 [doi]
PST - ppublish
SO  - ASAIO J. 2020 Feb;66(2):183-189. doi: 10.1097/MAT.0000000000000958.