Evidence map›Paper›PMID 35866431›Full record

ArticleArtificial organs2022

Comparison of animal and human blood for in vitro dynamic thrombogenicity testing of biomaterials.

Megan A Jamiolkowski, Mehulkumar Patel, Madelyn D Golding, Richard A Malinauskas, Qijin Lu

Open access · greenAbstract read
In one paragraph

Article in Artificial organs, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Article
  3. In Vitro Thrombogenicity Evaluation of Hemodialyzers.International journal of molecular sciences · 2026
    Article
  4. Article
  5. Article
  6. Molecular Biomarkers for In Vitro Thrombogenicity Assessment of Medical Device Materials.Journal of biomedical materials research. Part B, Applied biomaterials · 2024
    Article
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Megan A JamiolkowskiCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-5447-5621
Mehulkumar PatelCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-0218-593X
Madelyn D GoldingCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Richard A MalinauskasCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-5298-4502
Qijin LuCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-3004-9433
United States Food and Drug Administration · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

backgroundTo 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.

methodsTo 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.

resultsWhile 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.

conclusionsThese 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.

Indexed as

Biocompatible MaterialsThrombosisAnimalsCattleHeparinHumansLatexMaterials TestingPolyethylenePolytetrafluoroethyleneSheepSiliconesBiocompatible MaterialsHeparinLatexPolyethylenePolytetrafluoroethyleneSiliconesanimal blood sourcesblood flow loophuman bloodin vitro testingplateletsthrombogenicitythrombosis

Identifiers

PMID35866431
PMCPMC9669094
OpenAlexW4286716241

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.