Evidence map›Paper›PMID 30807378›Full record

ArticleASAIO journal (American Society for Artificial Internal Organs : 1992)2020

An In Vitro Blood Flow Loop System for Evaluating the Thrombogenicity of Medical Devices and Biomaterials.

Megan A Jamiolkowski, Matthew C Hartung, Richard A Malinauskas, Qijin Lu

Abstract read
In one paragraph

Article in ASAIO journal (American Society for Artificial Internal Organs : 1992), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
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

13 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Molecular Biomarkers for In Vitro Thrombogenicity Assessment of Medical Device Materials.Journal of biomedical materials research. Part B, Applied biomaterials · 2024
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. 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

4 authors.

Megan A JamiolkowskiFrom 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.
Matthew C Hartung
Richard A Malinauskas
Qijin Lu

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

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.

Indexed as

AnimalsBiocompatible MaterialsEquipment DesignHemodynamicsIn Vitro TechniquesSheepThrombosisBiocompatible Materials

Identifiers

PMID30807378
PMCPMC10370649

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Registered trials

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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.