Evidence map›Paper›PMID 39221585›Full record

ArticleArtificial organs2025

Development of a large diameter in vitro flow loop thrombogenicity test system.

Carlos Serna, Anna Parrish, Mehulkumar Patel, Keerthana Srinivasan, Richard Malinauskas, Qijin Lu, Megan Jamiolkowski

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Artificial organs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

7 authors.

Carlos SernaCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Anna ParrishCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Mehulkumar PatelCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Keerthana SrinivasanCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Richard MalinauskasCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
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
Megan JamiolkowskiCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0002-5447-5621

Funding

Critical Path Program, FDA, Center for Devices and Radiological HealthIntramural FDA HHS FD999999
6 · The paper itself

Abstract

backgroundTo accommodate a wider range of medical device sizes, a larger in vitro flow loop thrombogenicity test system using 9.5 -mm inner diameter (ID) tubing was developed and evaluated based on our previously established 6.4 -mm ID tubing system.

methodsFour cardiopulmonary bypass roller pumps were used concurrently to drive four flow loops during testing. To ensure that each pump produced a consistent thrombogenic response for the same material under the same test conditions, a novel dynamic roller occlusion setting method was applied. Five materials with varying thrombogenic potentials were tested: polytetrafluoroethylene (PTFE), silicone, 3D-printed nylon, latex, and nitrile rubber (BUNA). Day-old bovine blood was heparinized to a donor-specific concentration and recirculated through the flow loops containing test materials at 20 rpm for 1 h at room temperature. Material thrombogenicity was characterized by measuring the thrombus surface coverage, thrombus weight, and platelet (PLT) count reduction.

resultsThe larger tubing system can differentiate thrombogenic materials (latex, BUNA) from the thromboresistant PTFE material. Additionally, silicone and the 3D-printed nylon exhibited an intermediate thrombogenic response with significantly less thrombus surface coverage and PLT count reduction than latex and BUNA but more thrombus surface coverage than PTFE (p < 0.05).

conclusionThe 9.5 -mm ID test system can effectively differentiate materials of varying thrombogenic potentials when appropriate pump occlusion settings and donor-specific anticoagulation are used. This system is being assessed in an interlaboratory study to develop standardized best practices for performing in vitro dynamic thrombogenicity testing of medical devices and materials.

Indexed as

Equipment DesignMaterials TestingThrombosisAnimalsCardiopulmonary BypassCattlePlatelet CountPolytetrafluoroethylenePrinting, Three-DimensionalPolytetrafluoroethylenebiomaterialsblood flow loopin vitro testingocclusion settingplateletsroller pumpsthrombosis

Identifiers

PMID39221585
PMCPMC11693479

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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.