Evidence map›Paper›PMID 34431015›Full record

ArticleAnnals of biomedical engineering2021

Validation of a Miniaturized Test Loop for the Assessment of Human Blood Damage by Continuous-Flow Left-Ventricular Assist Devices.

Eva Woelke, Ilona Mager, Thomas Schmitz-Rode, Ulrich Steinseifer, Johanna C Clauser

Abstract readValidation Study
In one paragraph

Article in Annals of biomedical engineering, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Standardization of In-Vitro Evaluation of Extracorporeal Life Support (ECLS) Devices for Research and Development.ASAIO journal (American Society for Artificial Internal Organs : 1992) · 2026
    Guideline
  2. Standardization ofPerfusion · 2026
    Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Frontiers in pediatrics · 2025
    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.

Eva WoelkeDepartment of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, Medical Faculty, RWTH Aachen University, Pauwelsstr. 20, 52074, Aachen, Germany.
Ilona MagerDepartment of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, Medical Faculty, RWTH Aachen University, Pauwelsstr. 20, 52074, Aachen, Germany.
Thomas Schmitz-RodeDepartment of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, Medical Faculty, RWTH Aachen University, Pauwelsstr. 20, 52074, Aachen, Germany.
Ulrich SteinseiferDepartment of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, Medical Faculty, RWTH Aachen University, Pauwelsstr. 20, 52074, Aachen, Germany.
Johanna C ClauserDepartment of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, Medical Faculty, RWTH Aachen University, Pauwelsstr. 20, 52074, Aachen, Germany. clauser@ame.rwth-aachen.de.ORCID http://orcid.org/0000-0002-9050-2391

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite improved hemocompatibility of left-ventricular assist devices (LVADs), assessment of blood damage remains mandatory in preclinical testing as standardized by ASTM-F1841. The most relevant test fluid is fresh, non-pooled human blood, but the limited volume of a standard donation requires significantly smaller loops than those commonly used with animal blood. In a recent study with porcine blood, we verified a miniaturized test loop with only 160 mL for the ASTM-conform paired testing of at least two LVADs and a static reference. Here, we validated this mini test loop for standardized assessment of blood damage with one 450-mL single donation of fresh human blood. Blood damage was assessed for HeartMate 3 and BPX-80 in 9 experiments with heparinized human blood for 6 hours. We analyzed plasma free hemoglobin, von Willebrand factor (vWF) concentration and collagen-binding functionality and calculated indices of hemolysis and vWF-ratios. Overall, we observed less blood damage compared to our previous study; however, the differences in mean indices of hemolysis and in mean normalized vWF-ratio between BPX-80 and HeartMate 3 were consistent for human blood. Thus, our mini test loop proved to be valid for preclinical standardized assessment of blood damage with only 450 mL of fresh human blood.

Indexed as

HemolysisAnimalsHeart-Assist DevicesHumansMaterials TestingMiniaturizationSwineHeartmate 3HemocompatibilityHemolysisIn vitro testingLVADvon Willebrand factor

Identifiers

PMID34431015
PMCPMC8671281

What OpenQuestion holds

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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.