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Recruiting NCT06060639

Variation of Echocardiographic Parameters After Red Blood Cell Transfusion in Emergency Department Anemic Patients

No phase Interventional Anemia Age Problem Ultrasonography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transthoracic echocardiography.
Who it may be relevant to
Registry conditions: Anemia, Age Problem, Ultrasonography. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The goal of this interventional study is to asses echocardiographic variations in emergency department's elderly patients receiving red blood cell transfusion. The main questions it aims to answer are : * is there a modification of echocardiographic parameters after red blood cell transfusion ? * which parameter is the most impacted by red blood cell transfusion ? Participants will have a transthoracic echocardiography before, just after and 15 minutes after red blood cell transfusion.

Interventions

  • Diagnostic test transthoracic echocardiography
    E wave, A wave, e' and vdi measurement

Primary outcome measures

  • E/A ratio modification [Time frame: Base line, just after and 15 minutes after red blood cell transfusion]
Secondary outcome measures (5)
  • E/e' ratio modification [Time frame: Base line, just after and 15 minutes after red blood cell transfusion]
  • E wave deceleration time [Time frame: Base line, just after and 15 minutes after red blood cell transfusion]
  • Velocity-time Integral (VTI) modification [Time frame: Base line, just after and 15 minutes after red blood cell transfusion]
  • Lung score modification [Time frame: Base line, just after and 15 minutes after red blood cell transfusion]
  • New York Heart Association scale (NYHA) modification [Time frame: baseline and 24 hour after red blood cells transfusion]

Eligibility criteria

Inclusion criteria

  • patient needing red blood cell transfusion
  • consent
  • social protection

Exclusion criteria

  • fluid filing over 500 mL of crystalloids
  • transfusion in the last hour

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHU de Nîmes — Nîmes

Publications

  • Le CH. The Prevalence of Anemia and Moderate-Severe Anemia in the US Population (NHANES 2003-2012). PLoS One. 2016 Nov 15;11(11):e0166635. doi: 10.1371/journal.pone.0166635. eCollection 2016. PMID 27846276
  • Weiss A, Beloosesky Y, Gingold-Belfer R, Leibovici-Weissman Y, Levy Y, Mulla F, Issa N, Boltin D, Koren-Morag N, Meyerovitch J, Sharon E, Schmilovitz-Weiss H. Association of Anemia with Dementia and Cognitive Decline among Community-Dwelling Elderly. Gerontology. 2022;68(12):1375-1383. doi: 10.1159/000522500. Epub 2022 Mar 22. PMID 35316810
  • Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5. PMID 34932836
  • Peyrony O, Gamelon D, Brune R, Chauvin A, Ghazali DA, Yordanov Y, Arsicaud A, Gilleron P, Curac S, Richard MC, Feral-Pierssens AL, Villoing B, Beaune S, Goulet H, Fontaine JP, Francois A, Pirenne F. Red Blood Cell Transfusion in the Emergency Department: An Observational Cross-Sectional Multicenter Study. J Clin Med. 2021 Jun 2;10(11):2475. doi: 10.3390/jcm10112475. PMID 34199655
  • Kracalik I, Mowla S, Basavaraju SV, Sapiano MRP. Transfusion-related adverse reactions: Data from the National Healthcare Safety Network Hemovigilance Module - United States, 2013-2018. Transfusion. 2021 May;61(5):1424-1434. doi: 10.1111/trf.16362. Epub 2021 Apr 20. PMID 33880771
  • Roubinian N. TACO and TRALI: biology, risk factors, and prevention strategies. Hematology Am Soc Hematol Educ Program. 2018 Nov 30;2018(1):585-594. doi: 10.1182/asheducation-2018.1.585. Epub 2018 Dec 14. PMID 30570487
  • Klanderman RB, Bosboom JJ, Migdady Y, Veelo DP, Geerts BF, Murphy MF, Vlaar APJ. Transfusion-associated circulatory overload-a systematic review of diagnostic biomarkers. Transfusion. 2019 Feb;59(2):795-805. doi: 10.1111/trf.15068. Epub 2018 Nov 29. PMID 30488959
  • Morita T, Nakamura K, Osuga T, Yokoyama N, Morishita K, Sasaki N, Ohta H, Takiguchi M. Effect of acute volume overload on echocardiographic indices of right ventricular function and dyssynchrony assessed by use of speckle tracking echocardiography in healthy dogs. Am J Vet Res. 2019 Jan;80(1):51-60. doi: 10.2460/ajvr.80.1.51. PMID 30605034

Identifiers

NCT: NCT06060639 · 2023-A01236-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗