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AnemiaTrans-USNCT06060639

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

A study testing transthoracic echocardiography in people with Anemia and Age Problem, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Anemia, Age Problem, Ultrasonography
What is being tested?
transthoracic echocardiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteFrance
Study dates
9 Nov 2023to 30 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting

  • CHU de Nîmes

    Nîmes, Gard, 30900

    fabien coisy, MD, +33612194369, fabien.coisy@gmail.com

    Laura Grau-Mercier, MD

    Recruiting

Other trials in France

About this study

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.
Being tested
transthoracic echocardiography
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transthoracic echocardiographyDiagnostic test

    E wave, A wave, e' and vdi measurement

Study groups in NCT06060639
Study groupRoleWhat they receive
transfused patientsExperimentalpatients receiving red blood cell transfusion
Receives: Diagnostic Test: transthoracic echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. E/A ratio modification

    E/A ratio permits to estimate left ventricle pressure

    Measured: Base line, just after and 15 minutes after red blood cell transfusion

Secondary outcomes (5)

  1. E/e' ratio modification

    E/e' assesses left ventricle diastolic function

    Measured: Base line, just after and 15 minutes after red blood cell transfusion

  2. E wave deceleration time

    E wave deceleration time is a reflect of left atrium pressures

    Measured: Base line, just after and 15 minutes after red blood cell transfusion

  3. Velocity-time Integral (VTI) modification

    Aortic velocity-time integral is the reflect of cardiac output

    Measured: Base line, just after and 15 minutes after red blood cell transfusion

  4. Lung score modification

    Lung score permits to asses if extravascular water is present in lungs

    Measured: Base line, just after and 15 minutes after red blood cell transfusion

  5. New York Heart Association scale (NYHA) modification

    NYHA is a validated scale to asses patient dyspnea

    Measured: baseline and 24 hour after red blood cells transfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2023
  2. Study start9 Nov 2023
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06060639
Sponsor's protocol ID
2023-A01236-39
Acronym
Trans-US
Status last verified
Dec 2025
First submitted
25 Sep 2023
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 30605034

  • Bosboom JJ, Klanderman RB, Terwindt LE, Bulle EB, Wijnberge M, Eberl S, Driessen AH, Winkelman TA, Geerts BF, Veelo DP, Hollmann MW, Vlaar APJ. Autologous red blood cell transfusion does not result in a more profound increase in pulmonary capillary wedge pressure compared to saline in critically ill patients: A randomized crossover trial. Vox Sang. 2022 Aug;117(8):1035-1042. doi: 10.1111/vox.13292. Epub 2022 May 13.

    PubMed 35560234

  • Dencker M, Stagmo M. Reported normal values and weighted means for commonly used echocardiography pulsed Doppler and tissue Doppler measurements. Clin Physiol Funct Imaging. 2018 May;38(3):341-350. doi: 10.1111/cpf.12427. Epub 2017 Apr 12.

    PubMed 28402044

Questions about this trial

What is this clinical trial studying?

A study testing transthoracic echocardiography in people with Anemia and Age Problem, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

E/A ratio modification (time frame: Base line, just after and 15 minutes after red blood cell transfusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06060639, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.

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