NCT06060639

Brief 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 most impacted by red blood cell transfusion ? Participants will have a transthoracic echocardiography before, just after and 15 minutes after red blood cell transfusion.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Nov 2023May 2027

First Submitted

Initial submission to the registry

September 25, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 9, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

3.6 years

First QC Date

September 25, 2023

Last Update Submit

December 22, 2025

Conditions

AnemiaAge ProblemUltrasonography

Outcome Measures

Primary Outcomes (1)

  • E/A ratio modification

    E/A ratio permits to estimate left ventricle pressure

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

Secondary Outcomes (5)

  • E/e' ratio modification

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

  • E wave deceleration time

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

  • Velocity-time Integral (VTI) modification

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

  • Lung score modification

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

  • New York Heart Association scale (NYHA) modification

    baseline and 24 hour after red blood cells transfusion

Study Arms (1)

transfused patients

EXPERIMENTAL

patients receiving red blood cell transfusion

Diagnostic Test: transthoracic echocardiography

Interventions

transthoracic echocardiographyDIAGNOSTIC_TEST

E wave, A wave, e' and vdi measurement

transfused patients

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, Gard, 30900, France

RECRUITING

Related Publications (10)

  • 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: 27846276BACKGROUND

  • 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: 35316810BACKGROUND

  • 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: 34932836BACKGROUND

  • 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: 34199655BACKGROUND

  • 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: 33880771BACKGROUND

  • 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: 30570487BACKGROUND

  • 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: 30488959BACKGROUND

  • 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: 30605034BACKGROUND

  • 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.

    PMID: 35560234BACKGROUND

  • 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.

    PMID: 28402044BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2023

First Posted

September 29, 2023

Study Start

November 9, 2023

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations

FR(1)