- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06060639
Variation of Echocardiographic Parameters After Red Blood Cell Transfusion in Emergency Department Anemic Patients (Trans-US)
December 22, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gard
-
Nîmes, Gard, France, 30900
- Recruiting
- CHU de Nîmes
-
Contact:
- fabien coisy, MD
- Phone Number: +33612194369
- Email: fabien.coisy@gmail.com
-
Sub-Investigator:
- Laura Grau-Mercier, MD
-
Principal Investigator:
- Fabien COISY, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: transfused patients
patients receiving red blood cell transfusion
|
E wave, A wave, e' and vdi measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
E/A ratio modification
Time Frame: Base line, just after and 15 minutes after red blood cell transfusion
|
E/A ratio permits to estimate left ventricle pressure
|
Base line, just after and 15 minutes after red blood cell transfusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
E/e' ratio modification
Time Frame: Base line, just after and 15 minutes after red blood cell transfusion
|
E/e' assesses left ventricle diastolic function
|
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
|
E wave deceleration time is a reflect of left atrium pressures
|
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
|
Lung score permits to asses if extravascular water is present in lungs
|
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
|
Aortic velocity-time integral is the reflect of cardiac output
|
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
|
NYHA is a validated scale to asses patient dyspnea
|
baseline and 24 hour after red blood cells transfusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Pelton WJ, McNeal DR, Goggans JK. Student dental health program of the University of Alabama in Birmingham. IV. Enrollment and utilization. Ala J Med Sci. 1971 Jul;8(3):283-7. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 9, 2023
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2027
Study Registration Dates
First Submitted
September 25, 2023
First Submitted That Met QC Criteria
September 25, 2023
First Posted (Actual)
September 29, 2023
Study Record Updates
Last Update Posted (Actual)
December 30, 2025
Last Update Submitted That Met QC Criteria
December 22, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-A01236-39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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