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

Anemia Clinical Trial

— Trans-US  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060639
• Other study ID #: 2023-A01236-39
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: November 9, 2024

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: November 9, 2024
• Est. primary completion date: November 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Problem
• Anemia
• Emergencies
• Ultrasonography

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	E/e' ratio modification	E/e' assesses left ventricle diastolic function	Base line, just after and 15 minutes after red blood cell transfusion
Secondary	E wave deceleration time	E wave deceleration time is a reflect of left atrium pressures	Base line, just after and 15 minutes after red blood cell transfusion
Secondary	Velocity-time Integral (VTI) modification	Aortic velocity-time integral is the reflect of cardiac output	Base line, just after and 15 minutes after red blood cell transfusion
Secondary	Lung score modification	Lung score permits to asses if extravascular water is present in lungs	Base line, just after and 15 minutes after red blood cell transfusion
Secondary	New York Heart Association scale (NYHA) modification	NYHA is a validated scale to asses patient dyspnea	baseline and 24 hour after red blood cells transfusion