Clinical trial NCT06060639: Variation of Echocardiographic Parameters After Red Blood Cell Transfusion in Emergency Department Anemic Patients
Official title: Variation of Echocardiographic Parameters After Red Blood Cell Transfusion in Emergency Department Anemic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anemia
Age Problem
Ultrasonography
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 116
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: E/A ratio modification
timeFrame: Base line, just after and 15 minutes after red blood cell transfusion
Secondary outcomes:
measure: E/e' ratio modification
timeFrame: Base line, just after and 15 minutes after red blood cell transfusion
measure: E wave deceleration time
timeFrame: Base line, just after and 15 minutes after red blood cell transfusion
measure: Velocity-time Integral (VTI) modification
timeFrame: Base line, just after and 15 minutes after red blood cell transfusion
measure: Lung score modification
timeFrame: Base line, just after and 15 minutes after red blood cell transfusion
measure: New York Heart Association scale (NYHA) modification
timeFrame: baseline and 24 hour after red blood cells transfusion
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
state: Gard
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.
citation: 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.
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.