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Variation of Echocardiographic Parameters After Red Blood Cell Transfusion in Emergency Department Anemic Patients (Trans-US)

Primary Purpose

Anemia, Age Problem, Ultrasonography

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transthoracic echocardiography
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anemia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nîmes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transfused patients

Arm Description

patients receiving red blood cell transfusion

Outcomes

Primary Outcome Measures

E/A ratio modification
E/A ratio permits to estimate left ventricle pressure

Secondary Outcome Measures

E/e' ratio modification
E/e' assesses left ventricle diastolic function
E wave deceleration time
E wave deceleration time is a reflect of left atrium pressures
VTI modification
Aortic velocity time integral is the reflect of cardiac output
Lung score modification
Lung score permits to asses if extravascular water is present in lungs
NYHA modification
NYHA is a validated scale to asses patient dyspnea

Full Information

First Posted
September 25, 2023
Last Updated
September 25, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT06060639
Brief Title
Variation of Echocardiographic Parameters After Red Blood Cell Transfusion in Emergency Department Anemic Patients
Acronym
Trans-US
Official Title
Variation of Echocardiographic Parameters After Red Blood Cell Transfusion in Emergency Department Anemic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Age Problem, Ultrasonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transfused patients
Arm Type
Experimental
Arm Description
patients receiving red blood cell transfusion
Intervention Type
Diagnostic Test
Intervention Name(s)
transthoracic echocardiography
Intervention Description
E wave, A wave, e' and vdi measurement
Primary Outcome Measure Information:
Title
E/A ratio modification
Description
E/A ratio permits to estimate left ventricle pressure
Time Frame
Base line, just after and 15 minutes after red blood cell transfusion
Secondary Outcome Measure Information:
Title
E/e' ratio modification
Description
E/e' assesses left ventricle diastolic function
Time Frame
Base line, just after and 15 minutes after red blood cell transfusion
Title
E wave deceleration time
Description
E wave deceleration time is a reflect of left atrium pressures
Time Frame
Base line, just after and 15 minutes after red blood cell transfusion
Title
VTI modification
Description
Aortic velocity time integral is the reflect of cardiac output
Time Frame
Base line, just after and 15 minutes after red blood cell transfusion
Title
Lung score modification
Description
Lung score permits to asses if extravascular water is present in lungs
Time Frame
Base line, just after and 15 minutes after red blood cell transfusion
Title
NYHA modification
Description
NYHA is a validated scale to asses patient dyspnea
Time Frame
baseline and 24 hour after red blood celle transfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU de Nîmes
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30900
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
fabien coisy, MD
Phone
+33612194369
Email
fabien.coisy@gmail.com
First Name & Middle Initial & Last Name & Degree
Laura Grau-Mercier, MD
First Name & Middle Initial & Last Name & Degree
Fabien Coisy, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27846276
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.
Results Reference
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PubMed Identifier
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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.
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PubMed Identifier
34932836
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.
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PubMed Identifier
34199655
Citation
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Results Reference
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PubMed Identifier
33880771
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.
Results Reference
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PubMed Identifier
30570487
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.
Results Reference
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PubMed Identifier
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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.
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PubMed Identifier
30605034
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.
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PubMed Identifier
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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.
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Variation of Echocardiographic Parameters After Red Blood Cell Transfusion in Emergency Department Anemic Patients

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