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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06060639
Collaborator
(none)
116
Enrollment
1
Location
1
Arm
7
Anticipated Duration (Months)
16.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: transthoracic echocardiography
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
116 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Variation of Echocardiographic Parameters After Red Blood Cell Transfusion in Emergency Department Anemic Patients
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: transfused patients

patients receiving red blood cell transfusion

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

Outcome Measures

Primary Outcome Measures

  1. E/A ratio modification [Base line, just after and 15 minutes after red blood cell transfusion]

    E/A ratio permits to estimate left ventricle pressure

Secondary Outcome Measures

  1. E/e' ratio modification [Base line, just after and 15 minutes after red blood cell transfusion]

    E/e' assesses left ventricle diastolic function

  2. E wave deceleration time [Base line, just after and 15 minutes after red blood cell transfusion]

    E wave deceleration time is a reflect of left atrium pressures

  3. VTI modification [Base line, just after and 15 minutes after red blood cell transfusion]

    Aortic velocity time integral is the reflect of cardiac output

  4. Lung score modification [Base line, just after and 15 minutes after red blood cell transfusion]

    Lung score permits to asses if extravascular water is present in lungs

  5. NYHA modification [baseline and 24 hour after red blood celle transfusion]

    NYHA is a validated scale to asses patient dyspnea

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nîmes Nîmes Gard France 30900

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT06060639
Other Study ID Numbers:
  • 2023-A01236-39
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Emergencies

Study Results

No Results Posted as of Sep 29, 2023