- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409967
The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias (BÉA/T)
Study Overview
Status
Conditions
Detailed Description
The aim of this work is to study the changes of key assays useful for the understanding of anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays, hemolysis markers.
The patient selection criteria are:
- age > or = 18 years
- No history of transfusion > or = 2 years
- Anemia (any etiology known or assumed)
- Decision of red packed cells transfusion for the current episode
- Transfusion performed at BEAUJON Hospital
- Agreement of patient for the study
Number of subjects required: 100 patients
Study duration and duration of participation for each patient:
- duration of the study: 1 year
- for each patient the participation to the study began at baseline after the decision of transfusion and stopped at the second sample ie at least 72 hours after the transfusion of red blood cells.
The maximum contribution for one patient is 5 days.
Methodology: It is a prospective non interventional monocentric (BEAUJON Hospital) study. Two blood tests will be performed; one before transfusion and the other from 48 to 72 hours after red packed cells transfusion.
The following parameters will be measured before and after red packed cells transfusion:
Complete blood count (CBC) with reticulocyte count; complete iron status (ferritin, serum iron, transferrin, transferrin saturation), soluble transferrin receptor; serum and intraerythrocytic folate levels, vitamin B12; lactate dehydrogenase (LDH), bilirubin (total and free), haptoglobin, orosomucoid, direct coombs test; creatinine; CRP.
The aim of this work is to study the changes of key assays useful for the understanding of anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays, hemolysis markers.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Clichy, France, 92110
- Hopital Beaujon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
INCLUSION CRITERIA:
- Age > or = 18 years
- No history of transfusion > or = 2 years
- Anemia (any etiology known or assumed)
- Decision of red packed cells transfusion for the current episode
- Transfusion performed at BEAUJON Hospital
- Agreement of patient for the study
EXCLUSION CRITERIA:
- Patient who received between the 2 samples, a treatment which can modify the parameters evaluated (iron, vitamin)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
anemia
Time Frame: 72 hours
|
72 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Froissart Antoine, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI 10060
- HAO 10048 (Other Identifier: Management number)
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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