The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias (BÉA/T)
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Purpose
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.
| Condition |
|---|
|
Anemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Prospective |
| Official Title: | The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias |
- anemia [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Anemic patient with decision of red packed cells transfusion for the current episode.
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)
Contacts and Locations| France | |
| Hopital BEAUJON | Recruiting |
| Clichy, France, 92110 | |
| Contact: FROISSART ANTOINE 1 40 87 52 27 ext + 33 antoine.froissart@bjn.aphp.fr | |
| Principal Investigator: | Froissart Antoine | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01409967 History of Changes |
| Other Study ID Numbers: | NI 10060, HAO 10048 |
| Study First Received: | August 3, 2011 |
| Last Updated: | January 23, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Anemia Transfusion Biological markers |
Additional relevant MeSH terms:
|
Anemia Hematologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013