Clinical trial NCT01409967: The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias
Official title: The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Keywords: Anemia
Transfusion
Biological markers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anemic patient with decision of red packed cells transfusion for the current episode.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: anemia
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hopital BEAUJON
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Froissart Antoine
role: PRINCIPAL_INVESTIGATOR
References: