The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias

NCT ID: NCT01409967

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Anemia

Keywords

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Anemia Transfusion Biological markers

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Froissart Antoine

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital BEAUJON

Clichy, , France

Site Status

Countries

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France

Other Identifiers

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HAO 10048

Identifier Type: OTHER

Identifier Source: secondary_id

NI 10060

Identifier Type: -

Identifier Source: org_study_id