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The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias (BÉA/T)

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ClinicalTrials.gov Identifier: NCT01409967
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : August 26, 2013
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease
Anemia

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 : Observational
Actual Enrollment : 40 participants
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
Study Start Date : May 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. anemia [ Time Frame: 72 hours ]

Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Anemic patient with decision of red packed cells transfusion for the current episode.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409967


Locations
France
Hopital BEAUJON
Clichy, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Froissart Antoine Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01409967     History of Changes
Other Study ID Numbers: NI 10060
HAO 10048 ( Other Identifier: Management number )
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Anemia
Transfusion
Biological markers

Additional relevant MeSH terms:
Anemia
Hematologic Diseases