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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01409967
First received: August 3, 2011
Last updated: August 23, 2013
Last verified: August 2013

August 3, 2011
August 23, 2013
May 2011
May 2013   (final data collection date for primary outcome measure)
anemia [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01409967 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias
The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias

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 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.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood

Probability Sample

Anemic patient with decision of red packed cells transfusion for the current episode.

Anemia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2013
May 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01409967
NI 10060, HAO 10048
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Froissart Antoine Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP