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Completed

NCT Number: NCT01409967

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital BEAUJON

Clichy, 92110, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. anemia

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: BÉA/T

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 4, 2011
Registry last updated
Aug 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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