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
  Purpose

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
Anemia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • anemia [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 40
Study Start Date: May 2011
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01409967     History of Changes
Other Study ID Numbers: NI 10060, HAO 10048
Study First Received: August 3, 2011
Last Updated: August 23, 2013
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014