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

Anemia Clinical Trial

— BÉA/T  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409967
• Other study ID #: NI 10060
• Secondary ID: HAO 10048
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: August 23, 2013
• Start date: May 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
France	Hopital BEAUJON	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anemia		72 hours	No