Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01409967
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2011-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BÉA/T
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HAO 10048 | OTHER | Management number | View |