Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-02-06 @ 4:13 AM
Study NCT ID:
NCT02287012
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2014-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection -The European Perspective
Sponsor:
Pr Mohamad MOHTY
Organization:
Study Overview
Official Title:
Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection - The European Perspective
Status:
COMPLETED
Status Verified Date:
2016-01
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:
None
Brief Summary:
This study aims to observe the effects of the availability of plerixafor on the time and effort associated with autologous peripheral blood stem cell collection.
Detailed Description:
This non interventional study will consist of two parts:
I. Retrospective study:
A medical record review will be conducted covering 200 patients file undergoing peripheral blood stem cell mobilization in some European centers.
II. Prospective study :Time/Motion evaluation of actual apheresis - 20 events each center The actual apheresis events will be measured in consecutive patients scheduled to be candidates for peripheral blood stem mobilization in the apheresis area of the hospital. Each apheresis will be considered as one event . Should the patient receive more than 1 apheresis, each apheresis will be considered as one different event.
I. Retrospective study:
A medical record review will be conducted covering 200 patients file undergoing peripheral blood stem cell mobilization in some European centers.
II. Prospective study :Time/Motion evaluation of actual apheresis - 20 events each center The actual apheresis events will be measured in consecutive patients scheduled to be candidates for peripheral blood stem mobilization in the apheresis area of the hospital. Each apheresis will be considered as one event . Should the patient receive more than 1 apheresis, each apheresis will be considered as one different event.
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?: