Multinational Haemapheresis Vigilance Study

Sponsor

DGTI - Haemapheresis Vigilance Working Party (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01576237

Collaborator

Aix Scientifics (Industry)

50,000

Enrollment

130

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

During a seven years period the participating transfusion medicine establishments will report all their non-trivial adverse events (AE) occurring during preparative hemaphereses. Complications may be related to the blood donors, the blood products, the disposables or the apheresis devices. The study hypothesis regarding each participating center is that their procedure-related AE rate is not higher than the respective rate of all other centers in total.

Condition or Disease	Intervention/Treatment	Phase
Blood Donation With Hemapheresis	Other: blood donation

Detailed Description

In the scope of this study the participating transfusion medicine establishments obligate themselves to record all significant Adverse Events (AE) related to preparative hemaphereses of healthy donors. All complications (phlebotomy and circulation problems, citrate toxicity, donor compliance, and technical complications) shall be assessed with respect to plasma-, platelet-, leukocyte- (stem cells, granulocytes, monocytes), and red cell aphereses as well as multicomponent aphereses. Study data are recorded by means of an Internet-based hemapheresis vigilance system. Study results will be evaluated according to the advanced standards of the International Haemovigilance Network (IHN). The study contributes to the quality assurance of each single center as it enables the comparison to other transfusion medicine establishments.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Open Prospective Multi-national Long-term Study to Register Adverse Events Related to Hemaphereses by Means of an Internet-based Haemapheresis Vigilance Questionnaire

Actual Study Start Date :

Feb 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
healthy apheresis donors healthy blood donors for blood cell aphereses	Other: blood donation blood donation with preparative hemapheresis

Arm

Intervention/Treatment

healthy apheresis donors

healthy blood donors for blood cell aphereses

Other: blood donation

blood donation with preparative hemapheresis

Outcome Measures

Primary Outcome Measures

Assessment of all non-trivial adverse events (AE) occurring during hemapheresis [up to one year]
All non-trivial AEs will be recorded regardless of whether anticipated products have been collected or not

Secondary Outcome Measures

Rate of products per apheresis [hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses]
amount of obtained products vs. anticipated products