Multinational Haemapheresis Vigilance Study
During a five 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.
|Study Design:||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|
- Assessment of all non-trivial adverse events (AE) occurring during hemapheresis [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]All non-trivial AEs will be recorded regardless of whether anticipated products have been collected or not
- Rate of products per apheresis [ Time Frame: hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses ] [ Designated as safety issue: No ]amount of obtained products vs. anticipated products
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
healthy apheresis donors
healthy blood donors for blood cell aphereses
Other: blood donation
blood donation with preparative hemapheresis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576237
|Principal Investigator:||Hans-Gert Heuft, PD. Dr. med.||Hannover Medical School (MHH)|