An observational study in Blood Donation With Hemapheresis, sponsored by DGTI - Haemapheresis Vigilance Working Party. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by DGTI - Haemapheresis Vigilance Working Party · Observational
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.
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.
This is the only study on the registry with DGTI - Haemapheresis Vigilance Working Party as lead sponsor.
Counted across the registry records on this site, refreshed daily.
all blood donors having an Adverse Event during preparative cell aphereses
Inclusion Criteria:
healthy blood donors for blood cell aphereses
Other: blood donation
blood donation with preparative hemapheresis
Assessment of all non-trivial adverse events (AE) occurring during hemapheresis
All non-trivial AEs will be recorded regardless of whether anticipated products have been collected or not
Time frame: up to one year
Rate of products per apheresis
amount of obtained products vs. anticipated products
Time frame: hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses
No study locations are listed for this record.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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