Blood Donation With Hemapheresis
Conditions
Keywords
hemovigilance, hemapheresis, donor vigilance, plasmapheresis, platelet apheresis, leukapheresis, stem cell apheresis, granulocyte apheresis, monocyte apheresis, red cell apheresis
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.
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.
Interventions
OTHERblood donation
blood donation with preparative hemapheresis
Sponsors
Aix Scientifics
DGTI - Haemapheresis Vigilance Working Party
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* blood donor standard criteria : * healthy donor of \> 50 kg * hemoglobin 125 g/L or 7.8 mmol/L (female donors) * hemoglobin 135 g/L or 8.4 mmol/L (male donors) * hemoglobin \> 140 g/L for 2 unit red cell apheresis * total proteins \>= 60 g/L for plasmapheresis * platelet count \>= 150 × 10e9/L for platelet apheresis * blood volume of \> 5 L for 2 unit red cell apheresis * normal leukocyte count
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed