Multinational Haemapheresis Vigilance Study
This trial is active, not recruiting.
|Condition||blood donation with hemapheresis|
|Sponsor||DGTI - Haemapheresis Vigilance Working Party|
|Start date||February 2012|
|End date||February 2017|
|Trial size||50000 participants|
|Trial identifier||NCT01576237, DGTI-AGHV_01|
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.
healthy blood donors for blood cell aphereses
Assessment of all non-trivial adverse events (AE) occurring during hemapheresis
time frame: up to one year
Rate of products per apheresis
time frame: hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses
Male or female participants from 18 years up to 65 years old.
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
|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|
|Principal investigator||Hans-Gert Heuft, PD. Dr. med.|
|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.|
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