| Aix Scientifics® Clinical Research Organisation |
Apheresis VigilanceA new Haemapheresis Vigilance System of the Section 'Preparative and Therapeutic Haemapheresis' of the German Society for Transfusion Medicine and Immunohaematology (DGTI e.V.) is under construction. It is developed by the Haemapheresis Vigilance Working Party (AGHV) of the Section in cooperation with Aix Scientifics®. Since February 2012 the pilot phase (beta version) is running. After completion of the pilot phase all members of the DGTI as well as all other transfusion medicine establishments in Germany, Austria and Switzerland are invited to participate. In the scope of a five-years study non-trivial Adverse Events related to preparative haemaphereses will be registered. [ see ClinicalTrials.gov : NCT01576237 ] 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 multi-component aphereses. The haemapheresis centres can automatically evaluate their data according to the advanced standards of the International Haemovigilance Network (IHN) and can compare their own results to the results of the total of all other participating centres. The members of the Haemapheresis Vigilance Working Party (AGHV) are : |