Details of the EUHASS data collection and reporting system
Surveillance began on 1 October 2008.
Patients included in the surveillance
von Willebrand’s disease: type 1 severe (<15% VWF:RiCo), type 2, type 3, type unknown
Factor I deficiency: Afibrinogenemia (<10mg/dl), Hypofibrinogenemia (10-50 mg/dl), Dysfibrinogenemia (50-150 mg/dl)
Factor II deficiency
Factor V deficiency
Factor VII deficiency
Factor X deficiency
Factor XI deficiency
Factor XIII deficiency
Alpha 2 antiplasmin deficiency
Combined Factor V+VIII deficiency
Combined Factor II, VII, IX, X deficiency
Acquired haemophilia A†
Platelet storage pool disease†
†Diagnoses added to surveillance from 1 July 2012
Patients excluded from surveillance
Patients with acquired clotting factor deficiencies, unless they are Acquired haemophilia or Acquired VWD.
Events to be reported during surveillance
Allergic or other acute event
Transfusion transmitted infections
Inhibitors (antibodies against the coagulation factor)
New cardiovascular events
New malignancy diagnoses
Unexpected Poor Efficacy*
Other Adverse Event Possibly Related to Concentrate*
*Reporting of these events was from pilot centres only 1 October 2010 – 30 June 2012, reporting expanded to all centres from 1 July 2012.
At the end of each complete year of surveillance participating centres provide data on the number of patients registered with them and the clotting factor concentrates used to treat them. Centres may report usage of unlicensed clinical trial products (no product name is reported) as well as licensed named products.
IT Development and Support by MDSAS