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Assay to assess bleeding risk in haemophilia A and B patients: a case study

A coagulation laboratory in Cambridge is part of a pan-European study looking at the in vitro diagnostics potential for automated thrombin generation testing in the routine laboratory setting.

One of the leading haemophilia centres in the UK is taking part in a pan-European clinical study, initiated by Diagnostica Stago, to assess a new clinical role for thrombin generation testing. The aim is to identify which patients with severe haemophilia A and B are more at risk of bleeding.

Alongside centres of excellence in Italy and Spain, the specialist coagulation laboratory at Addenbrooke’s Hospital, part of Cambridge Hospitals NHS Foundation Trust, is investigating the clinical accuracy of Stago’s assay, the STG-BleedScreen. It will also confirm the performance of the company’s new fully automated thrombin generation system, the ST Genesia, in a clinical setting.

The primary objective of the Stago study is to show that thrombin generation (TG) is significantly decreased in patients with severe haemophilia A and B compared to healthy individuals. The study also aims to demonstrate how TG can help to assess the bleeding risk in haemophilia patients.

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