Global assays for haemophilia
Research type
Research Study
Full title
Global haemostasis assays: their use in patients with haemophilia
IRAS ID
185078
Contact name
Nicola Curry
Contact email
Sponsor organisation
Oxford University Hospitals NHS Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The current tests for haemophilia look at clotting factors VIII and IX. The study is designed to assess whether two laboratory tests (called Rotational thromboelastometry (ROTEM) and thrombin generation test (TGT)) can be used to assess the effects of treatment and bleeding risk in patients with haemophilia.
Haemophilia A and haemophilia B are hereditary disorders primarily affecting males, characterised by a deficiency in clotting factors. Haemophilia confers an increased risk of bleeding (in particular joint and muscle bleeds) and the severity of the disease is defined according to the amount of clotting factor (VIII or IX) found in the blood.
The currently used tests look at clotting factors (factor VIII in haemophilia A or factor IX levels in haemophilia B) in the blood and are commonly used in patients who receive regular infusions of replacement factor concentrate. Routine testing involves analysing a trough blood sample (taken before treatment) and this is used currently to help adjust the concentration of factor administered to the patient, if necessary.
However, it is known that patients with similar levels of clotting factor in their blood (or indeed with the same trough blood levels) have different risks of bleeding. The standard clotting tests used in the laboratory do not pick up these differences in bleeding risks, but these two new tests look at the overall ability of the blood to clot, which include clotting factors that are pro-clotting as well as factors that are anti-clotting. These tests may be better at predicting overall response to therapy as well as overall bleeding risks in patients with haemophilia.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
15/EM/0477
Date of REC Opinion
16 Oct 2015
REC opinion
Favourable Opinion