GlobALL
Research type
Research Study
Full title
Global tests of blood clotting during asparaginase treatment for acute lymphoblastic leukaemia.
IRAS ID
166572
Contact name
Charlotte Bradbury
Contact email
Sponsor organisation
Research and Innovation Development
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Asparaginase is an essential drug for treating acute lymphoblastic leukaemia (ALL), the most common leukaemia in the young. However, asparaginase also causes thrombosis in up to 37% of patients, which may be life-threatening. Most adults with ALL receive daily injections of the anticoagulant drug heparin to prevent thrombosis but this is not always effective. Heparin may also increase bleeding complications.
Blood tests are often done on ALL patients to assess the risk of thrombosis and of bleeding so that appropriate treatments can be given. However, ‘conventional’ laboratory tests of blood clotting are unsuitable for ALL patients, because asparaginase causes complex changes in blood clotting, some of which are undetectable using these tests. An alternative is to use 'global' tests, which give a broader picture of blood clotting that will reflect the overall effects of asparaginase. Global tests are already used to monitor blood clotting in other complex settings such as heart surgery and liver disease.
In this pilot study, we will test the feasibility and utility of global tests in ALL patients receiving asparaginase. We will test patient blood samples using both conventional and global tests, focussing on clotting tests that measure heparin. If we show that global tests give better information about blood clotting than conventional tests, we will use the study results to design a larger study of the clinical benefit of global tests. We expect that better monitoring of blood clotting in ALL patients will reduce thrombosis and bleeding and to improve patient outcomes.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/1315
Date of REC Opinion
22 Dec 2014
REC opinion
Further Information Favourable Opinion