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Global assays for haemophilia

Global haemostasis assays: their use in patients with haemophilia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN95296852
Enrollment
50
Registered
2015-07-23
Start date
2015-10-01
Completion date
Unknown
Last updated
2018-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study is evaluating newer global blood clotting tests and their use and reproducibility in patients with haemophilia A and haemophilia B. Haematological Disorders Haemophilia

Interventions

Participants will be asked to provide one or two additional aliquots of blood (5.4 ml citrated blood) for this study whilst undergoing routine clinical assessment. No additional blood draws will be re
a ‘baseline’ blood sample is taken for testing either factor VIII or factor IX levels. Patients who require prophylactic treatment (regular infusions) routinely have two blood samples taken in clini

Sponsors

Oxford University Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male, aged 18 years or above 3. Diagnosed with haemophilia A or B

Exclusion criteria

Exclusion criteria: Concomitant use of pro-haemostatic agents such as tranexamic acid or anti-coagulant agent

Design outcomes

Primary

MeasureTime frame
The primary outcome is to find a normal range for thrombin generation and ROTEM measures in patients with haemophilia as measured by evaluating a blood sample at time 0 hours. The blood will be tested for thrombin generation and for whole blood viscoelastometric measures which are both global measures of coagulation.

Secondary

MeasureTime frame
Secondary outcome will be to correlate the laboratory tests with clinical outcome. Thrombin generation measures and ROTEM measures will be compared at time 0 hours and correlated with the number of joint bleeds that a patient has as measured using an annualised bleeding rate.

Countries

United Kingdom

Contacts

Public ContactNicola Curry
nicola.curry@ouh.nhs.uk01865 225316

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026