Global assays for haemophilia

Completed

• 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

• Registration Number: ISRCTN95296852
• Lead Sponsor: Oxford University Hospitals NHS Trust

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29468639

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-23
• Study Completion: 2016-03-31
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.