ATERO : A Randomised Study With Tranexamic Acid in Epistaxis of Rendu Osler Syndrome
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
Scientific Objectives Primary objective : Demonstrate that oral intake of tranexamic acid
significantly reduces the risk of epistaxis occurrence, estimated by the average monthly
duration of episodes of epistaxis.
Secondary objectives :
- Document the benefit of tranexamic acid on the amount of haemoglobine and quality of
life of patients.
- Identify scalable and genetic factors of response to the treatment by tranexamic acid.
- Describe compliance and tolerance of the treatment. Method Experimental Design We
suggest the realisation of a randomised comparative clinical trial versus placebo, with
a crossover of random alternated periods of three months over a total of six months.
Study Population 213 affected patients, displaying sufficiently invalidating epistaxis to
require a basal treatment, will be recruited and followed every 3 months. Recruitment will
lean on teams who are part of the national French network in close collaboration with the
reference centre for the Rendu-Osler disorder, appointed to Lyon on the 19th of November
2004. Follow up of the study will be carried out by the Clinical Investigational Centre of
the related towns.
Outcome measures The main criterion of efficacy is the average duration of epistaxis, the
secondary criterion of efficacy is the average number of epistaxis measured per month.
Tolerance will be analysed according to the occurrence of venal or arterial thrombosis and
allergic accidents. Venal thrombosis will systematically be sought by an inferior limbs
echodoppler. Response markers will be sought through modelisation incorporating
environmental, phenotypic and genetic factors.