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Epistaxis clinical trials

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NCT ID: NCT00390663 Recruiting - Epistaxis Clinical Trials

A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children

Start date: October 2006
Phase: Phase 4
Study type: Interventional

To determine whether the selective application of a combined treatment regimen of silver nitrate cautery and 4 weeks of Naseptin cream is superior to naseptin treatment alone in the management of recurrent paediatric epistaxis.

NCT ID: NCT00355108 Completed - Clinical trials for Telangiectasia, Hereditary Hemorrhagic

ATERO : A Randomised Study With Tranexamic Acid in Epistaxis of Rendu Osler Syndrome

Start date: September 2006
Phase: Phase 3
Study type: Interventional

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.