ATERO : A Randomised Study With Tranexamic Acid in Epistaxis of Rendu Osler Syndrome
Telangiectasia, Hereditary Hemorrhagic, Osler-Rendu Disease
About this trial
This is an interventional treatment trial for Telangiectasia, Hereditary Hemorrhagic focused on measuring Rendu Osler syndrome, Epistaxis, Tranexamic acid, clinical trial
Eligibility Criteria
Inclusion Criteria: Repeated, spontaneous epistaxis in a known Rendu Osler patient who wants global caring, these must be daily epistaxis (> 28 a month) or a total amount of 60 minutes of bleeding a month (50 % Rendu-Osler patients bleed before 20 and 99 % at 50 when penetrance is complete). Good completion of the grid of control by recording the number and duration of epistaxis over a period of three month. Exclusion Criteria: Rendu Osler syndrome with specific phenotype : absence of epistaxis or occasional epistaxis, no need for particular care. Maintained expectations of an ENT treatment of epistaxis in a delay of three months. Incapacity of detailing the number of epistaxis, especially, at least, within three months before entering the study. No informed consent obtained after informing the patient on his participation to the study. Expected lack of observance because of an incapacity to compel to the daily treatment. Formal indication to Tranexamic Acid (angioneurotic oedema as a disease modifying treatment of 3 to 4 g/ day). Contra-indications to Tranexamic acid: history of convulsion, arterial or veinous thrombosis, , positivity of veinous echo doppler of the inferior limbs; Serum creatinine > 250 µmol/l. N.B. Cases of bad observance are not frequent, patients being highly concerned with a treatment to reduce their discomfort and anaemia. They are more likely ready to move to a centre insuring this handling. Nevertheless, lack of observance will be detected over a period of 15 days of placebo in simple blind, before randomization.
Sites / Locations
- Henri PLAUCHU