Status:
COMPLETED
ATERO : A Randomised Study With Tranexamic Acid in Epistaxis of Rendu Osler Syndrome
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Telangiectasia, Hereditary Hemorrhagic
Osler-Rendu Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Argumentation Rendu-Osler syndrome, rare but ubiquitary, affects at least 8000 persons in France. This genetic disorder is characterised by a dominant autosomal hereditary transmission of telangiectas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00355108
Start Date
September 1 2006
End Date
May 1 2010
Last Update
May 28 2019
Active Locations (1)
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1
Henri PLAUCHU
Lyon, France, 69002