Telangiectasia, Hereditary Hemorrhagic Clinical Trial
Official title:
ATERO : A Randomised Study With Tranexamic Acid in Epistaxis of Rendu Osler Syndrome. Beneficial or Iatrogenic Effects.
NCT number | NCT00355108 |
Other study ID # | 2005.405 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | September 2006 |
Est. completion date | May 2010 |
Verified date | December 2010 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Henri PLAUCHU | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Gaillard S, Dupuis-Girod S, Boutitie F, Rivière S, Morinière S, Hatron PY, Manfredi G, Kaminsky P, Capitaine AL, Roy P, Gueyffier F, Plauchu H; ATERO Study Group. Tranexamic acid for epistaxis in hereditary hemorrhagic telangiectasia patients: a European — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary efficacy criterion is the average monthly duration of epistaxis. | after first 3 month period treatment or placebo and after second 3 month period treatment or placebo | ||
Secondary | the average monthly number of epistaxis, | after first 3 month period treatment or placebo and after second 3 month period treatment or placebo | ||
Secondary | the average duration of one episode of epistaxis measured over a month, | after first 3 month period treatment or placebo and after second 3 month period treatment or placebo | ||
Secondary | the Haemoglobin level | after first 3 month period treatment or placebo and after second 3 month period treatment or placebo | ||
Secondary | estimation of Quality of life. | over first 3 month period treatment or placebo and over second 3 month period treatment or placebo | ||
Secondary | Outcome of following Adverse Event: arterial or veinous thrombosis, allergic accident | during first 3 month period treatment or placebo and over second 3 month period treatment or placebo |
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