Hereditary Hemorrhagic Telangiectasia
Conditions
Keywords
Hereditary hemorrhagic telangiectasia, Rendu-Osler-Weber syndrome, Epistaxis, Nosebleeds, Anemia, Tranexamic acid, Antifibrinolytics
Brief summary
Hereditary hemorrhagic telangiectasia (HHT, Rendu-Osler-Weber Syndrome) is associated with frequent nosebleeds in the majority of cases. Several reports in the literature support the use of antifibrinolytics like Tranexamic acid to reduce nosebleeds. The objectives of the study are to test if Tranexamic acid taken orally can 1. improve anemia (lead to an increased hemoglobin level) 2. reduce nosebleeds.
Interventions
DRUGTranexamic acid first, than placebo
For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.
DRUGFirst placebo, than Tranexamic acid.
First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.
Sponsors
Pharmacia GmbH, Erlangen, Germany
Baxter Healthcare Corporation
University Hospital, Saarland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* hereditary hemorrhagic telangiectasia with nosebleeds and desire to be treated.
Exclusion criteria
* pregnant, * minor, * had an increased risk of thrombotic events (history or signs of cerebrovascular events, cardiac arrhythmias, biochemically increased coagulation parameters), * renal insufficiency, * a history of massive hematuria or defects of color vision.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of hemoglobin level within the phases. | Beginning and end of each 3 months period. |
Secondary
| Measure | Time frame |
|---|---|
| Mean epistaxis score (daily duration multiplied by mean subjective daily intensity) | Measured once a day during each 3 months period |
Countries
Germany
Outcome results
None listed