Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) (TAHHT)

University Hospital, Saarland

Status and phase: Completed; Phase 3

Conditions: Hereditary Hemorrhagic Telangiectasia

Treatments: Drug: Tranexamic acid first, than placebo; Drug: First placebo, than Tranexamic acid.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01031992

141CHC9008-001 (Other Identifier)

TAHHT

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups

Group I

Experimental group

Description:

First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months.

Treatment:

Drug: Tranexamic acid first, than placebo

Group II

Experimental group

Description:

First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).

Treatment:

Drug: First placebo, than Tranexamic acid.