Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

Phase 3CompletedNCT01031992

University Hospital, Saarland23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hereditary Hemorrhagic Telangiectasia

Interventions

Tranexamic acid first, than placeboDRUG

For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.

First placebo, than Tranexamic acid.DRUG

First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Universitätskliniken des Saarlandes, HNO-Abteilung

Homburg, Saarland, Germany

Outcomes

Primary Outcomes

Change of hemoglobin level within the phases.

Time frame: Beginning and end of each 3 months period.

Secondary Outcomes

Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)

Time frame: Measured once a day during each 3 months period

Data from ClinicalTrials.gov

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