Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

Phase 3

Completed

• Conditions: Hereditary Hemorrhagic Telangiectasia
• Interventions: Drug: Tranexamic acid first, than placebo; Drug: First placebo, than Tranexamic acid.

• Registration Number: NCT01031992
• Lead Sponsor: University Hospital, Saarland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2002-08
• Study Completion: 2002-10
• Status Verified: 2009-12
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-12
• Last Update Submitted: 2009-12-12
• Study First Posted: 2009-12-15
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group I	Tranexamic acid first, than placebo	First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months.
Group II	First placebo, than Tranexamic acid.	First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).

Primary Outcome Measures

Name	Time	Method
Change of hemoglobin level within the phases.	Beginning and end of each 3 months period.

Secondary Outcome Measures

Name	Time	Method
Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)	Measured once a day during each 3 months period

Trial Locations

Locations (1)

Universitätskliniken des Saarlandes, HNO-Abteilung; 🇩🇪 Homburg, Saar, Germany