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

Sponsor

University Hospital, Saarland (Other)

Overall Status

Completed

CT.gov ID

NCT01031992

Collaborator

Pharmacia GmbH, Erlangen, Germany (Other), Baxter Healthcare Corporation (Industry)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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

improve anemia (lead to an increased hemoglobin level)
reduce nosebleeds.

Condition or Disease	Intervention/Treatment	Phase
Hereditary Hemorrhagic Telangiectasia	Drug: Tranexamic acid first, than placebo Drug: First placebo, than Tranexamic acid.	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Tranexamic Acid Taken Orally in Patients With Hereditary Hemorrhagic Telangiectasia

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

Aug 1, 2002

Actual Study Completion Date :

Oct 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months.	Drug: Tranexamic acid first, than placebo For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.
Experimental: Group II First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).	Drug: First placebo, than Tranexamic acid. First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.

Arm

Intervention/Treatment

Experimental: Group I

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

Drug: Tranexamic acid first, than placebo

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

Experimental: Group II

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

Drug: First placebo, than Tranexamic acid.

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

Outcome Measures

Primary Outcome Measures

Change of hemoglobin level within the phases. [Beginning and end of each 3 months period.]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.