Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) (TAHHT)
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.
|Hereditary Hemorrhagic Telangiectasia||Drug: Tranexamic acid first, than placebo Drug: First placebo, than Tranexamic acid.||Phase 3|
|Study Design:||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|
- Change of hemoglobin level within the phases. [ Time Frame: Beginning and end of each 3 months period. ]
- Mean epistaxis score (daily duration multiplied by mean subjective daily intensity) [ Time Frame: Measured once a day during each 3 months period ]
|Study Start Date:||March 2002|
|Study Completion Date:||October 2002|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031992
|Universitätskliniken des Saarlandes, HNO-Abteilung|
|Homburg, Saar, Germany, 66421|
|Principal Investigator:||Urban W Geisthoff, Priv.-Doz. Dr.med.||Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne|