Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

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.

Full Title of Study: “Efficacy of Tranexamic Acid Taken Orally in Patients With Hereditary Hemorrhagic Telangiectasia”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: August 2002

Interventions

• Drug: Tranexamic acid first, than placebo
  • For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.
• Drug: First placebo, than Tranexamic acid.
  • First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.

Arms, Groups and Cohorts

• Experimental: Group I
  • First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months.
• Experimental: Group II
  • First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).

Clinical Trial Outcome Measures

Primary Measures

• Change of hemoglobin level within the phases.
  • Time Frame: Beginning and end of each 3 months period.

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University Hospital, Saarland
• Collaborator
  • Pharmacia GmbH, Erlangen, Germany
• Provider of Information About this Clinical Study
  • Universitätskliniken des Saarlandes,
• Overall Official(s)
  • Urban W Geisthoff, Priv.-Doz. Dr.med., Principal Investigator, Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne