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

December 12, 2009 updated by: University Hospital, Saarland

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saar
      • Homburg, Saar, Germany, 66421
        • Universitätskliniken des Saarlandes, HNO-Abteilung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Collaborators

Baxter Healthcare Corporation
Pharmacia GmbH, Erlangen, Germany

Investigators

  • Principal Investigator: Urban W Geisthoff, Priv.-Doz. Dr.med., Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

August 1, 2002

Study Completion (Actual)

October 1, 2002

Study Registration Dates

First Submitted

December 11, 2009

First Submitted That Met QC Criteria

December 12, 2009

First Posted (Estimate)

December 15, 2009

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 12, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAHHT
  • 141CHC9008-001 (Other Identifier: BfArM (German Federal Institute for Drugs and Medical Products))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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