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OpenTrials
Completed

NCT Number: NCT01031992

Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

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.

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Key information

Conditions

Hereditary Hemorrhagic Telangiectasia Anemia Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Epistaxis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Telangiectasia, Hereditary Hemorrhagic Telangiectasis Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitätskliniken des Saarlandes, HNO-Abteilung

Homburg, Saarland, 66421, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic acid first, than placebo

Drug

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

First placebo, than Tranexamic acid.

Drug

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

Primary outcomes

  1. Change of hemoglobin level within the phases.

    Time frame: Beginning and end of each 3 months period.

Secondary outcomes

  1. Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)

    Time frame: Measured once a day during each 3 months period

Sponsors and collaborators

Lead sponsor

University Hospital, Saarland

Other

Collaborators

  • Baxter Healthcare Corporation
  • Pharmacia GmbH, Erlangen, Germany

Registry information

Official study title

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

Acronym: TAHHT

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Dec 15, 2009
Registry last updated
Dec 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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