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

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ClinicalTrials.gov Identifier: NCT01031992
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : December 15, 2009
Sponsor:
Collaborators:
Pharmacia GmbH, Erlangen, Germany
Baxter Healthcare Corporation
Information provided by:
University Hospital, Saarland

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

  1. improve anemia (lead to an increased hemoglobin level)
  2. 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 Type : Interventional  (Clinical Trial)
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 : March 2002
Actual Primary Completion Date : August 2002
Actual Study Completion Date : October 2002


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.



Primary Outcome Measures :
  1. Change of hemoglobin level within the phases. [ Time Frame: Beginning and end of each 3 months period. ]

Secondary Outcome Measures :
  1. Mean epistaxis score (daily duration multiplied by mean subjective daily intensity) [ Time Frame: Measured once a day during each 3 months period ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031992


Locations
Germany
Universitätskliniken des Saarlandes, HNO-Abteilung
Homburg, Saar, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland
Pharmacia GmbH, Erlangen, Germany
Baxter Healthcare Corporation
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitätskliniken des Saarlandes
ClinicalTrials.gov Identifier: NCT01031992     History of Changes
Other Study ID Numbers: TAHHT
141CHC9008-001 ( Other Identifier: BfArM (German Federal Institute for Drugs and Medical Products) )
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009

Keywords provided by University Hospital, Saarland:
Hereditary hemorrhagic telangiectasia
Rendu-Osler-Weber syndrome
Epistaxis
Nosebleeds
Anemia
Tranexamic acid
Antifibrinolytics

Additional relevant MeSH terms:
Vascular Malformations
Telangiectasis
Telangiectasia, Hereditary Hemorrhagic
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants