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

This study has been completed.
Sponsor:
Collaborators:
Pharmacia GmbH, Erlangen, Germany
Baxter Healthcare Corporation
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01031992
First received: December 11, 2009
Last updated: December 12, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Hereditary Hemorrhagic Telangiectasia
Drug: Tranexamic acid first, than placebo
Drug: First placebo, than Tranexamic acid.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Tranexamic Acid Taken Orally in Patients With Hereditary Hemorrhagic Telangiectasia

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • Change of hemoglobin level within the phases. [ Time Frame: Beginning and end of each 3 months period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean epistaxis score (daily duration multiplied by mean subjective daily intensity) [ Time Frame: Measured once a day during each 3 months period ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: March 2002
Study Completion Date: October 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University Hospital, Saarland

Additional 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
Study First Received: December 11, 2009
Last Updated: December 12, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on November 27, 2014