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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 11, 2009

Last Updated Date

December 12, 2009

Start Date ^ICMJE

March 2002

Primary Completion Date

August 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01031992 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

Official Title ^ICMJE

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

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

improve anemia (lead to an increased hemoglobin level)
reduce nosebleeds.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hereditary Hemorrhagic Telangiectasia

Intervention ^ICMJE

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.

Study Arm (s)

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

Intervention: Drug: Tranexamic acid first, than placebo
Experimental: Group II
First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).

Intervention: Drug: First placebo, than Tranexamic acid.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2002

Primary Completion Date

August 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01031992

Other Study ID Numbers ^ICMJE

TAHHT, 141CHC9008-001

Has Data Monitoring Committee

Yes

Responsible Party

Universitätskliniken des Saarlandes

Study Sponsor ^ICMJE

University Hospital, Saarland

Collaborators ^ICMJE

Pharmacia GmbH, Erlangen, Germany
Baxter Healthcare Corporation

Investigators ^ICMJE

Principal Investigator:

Urban W Geisthoff, Priv.-Doz. Dr.med.

Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne

Information Provided By

University Hospital, Saarland

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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