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Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

NCT ID: NCT01031992

Last Updated: 2009-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2002-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hereditary Hemorrhagic Telangiectasia

Keywords

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Hereditary hemorrhagic telangiectasia Rendu-Osler-Weber syndrome Epistaxis Nosebleeds Anemia Tranexamic acid Antifibrinolytics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group I

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

Group Type EXPERIMENTAL

Tranexamic acid first, than placebo

Intervention Type DRUG

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

Group II

First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).

Group Type EXPERIMENTAL

First placebo, than Tranexamic acid.

Intervention Type DRUG

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

Interventions

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Tranexamic acid first, than placebo

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

Intervention Type DRUG

First placebo, than Tranexamic acid.

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmacia GmbH, Erlangen, Germany

UNKNOWN

Sponsor Role collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

University Hospital, Saarland

OTHER

Sponsor Role lead

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Universitätskliniken des Saarlandes, HNO-Abteilung

Homburg, Saarland, Germany

Site Status

Countries

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Germany

References

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Geisthoff UW, Seyfert UT, Kubler M, Bieg B, Plinkert PK, Konig J. Treatment of epistaxis in hereditary hemorrhagic telangiectasia with tranexamic acid - a double-blind placebo-controlled cross-over phase IIIB study. Thromb Res. 2014 Sep;134(3):565-71. doi: 10.1016/j.thromres.2014.06.012. Epub 2014 Jun 16.

Reference Type DERIVED
PMID: 25005464 (View on PubMed)

Other Identifiers

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141CHC9008-001

Identifier Type: OTHER

Identifier Source: secondary_id

TAHHT

Identifier Type: -

Identifier Source: org_study_id