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

U

University Hospital, Saarland

Status and phase

Completed
Phase 3

Conditions

Hereditary Hemorrhagic Telangiectasia

Treatments

Drug: Tranexamic acid first, than placebo
Drug: First placebo, than Tranexamic acid.

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01031992
141CHC9008-001 (Other Identifier)
TAHHT

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

23 participants in 2 patient groups

Group I
Experimental group
Description:
First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months.
Treatment:
Drug: Tranexamic acid first, than placebo
Group II
Experimental group
Description:
First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).
Treatment:
Drug: First placebo, than Tranexamic acid.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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