Back to resultsTranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) (TAHHT)
Primary Purpose
Hereditary Hemorrhagic Telangiectasia
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Tranexamic acid first, than placebo
First placebo, than Tranexamic acid.
Sponsored by
About this trial
This is an interventional treatment trial for Hereditary Hemorrhagic Telangiectasia focused on measuring Hereditary hemorrhagic telangiectasia, Rendu-Osler-Weber syndrome, Epistaxis, Nosebleeds, Anemia, Tranexamic acid, Antifibrinolytics
Eligibility 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.
Sites / Locations
- Universitätskliniken des Saarlandes, HNO-Abteilung
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group I
Group II
Arm Description
First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months.
First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).
Outcomes
Primary Outcome Measures
Change of hemoglobin level within the phases.
Secondary Outcome Measures
Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)
Full Information
NCT ID
NCT01031992
First Posted
December 11, 2009
Last Updated
December 12, 2009
Sponsor
University Hospital, Saarland
Collaborators
Pharmacia GmbH, Erlangen, Germany, Baxter Healthcare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01031992
Brief Title
Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
Acronym
TAHHT
Official Title
Efficacy of Tranexamic Acid Taken Orally in Patients With Hereditary Hemorrhagic Telangiectasia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
October 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Saarland
Collaborators
Pharmacia GmbH, Erlangen, Germany, Baxter Healthcare Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Hemorrhagic Telangiectasia
Keywords
Hereditary hemorrhagic telangiectasia, Rendu-Osler-Weber syndrome, Epistaxis, Nosebleeds, Anemia, Tranexamic acid, Antifibrinolytics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months.
Arm Title
Group II
Arm Type
Experimental
Arm Description
First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid first, than placebo
Intervention Description
For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.
Intervention Type
Drug
Intervention Name(s)
First placebo, than Tranexamic acid.
Intervention Description
First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.
Primary Outcome Measure Information:
Title
Change of hemoglobin level within the phases.
Time Frame
Beginning and end of each 3 months period.
Secondary Outcome Measure Information:
Title
Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)
Time Frame
Measured once a day during each 3 months period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urban W Geisthoff, Priv.-Doz. Dr.med.
Organizational Affiliation
Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätskliniken des Saarlandes, HNO-Abteilung
City
Homburg
State/Province
Saar
ZIP/Postal Code
66421
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25005464
Citation
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.
Results Reference
derived
Learn more about this trial
Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
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