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| ID | Type | Description | Link |
|---|---|---|---|
| 141CHC9008-001 | Other Identifier | BfArM (German Federal Institute for Drugs and Medical Products) |
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| Name | Class |
|---|---|
| Pharmacia GmbH, Erlangen, Germany | UNKNOWN |
| Baxter Healthcare Corporation | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months. |
|
| Group II | Experimental | First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid first, than placebo | Drug | For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of hemoglobin level within the phases. | Beginning and end of each 3 months period. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean epistaxis score (daily duration multiplied by mean subjective daily intensity) | Measured once a day during each 3 months period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Urban W Geisthoff, Priv.-Doz. Dr.med. | Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätskliniken des Saarlandes, HNO-Abteilung | Homburg | Saarland | 66421 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25005464 | Derived | 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. |
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| ID | Term |
|---|---|
| D013683 | Telangiectasia, Hereditary Hemorrhagic |
| D004844 | Epistaxis |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013684 | Telangiectasis |
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| First placebo, than Tranexamic acid. | Drug | First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months. |
|
| D006474 |
| Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |