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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018049-19 | EudraCT Number |
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In a case series intranasal submucosal bevacizumab has been shown to reduce epistaxis in patients suffering from Hereditary Haemorrhagic Telangiectasia together with KTP Laser therapy. The aim of this study is to evaluate the effectiveness of submucosal intranasal bevacizumab compared to placebo in a randomized double blind trial setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bevacizumab | Experimental | submucosal intranasal bevacizumab on day 0 |
|
| placebo | Placebo Comparator | 0.9% NaCl intranasal submucosal on day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 100mg intranasal submucosal bevacizumab in 10ml |
| |
| Measure | Description | Time Frame |
|---|---|---|
| relative change in average daily Epistaxis VAS scores compared to baseline | Daily epistaxis VAS scores are recorded in a diary. The baseline score is the average daily epistaxis VAS score 4 weeks before treatment (day -28 to 0). This score is compared to the average daily VAS score day 10-84 posttreatment. The relative change of this average score compared to baseline is the primary outcome. | day 10 - 84 posttreatment |
| Measure | Description | Time Frame |
|---|---|---|
| Epistaxis Severity Score HHT-ESS compared to baseline | 3 months post treatment | |
| Epistaxis frequency, duration and severity compared to baseline | day 10 - 84 posttreatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für HNO, Medizinische Univeristät Wien | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24595923 | Derived | Riss D, Burian M, Wolf A, Kranebitter V, Kaider A, Arnoldner C. Intranasal submucosal bevacizumab for epistaxis in hereditary hemorrhagic telangiectasia: a double-blind, randomized, placebo-controlled trial. Head Neck. 2015 Jun;37(6):783-7. doi: 10.1002/hed.23655. Epub 2014 Apr 30. |
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| ID | Term |
|---|---|
| D004844 | Epistaxis |
| D013683 | Telangiectasia, Hereditary Hemorrhagic |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| NaCl |
| Drug |
10ml of 0.9% NaCl intranasal submucosal |
|
| Number of emergency department visits due to epistaxis compared to baseline |
| day 10 - 84 posttreatment |
| lab results (ferritin values, Hb, Hct) compared to baseline | day 84 posttreatment |
| Number of transfusions needed compared to baseline | day 10-84 posttreatment |
| Average daily epistaxis VAS scores compared to baseline among age groups and among groups with different epistaxis severity | day 10-84 posttreatment |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013684 | Telangiectasis |
| 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |