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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1122-5019 | Other Identifier | WHO |
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This observational registry is conducted in Europe, Asia, Africa and the United States of America (USA).
The purpose of the registry is to evaluate the efficacy and safety of activated recombinant human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or present refractoriness to platelet transfusions. Attention will be directed towards complications related to thrombo-embolic events and concomitant medications especially antifibrinolytics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | A prospective, observational multi-national registry collecting data and evaluating the efficacy and safety of rFVIIa in patients with GT with past or present refractoriness to platelet transfusions. The registry will also collect data from a broader range of GT patients treated with systemic haemostatic treatment (with or without antifibrinolytic drugs or other agents) used in the clinics. Data collection will continue for a maximum of six years. Baseline data as well as data obtained during either bleeding episodes or invasive procedures/surgeries will be recorded in the registry. |
| Measure | Description | Time Frame |
|---|---|---|
| For bleeding episodes: Overall efficacy evaluated by the caregiver/patient | within 30 days of end of treatment | |
| For surgery including invasive and dental procedures: Haemoglobin level | prior to surgery and 24 hours after surgery | |
| For surgery including invasive and dental procedures: Overall haemostatic evaluation by the surgeon | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in laboratory parameters (prothrombin time, platelet count, fibrinogen), if available | at the time of administration and two hours after the administration of rFVIIa | |
| Adverse Events (AEs) | during treatment episodes |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with GT. There is no limit to the number of bleeding episodes or preventions of bleeding during invasive procedures/surgery that can be entered for each patient within the lifetime of the registry. Patients will receive standard care according to local practice, thus any systemic haemostatic treatment (with or without antifibrinolytic drugs or other agents) considered useful by the centres for treatment of GT, are included in the registry.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Clinical Trial Call Center | Princeton | New Jersey | 08540 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36924249 | Derived | Poon MC, D'Oiron R, Baby S, Zotz RB, Di Minno G. The Glanzmann Thrombasthenia Registry: safety of platelet therapy in patients with Glanzmann thrombasthenia and changes in alloimmunization status. Haematologica. 2023 Oct 1;108(10):2855-2858. doi: 10.3324/haematol.2022.281973. No abstract available. | |
| 31523745 | Derived |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| Serious Adverse Events (SAEs) | during treatment episodes |
| Algiers |
| 16035 |
| Algeria |
| Vienna | A-1010 | Austria |
| Brussels | 1070 | Belgium |
| Sofia | 1407 | Bulgaria |
| Paris La Défense Cedex | 92932 | France |
| Mainz | 55127 | Germany |
| Budapest | 1025 | Hungary |
| Rome | 00144 | Italy |
| Alphen aan den Rijn | Netherlands |
| Karachi | Pakistan |
| Madrid | 28033 | Spain |
| Malmö | 202 15 | Sweden |
| Zurich | CH-8050 | Switzerland |
| Crawley | RH11 9RT | United Kingdom |
| Zotz RB, Poon MC, Di Minno G, D'Oiron R; Glanzmann Thrombasthenia Registry Investigators. The International Prospective Glanzmann Thrombasthenia Registry: Pediatric Treatment and Outcomes. TH Open. 2019 Sep 12;3(3):e286-e294. doi: 10.1055/s-0039-1696657. eCollection 2019 Jul. |
| 26001793 | Derived | Di Minno G, Zotz RB, d'Oiron R, Bindslev N, Di Minno MN, Poon MC; Glanzmann Thrombasthenia Registry Investigators. The international, prospective Glanzmann Thrombasthenia Registry: treatment modalities and outcomes of non-surgical bleeding episodes in patients with Glanzmann thrombasthenia. Haematologica. 2015 Aug;100(8):1031-7. doi: 10.3324/haematol.2014.121475. Epub 2015 May 22. |
| 26001792 | Derived | Poon MC, d'Oiron R, Zotz RB, Bindslev N, Di Minno MN, Di Minno G; Glanzmann Thrombasthenia Registry Investigators. The international, prospective Glanzmann Thrombasthenia Registry: treatment and outcomes in surgical intervention. Haematologica. 2015 Aug;100(8):1038-44. doi: 10.3324/haematol.2014.121384. Epub 2015 May 22. |
| ID | Term |
|---|---|
| D013915 | Thrombasthenia |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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