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The main objective of the study is to investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optivate® | Experimental | Optivate® (Human Coagulation Factor VIII) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optivate® (Human Coagulation Factor VIII) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incremental Recovery for plasma Factor VIII | Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG | 90 minutes after pre-operative bolus dose |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Haematologii, Akademia Medyczna w Gdansku, ul. | Debinki 7, 80-211 Gdansk | Poland | ||||
| Klinika Haematologii, Akademia Medyczna w Lublinie, ul. |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Dr K Jaczewskiego 8, 20-090, Lublin |
| Poland |
| Klinika Haematologii, Akademia Medyczna w Poznaniu, ul. | Szkolna 8/12, 61-833 Poznan | Poland |
| Haemophilia Centre, Addenbrooke's Hospital, Hills Road | Cambridge | CB2 2QQ | United Kingdom |
| Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| Haemophilia Centre, University Hospital, Queens Medical Centre, Clifton Boulevard | Nottingham | N67 2UH | United Kingdom |
| Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road | Sheffield | S10 2JF | United Kingdom |
| Haemophilia Centre, Southampton General Hospital, Tremona Road | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C568131 | optivate |
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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