Approval Probability
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Adjusted LOA
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Trasylol · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Trasylol (Aprotinin, BAYA0128) | DRUG | A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of aprotinin using an IV infusion pump |
| Placebo | DRUG | A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of of placebo using an IV infusion pump |
Inclusion Criteria: * Subjects requiring elective primary total hip replacement surgery * Documented, signed, dated informed consent obtained prior to any study specific procedures being performed Exclusion Criteria: * Subjects with previous exposure to aprotinin in the last 6 months. If the subj...
Trasylol is used to reduce blood loss and transfusion requirements in surgical patients. It was studied in patients undergoing elective primary total hip replacement, where the goal was to limit bleeding during and after surgery. It is a small molecule drug developed by Bayer AG.
Trasylol is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the company associated with the drug's clinical development program in surgical blood loss.
Trasylol is in Phase 3 development for blood loss in surgical patients. One Phase 3 trial has been completed, and no trials are currently active. The completed study was randomized, double blind, and placebo controlled, enrolling 359 patients.
Trasylol has been evaluated in the Phase 3 trial NCT00668031, titled Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement. The trial enrolled 359 patients across the United States, Canada, and Puerto Rico and has been completed.
Yes, Trasylol is also known as aprotinin and by the code name BAYA0128. These names refer to the same small molecule drug developed by Bayer AG for reducing blood loss in surgical patients.
Trasylol is an investigational drug in clinical development, with Phase 3 testing completed for blood loss in surgical patients. The completed trial, NCT00668031, was randomized, double blind, and placebo controlled, enrolling 359 patients aged 18 years and older.