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Trasylol

Phase 3

Blood Loss, Surgical | Small molecule | Other |Bayer AG|Last Updated: Dec 30, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment359

FDA Designations

No designations recorded

Clinical trial landscape

Trasylol · 1 trial · 1 indication

Phase 3 1
NCT00668031Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip ReplacementBlood Loss, Surgical
COMPLETED359 Analytics
PHASE3COMPLETED
Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
Blood Loss, SurgicalUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent of subjects requiring a blood transfusion (predonated blood or packed red blood cells, autologous or allogenic) anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
intra-op tp discharge

Secondary Endpoints

The percent of subjects receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge.
surgery to discharge
The percent of subjects who did and did not predonate blood receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge.
surgery to discharge
The number of units of blood or packed red cells transfused. There will be analyses for the combination of autologous and allogenic transfusion and for allogenic alone.
surgery to discharge
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Trasylol (Aprotinin, BAYA0128)DRUGA 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
PlaceboDRUGA 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
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites40

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...

Countries:United StatesCanadaPuerto Rico
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Frequently asked questions about Trasylol

What is Trasylol used for?

Trasylol is used to reduce blood loss and transfusion requirements in patients undergoing elective primary total hip replacement surgery. It is a small molecule drug being developed by Bayer AG for the therapeutic area of blood loss and surgical indications.

Who makes Trasylol?

Trasylol is being developed by Bayer AG, a pharmaceutical company listed on the stock exchange under the ticker BAYRY. The drug is currently in Phase 3 clinical development for reducing blood loss during surgical procedures.

What phase is Trasylol in?

Trasylol is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its ability to reduce blood loss and transfusion needs in patients undergoing elective primary total hip replacement.

What clinical trials is Trasylol in?

Trasylol has one completed Phase 3 clinical trial registered under NCT00668031. This trial, titled 'Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement,' enrolled 359 participants across the United States, Canada, and Puerto Rico.

Is Trasylol the same as aprotinin?

Trasylol is the brand name for aprotinin, a small molecule drug. The clinical trial NCT00668031 specifically evaluates the effect of aprotinin on transfusion requirements and blood loss, confirming that Trasylol and aprotinin refer to the same active substance.