Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement

Bayer

Status and phase: Completed; Phase 3

Conditions: Blood Loss, Surgical

Treatments: Drug: Placebo; Drug: Trasylol (Aprotinin, BAYA0128)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668031

11694

Details and patient eligibility

About

The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during surgery, is safe and can help reduce the amount of bleeding and the need for a blood transfusion during hip replacement surgery. Patients undergoing major surgery are at risk for significant blood loss. Because of this, there is a need for drugs that will help slow the amount of bleeding during surgery.

Enrollment: 359 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, subject should be excluded. If during cardiac surgery in the last 6 months, there is a record of aprotinin administration, subject should be excluded
• Subjects with a known or suspected allergy to aprotinin - Subjects with impaired renal function (serum creatinine > 3.5 mg/dl or 309 micromoles/liter)
• Subjects with a history of bleeding diathesis or known coagulation factor deficiency
• Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
• Subjects who refuse to receive allogenic blood products for religious or other reasons

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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359 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Trasylol (Aprotinin, BAYA0128)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo