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

NCT00668031 | Completed Phase 3

• 1 other identifier: 11694
• Study Type: interventional
• Target: 359
• Locations: 3 countries
• Sites: 40

Brief Summary

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.

Conditions

Blood Loss, Surgical

Keywords

Transfusion requirements; Hip replacement surgery; Prevention of blood loss; Bloodloss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• The number of units of blood or packed red cells transfused per patient requiring transfusion.

  surgery to discharge

• The estimated blood loss during surgery, drainage (in milliliters) from the operative site in the first six hours post-operatively, and total drainage until removal of drains.

  surgery to discharge

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Trasylol (Aprotinin, BAYA0128)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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

Arm 1

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

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects requiring elective primary total hip replacement surgery
• Documented, signed, dated informed consent obtained prior to any study specific procedures being performed

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (40)

Unknown Facility

Birmingham, Alabama, 35205, United States

Location

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Mobile, Alabama, 36608, United States

Location

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Phoenix, Arizona, 85023, United States

Location

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La Jolla, California, 92037, United States

Location

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San Diego, California, 92123, United States

Location

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Aurora, Colorado, 80012, United States

Location

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Farmington, Connecticut, 06032, United States

Location

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Bay Pines, Florida, 33744, United States

Location

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Jacksonville Beach, Florida, 32250, United States

Location

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Sarasota, Florida, 34239, United States

Location

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St. Petersburg, Florida, 33703, United States

Location

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Boise, Idaho, 83702, United States

Location

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Indianapolis, Indiana, 46260, United States

Location

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Mooresville, Indiana, 46158, United States

Location

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Iowa City, Iowa, 52242-1089, United States

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Baltimore, Maryland, 21215, United States

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Worcester, Massachusetts, 01655, United States

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Kalamazoo, Michigan, 49009, United States

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Ypsilanti, Michigan, 48197, United States

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Durham, North Carolina, 27710, United States

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Greensboro, North Carolina, 27401, United States

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Bend, Oregon, 97701, United States

Location

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Philadelphia, Pennsylvania, 19107, United States

Location

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Pittsburgh, Pennsylvania, 15213-2592, United States

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Dallas, Texas, 75231, United States

Location

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Lubbock, Texas, 79410, United States

Location

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San Antonio, Texas, 78233, United States

Location

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Edmonton, Alberta, T6G 2B7, Canada

Location

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Kelowna, British Columbia, V1Y 1T2, Canada

Location

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Vancouver, British Columbia, V6Z 1Y6, Canada

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Fredericton, New Brunswick, E3B 5N5, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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Guelph, Ontario, N1E 4J4, Canada

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Kitchener, Ontario, N2G 1G3, Canada

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London, Ontario, N6A 5A5, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Oshawa, Ontario, L1J 2J2, Canada

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Richmond Hill, Ontario, L4C 4Z3, Canada

Location

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Québec, Quebec, G1L 3L5, Canada

Location

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San Juan, 00935, Puerto Rico

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Aprotinin

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 28, 2008
• Study Start: February 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

CA (12); US (27); PR (1)