check_circleStudy Completed

Blood Loss, Surgical

Bayer Identifier:

11694

ClinicalTrials.gov Identifier:

NCT00668031

EudraCT Number:

Not Available

EU CT Number:

Not Available
Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

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

Enrollment Goal
359
Trial Dates
February 2005 - January 2006
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Trasylol (Aprotinin, BAYA0128)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Capstone Clinical Trials, Inc.Birmingham, 35205, United States
Completed
Colorado Orthopaedic Consultants, PCAurora, 80012, United States
Terminated
Intermountain Research CenterBoise, 83702, United States
Terminated
Office of Dr. Paul Peters, Jr., MDDallas, 75231, United States
Completed
Orthopedic Associates of Hartford, PCFarmington, 06032, United States
Completed
Jacksonville Orthopaedic InstituteJacksonville Beach, 32250, United States
Completed
Coastal Clinical Research, IncMobile, 36608, United States
Completed
Kalamazoo Orthopedics ClinicKalamazoo, 49009, United States
Completed
Michigan Orthopedic CenterYpsilanti, 48197, United States
Terminated
St. Vincent Center for Joint ReplacementIndianapolis, 46260, United States
Completed
University of Pittsburgh Medical Center Health SystemPittsburgh, 15213-2592, United States
Terminated
Orthopedic Medical GroupSan Diego, 92123, United States
Completed
Office of Drs. Booth, Bartolozzi & Balderston, MDsPhiladelphia, 19107, United States
Terminated
University of Puerto RicoSan Juan, 00935, United States
Completed
All Florida Orthopaedic AssociatesSt. Petersburg, 33703, United States
Terminated
Sarasota Orthopedic AssociatesSarasota, 34239, United States
Terminated
Unlimited Research, LPSan Antonio, 78233, United States
Completed
Gill Orthopedic CenterLubbock, 79410, United States
Completed
Scripps Clinic - Torrey PinesLa Jolla, 92037, United States
Completed
Arizona Research Center, Inc.Phoenix, 85023, United States
Completed
Rothman InstitutePhiladelphia, 19107, United States
Completed
Center for Hip & Knee SurgeryMooresville, 46158, United States
Terminated
Duke University Medical CenterDurham, 27710, United States
Terminated
University of Iowa Hospitals & ClinicsIowa City, 52242-1089, United States
Completed
Sinai Hospital of BaltimoreBaltimore, 21215, United States
Completed
The Center: Orthopedic & Neurosurgical Care and ResearchBend, 97701, United States
Completed
Bay Pines VA Healthcare SystemBay Pines, 33744, United States
Completed
Sports Medicine and Orthopaedics CenterGreensboro, 27401, United States
Terminated
Lubbock Sports MedicineLubbock, 79410, United States
Completed
University of Massachusetts Memorial Medical CenterWorcester, 01655, United States
Completed
ADA Medical, Ltd.Oshawa, L1J 2J2, Canada
Completed
Lakeridge Health-OshawaOshawa, L1G 2B9, Canada
Completed
University of Alberta HospitalEdmonton, T6G 2B7, Canada
Terminated
Guelph General HospitalGuelph, N1E 4J4, Canada
Completed
Grand River HospitalKitchener, N2G 1G3, Canada
Completed
St. Paul's Hospital - VancouverVancouver, V6Z 1Y6, Canada
Completed
Hopital St-Francois d'Assise-CHUQQuebec, G1L 3L5, Canada
Terminated
Dr. Everett Chalmers HospitalFredericton, E3B 5N5, Canada
Completed
Queen Elizabeth II Health Sciences CentreHalifax, B3H 3A7, Canada
Completed
London Health Sciences CentreLondon, N6A 5A5, Canada
Terminated
Kelowna General HospitalKelowna, V1Y 1T2, Canada
Terminated
York Central HospitalRichmond Hill, L4C 4Z3, Canada

Primary Outcome

  • 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)
    date_rangeTime Frame:
    intra-op tp discharge
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    surgery to discharge
    enhanced_encryption
    Safety Issue:
    no
  • 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.
    date_rangeTime Frame:
    surgery to discharge
    enhanced_encryption
    Safety Issue:
    no
  • 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.
    date_rangeTime Frame:
    surgery to discharge
    enhanced_encryption
    Safety Issue:
    no
  • The number of units of blood or packed red cells transfused per patient requiring transfusion.
    date_rangeTime Frame:
    surgery to discharge
    enhanced_encryption
    Safety Issue:
    no
  • 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.
    date_rangeTime Frame:
    surgery to discharge
    enhanced_encryption
    Safety Issue:
    no
  • The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of postoperative Day 2, or, if transfused earlier, prior to transfusion
    date_rangeTime Frame:
    pre-operative through day 2
    enhanced_encryption
    Safety Issue:
    no
  • Surgeon's assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures.
    date_rangeTime Frame:
    surgery
    enhanced_encryption
    Safety Issue:
    no
  • Changes in blood markers related to inflammation and blood coagulation
    date_rangeTime Frame:
    surgery to discharge
    enhanced_encryption
    Safety Issue:
    no

Trial design

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement Surgery
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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