Trial Condition(s):
Blood Loss, Surgical
Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
Bayer Identifier:
11694
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Capstone Clinical Trials, Inc. Birmingham, United States, 35205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Colorado Orthopaedic Consultants, PC Aurora, United States, 80012 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Intermountain Research Center Boise, United States, 83702 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Paul Peters, Jr., MD Dallas, United States, 75231 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orthopedic Associates of Hartford, PC Farmington, United States, 06032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jacksonville Orthopaedic Institute Jacksonville Beach, United States, 32250 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Coastal Clinical Research, Inc Mobile, United States, 36608 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kalamazoo Orthopedics Clinic Kalamazoo, United States, 49009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Michigan Orthopedic Center Ypsilanti, United States, 48197 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Vincent Center for Joint Replacement Indianapolis, United States, 46260 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Pittsburgh Medical Center Health System Pittsburgh, United States, 15213-2592 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orthopedic Medical Group San Diego, United States, 92123 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Drs. Booth, Bartolozzi & Balderston, MDs Philadelphia, United States, 19107 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Puerto Rico San Juan, United States, 00935 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations All Florida Orthopaedic Associates St. Petersburg, United States, 33703 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sarasota Orthopedic Associates Sarasota, United States, 34239 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Unlimited Research, LP San Antonio, United States, 78233 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gill Orthopedic Center Lubbock, United States, 79410 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scripps Clinic - Torrey Pines La Jolla, United States, 92037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arizona Research Center, Inc. Phoenix, United States, 85023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rothman Institute Philadelphia, United States, 19107 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Hip & Knee Surgery Mooresville, United States, 46158 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Duke University Medical Center Durham, United States, 27710 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Iowa Hospitals & Clinics Iowa City, United States, 52242-1089 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sinai Hospital of Baltimore Baltimore, United States, 21215 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Center: Orthopedic & Neurosurgical Care and Research Bend, United States, 97701 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bay Pines VA Healthcare System Bay Pines, United States, 33744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sports Medicine and Orthopaedics Center Greensboro, United States, 27401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lubbock Sports Medicine Lubbock, United States, 79410 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Massachusetts Memorial Medical Center Worcester, United States, 01655 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ADA Medical, Ltd. Oshawa, Canada, L1J 2J2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lakeridge Health-Oshawa Oshawa, Canada, L1G 2B9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Alberta Hospital Edmonton, Canada, T6G 2B7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Guelph General Hospital Guelph, Canada, N1E 4J4 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Grand River Hospital Kitchener, Canada, N2G 1G3 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Paul's Hospital - Vancouver Vancouver, Canada, V6Z 1Y6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital St-Francois d'Assise-CHUQ Quebec, Canada, G1L 3L5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Everett Chalmers Hospital Fredericton, Canada, E3B 5N5 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth II Health Sciences Centre Halifax, Canada, B3H 3A7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations London Health Sciences Centre London, Canada, N6A 5A5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kelowna General Hospital Kelowna, Canada, V1Y 1T2 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations York Central Hospital Richmond Hill, Canada, L4C 4Z3 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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)Timeframe: intra-op tp discharge
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.Timeframe: 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.Timeframe: 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.Timeframe: surgery to discharge
- The number of units of blood or packed red cells transfused per patient requiring transfusion.Timeframe: 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.Timeframe: surgery to discharge
- The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of postoperative Day 2, or, if transfused earlier, prior to transfusionTimeframe: pre-operative through day 2
- Surgeon's assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures.Timeframe: surgery
- Changes in blood markers related to inflammation and blood coagulationTimeframe: surgery to discharge
Additional Information
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