check_circleStudy Completed
Blood Loss, Surgical
Bayer Identifier:
11694
ClinicalTrials.gov Identifier:
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
BothAge
18 YearsTrial summary
Enrollment Goal
359Trial Dates
February 2005 - January 2006Phase
Phase 3Could I Receive a placebo
YesProducts
Trasylol (Aprotinin, BAYA0128)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Capstone Clinical Trials, Inc. | Birmingham, 35205, United States |
Completed | Colorado Orthopaedic Consultants, PC | Aurora, 80012, United States |
Terminated | Intermountain Research Center | Boise, 83702, United States |
Terminated | Office of Dr. Paul Peters, Jr., MD | Dallas, 75231, United States |
Completed | Orthopedic Associates of Hartford, PC | Farmington, 06032, United States |
Completed | Jacksonville Orthopaedic Institute | Jacksonville Beach, 32250, United States |
Completed | Coastal Clinical Research, Inc | Mobile, 36608, United States |
Completed | Kalamazoo Orthopedics Clinic | Kalamazoo, 49009, United States |
Completed | Michigan Orthopedic Center | Ypsilanti, 48197, United States |
Terminated | St. Vincent Center for Joint Replacement | Indianapolis, 46260, United States |
Completed | University of Pittsburgh Medical Center Health System | Pittsburgh, 15213-2592, United States |
Terminated | Orthopedic Medical Group | San Diego, 92123, United States |
Completed | Office of Drs. Booth, Bartolozzi & Balderston, MDs | Philadelphia, 19107, United States |
Terminated | University of Puerto Rico | San Juan, 00935, United States |
Completed | All Florida Orthopaedic Associates | St. Petersburg, 33703, United States |
Terminated | Sarasota Orthopedic Associates | Sarasota, 34239, United States |
Terminated | Unlimited Research, LP | San Antonio, 78233, United States |
Completed | Gill Orthopedic Center | Lubbock, 79410, United States |
Completed | Scripps Clinic - Torrey Pines | La Jolla, 92037, United States |
Completed | Arizona Research Center, Inc. | Phoenix, 85023, United States |
Completed | Rothman Institute | Philadelphia, 19107, United States |
Completed | Center for Hip & Knee Surgery | Mooresville, 46158, United States |
Terminated | Duke University Medical Center | Durham, 27710, United States |
Terminated | University of Iowa Hospitals & Clinics | Iowa City, 52242-1089, United States |
Completed | Sinai Hospital of Baltimore | Baltimore, 21215, United States |
Completed | The Center: Orthopedic & Neurosurgical Care and Research | Bend, 97701, United States |
Completed | Bay Pines VA Healthcare System | Bay Pines, 33744, United States |
Completed | Sports Medicine and Orthopaedics Center | Greensboro, 27401, United States |
Terminated | Lubbock Sports Medicine | Lubbock, 79410, United States |
Completed | University of Massachusetts Memorial Medical Center | Worcester, 01655, United States |
Completed | ADA Medical, Ltd. | Oshawa, L1J 2J2, Canada |
Completed | Lakeridge Health-Oshawa | Oshawa, L1G 2B9, Canada |
Completed | University of Alberta Hospital | Edmonton, T6G 2B7, Canada |
Terminated | Guelph General Hospital | Guelph, N1E 4J4, Canada |
Completed | Grand River Hospital | Kitchener, N2G 1G3, Canada |
Completed | St. Paul's Hospital - Vancouver | Vancouver, V6Z 1Y6, Canada |
Completed | Hopital St-Francois d'Assise-CHUQ | Quebec, G1L 3L5, Canada |
Terminated | Dr. Everett Chalmers Hospital | Fredericton, E3B 5N5, Canada |
Completed | Queen Elizabeth II Health Sciences Centre | Halifax, B3H 3A7, Canada |
Completed | London Health Sciences Centre | London, N6A 5A5, Canada |
Terminated | Kelowna General Hospital | Kelowna, V1Y 1T2, Canada |
Terminated | York Central Hospital | Richmond 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 dischargeenhanced_encryptionnoSafety Issue:
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 dischargeenhanced_encryptionnoSafety Issue:
- 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 dischargeenhanced_encryptionnoSafety Issue:
- 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 dischargeenhanced_encryptionnoSafety Issue:
- The number of units of blood or packed red cells transfused per patient requiring transfusion.date_rangeTime Frame:surgery to dischargeenhanced_encryptionnoSafety Issue:
- 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 dischargeenhanced_encryptionnoSafety Issue:
- The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of postoperative Day 2, or, if transfused earlier, prior to transfusiondate_rangeTime Frame:pre-operative through day 2enhanced_encryptionnoSafety Issue:
- 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:surgeryenhanced_encryptionnoSafety Issue:
- Changes in blood markers related to inflammation and blood coagulationdate_rangeTime Frame:surgery to dischargeenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2