stop_circleTerminated/Withdrawn
Blood Loss, Surgical, Postoperative Hemorrhage
Bayer Identifier:
11799
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
Trial purpose
The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
54Trial Dates
February 2006 - March 2007Phase
Phase 3Could I Receive a placebo
YesProducts
Trasylol (Aprotinin, BAYA0128)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Berlin, 13086, Germany | |
Completed | Barcelona, 08035, Spain | |
Completed | Barcelona, 08036, Spain | |
Completed | Windsor, N9A 1E1, Canada | |
Completed | Montreal, H3A 2B4, Canada | |
Completed | Berlin, 13353, Germany | |
Completed | Karlsbad, 76307, Germany | |
Completed | Münster, 48149, Germany | |
Completed | Neustadt, 23730, Germany | |
Completed | Barcelona, 08003, Spain | |
Completed | Valencia, 46010, Spain | |
Completed | Madrid, 28034, Spain | |
Completed | Pamplona, 31008, Spain | |
Completed | Oshawa, L1G 2B9, Canada | |
Withdrawn | Cuxhaven, 27476, Germany | |
Withdrawn | Birmingham, 35205, United States | |
Withdrawn | New York, 10003, United States | |
Withdrawn | Durham, 27710, United States | |
Withdrawn | Houston, 77074, United States | |
Withdrawn | Ann Arbor, 48109-0338, United States | |
Withdrawn | Englewood, 07631, United States | |
Withdrawn | Charlottesville, 22908, United States | |
Withdrawn | Cleveland, 44195, United States | |
Withdrawn | Indianapolis, 46260, United States | |
Withdrawn | Providence, 02908, United States | |
Withdrawn | Encinitas, 92024, United States | |
Withdrawn | Durham, 27704, United States | |
Withdrawn | BOBIGNY, 93009, France | |
Withdrawn | MONTPELLIER CEDEX, 34059, France | |
Withdrawn | PARIS, 75634, France | |
Withdrawn | LE KREMLIN BICETRE, 94270, France | |
Withdrawn | RENNES, 35000, France | |
Withdrawn | LILLE CEDEX, 59037, France | |
Withdrawn | LIMOGES CEDEX, 87042, France | |
Withdrawn | BORDEAUX, 33000, France | |
Withdrawn | LYON, 69394, France | |
Withdrawn | Sevilla, 41013, Spain | |
Withdrawn | Edmonton, T6G 2B7, Canada | |
Withdrawn | Halifax, B3H 3A7, Canada | |
Withdrawn | Toronto, M5T 2S8, Canada | |
Withdrawn | Winnipeg, R3A 1R9, Canada | |
Withdrawn | Sherbrooke, J1H 5N4, Canada |
Primary Outcome
- Percent of patients requiring a blood transfusion (blood or packed red blood cells, autologous or allogenic)date_rangeTime Frame:anytime in the intra-operative or postoperative period (up to the earlier of Day 7 or discharge).enhanced_encryptionnoSafety Issue:
Secondary Outcome
- The percent of patients receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or dischargedate_rangeTime Frame:surgery to dischargeenhanced_encryptionnoSafety Issue:
- The percent of patients 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 dischargedate_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 alonedate_rangeTime Frame:surgery to dischargeenhanced_encryptionnoSafety Issue:
- The number of units of blood or packed red cells transfused per patient requiring transfusiondate_rangeTime Frame:surgery to dischargeenhanced_encryptionnoSafety Issue:
- Drainage (in milliliters) from the operative site in the first 8 hours postoperatively, and total drainage until removal of drains or until hospital discharge (whichever is earlier)date_rangeTime Frame:surgery to dischargeenhanced_encryptionnoSafety Issue:
- Blood loss during surgery, based on qualitative and quantitative estimatesdate_rangeTime Frame:surgeryenhanced_encryptionnoSafety Issue:
- The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of Day 3, or, if transfused earlier, prior to transfusion).date_rangeTime Frame:pre-op and day 3 post surgeryenhanced_encryptionnoSafety Issue:
- Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar proceduresdate_rangeTime Frame:surgery to dischargeenhanced_encryptionnoSafety Issue:
- The percent of patients receiving colloid or other blood products, and the number of units transfuseddate_rangeTime Frame:surgery to dischargeenhanced_encryptionnoSafety Issue:
- Changes in blood markers related to inflammation and blood coagulationdate_rangeTime Frame:surgery to dischargeenhanced_encryptionnoSafety Issue:
- Changes in FEV1date_rangeTime Frame:surgery to dischargeenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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