stop_circleTerminated/Withdrawn

Blood Loss, Surgical, Postoperative Hemorrhage

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

Both

Age

18 Years
  • - Subjects requiring elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. One vertebral level is defined as encompassing two vertebral bodies and one inter-vertebral disc space, so that a contiguous spinal fusion involving 3 vertebral levels would include 4 vertebral bodies and 3 inter-vertebral disc spaces.
  • - 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, or if the subject received aprotinin, the subject should be excluded.- Subjects with a known or suspected allergy to aprotinin.
    - Subjects with sepsis or a known bone infection.- Subjects with known bone malignancy.
    - Subjects with a creatinine clearance less than 30mL/min as calculated by the Cockcroft-Gault formula.
    - 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.
    - Subjects whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit or hemoglobin values <24% or <8 g/dl, respectively).
    - Subjects who have participated in an investigational drug study within the past 30 days
    - Subjects with a history of deep vein thrombosis or pulmonary embolism.
    - Subjects who are pregnant or breast feeding.
    - Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening.
    - Women of childbearing potential who are not using a reliable method of contraception.
    - Planned use of other antifibrinolytic agents.
    - Subjects on chronic anticoagulant treatment with Vit K antagonists that cannot be temporarily discontinued for the surgical procedure (as per local practices).

Trial summary

Enrollment Goal
54
Trial Dates
February 2006 - March 2007
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Trasylol (Aprotinin, BAYA0128)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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_encryption
    Safety Issue:
    no

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 discharge
    date_rangeTime Frame:
    surgery to discharge
    enhanced_encryption
    Safety Issue:
    no
  • 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 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
  • 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 discharge
    enhanced_encryption
    Safety Issue:
    no
  • Blood loss during surgery, based on qualitative and quantitative estimates
    date_rangeTime Frame:
    surgery
    enhanced_encryption
    Safety Issue:
    no
  • 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 surgery
    enhanced_encryption
    Safety Issue:
    no
  • Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar procedures
    date_rangeTime Frame:
    surgery to discharge
    enhanced_encryption
    Safety Issue:
    no
  • The percent of patients receiving colloid or other blood products, and the number of units transfused
    date_rangeTime Frame:
    surgery to discharge
    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
  • Changes in FEV1
    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 in Patients Undergoing Elective Spinal Fusion Surgery
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2