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Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00327379
First received: May 16, 2006
Last updated: October 13, 2014
Last verified: October 2014
  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


Condition Intervention Phase
Blood Loss, Surgical
Postoperative Hemorrhage
Drug: Trasylol (Aprotinin, BAYA0128)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percent of patients requiring a blood transfusion (blood or packed red blood cells, autologous or allogenic) [ Time Frame: anytime in the intra-operative or postoperative period (up to the earlier of Day 7 or discharge). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: surgery to discharge ] [ Designated as 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 [ Time Frame: surgery to discharge ] [ Designated as 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 [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]
  • The number of units of blood or packed red cells transfused per patient requiring transfusion [ Time Frame: surgery to discharge ] [ Designated as 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) [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]
  • Blood loss during surgery, based on qualitative and quantitative estimates [ Time Frame: surgery ] [ Designated as 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). [ Time Frame: pre-op and day 3 post surgery ] [ Designated as safety issue: No ]
  • Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar procedures [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]
  • The percent of patients receiving colloid or other blood products, and the number of units transfused [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]
  • Changes in blood markers related to inflammation and blood coagulation [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]
  • Changes in FEV1 [ Time Frame: surgery to discharge ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: February 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Trasylol (Aprotinin, BAYA0128)
Infusion of aprotinin (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
Placebo Comparator: Arm 2 Drug: Placebo
Infusion of placebo (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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, 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327379

Locations
Canada, Ontario
Oshawa, Ontario, Canada, L1G 2B9
Windsor, Ontario, Canada, N9A 1E1
Canada, Quebec
Montreal, Quebec, Canada, H3A 2B4
Germany
Karlsbad, Baden-Württemberg / 275, Germany, 76307
Berlin, Berlin / 285, Germany, 13086
Berlin, Berlin / 285, Germany, 13353
Münster, Nordrhein-Westfalen / 298, Germany, 48149
Neustadt, Schleswig-Holstein / 306, Germany, 23730
Spain
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08003
Madrid, Spain, 28034
Pamplona, Spain, 31008
Valencia, Spain, 46010
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00327379     History of Changes
Other Study ID Numbers: 11799, EudraCT No. 2005-003999-38
Study First Received: May 16, 2006
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Bloodloss
Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery

Additional relevant MeSH terms:
Blood Loss, Surgical
Hemorrhage
Postoperative Hemorrhage
Intraoperative Complications
Pathologic Processes
Postoperative Complications
Aprotinin
Coagulants
Enzyme Inhibitors
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses
Trypsin Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014