Evaluating the Efficacy, Immunogenicity, and Safety of Topical Thrombins in Surgery
Release Date: June 1, 2009 Expiration Date: June 30, 2010
NEEDS STATEMENT
Minimal blood loss is a hallmark of successful surgery. Despite the availability of common techniques, such as suture ligation, electrocautery, and simple pressure, bleeding continues to be a challenge during surgery. In these cases, topical hemostatic adjuncts are frequently employed to promote coagulation and achieve hemostasis. Topical thrombins from 3 distinct biologic origins—bovine, human plasma–derived, and recombinant human—make up one group of agents used to achieve hemostasis when standard surgical techniques have proven ineffective. Evidence from recently published clinical trials regarding the relative efficacy, immunogenicity, and safety of these 3 agents is timely and appropriate for clinicians managing outcomes and improving patient care during surgery.
ACCREDITATION STATEMENTS
Physician: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc. and Applied Clinical Education. AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians. AKH Inc. designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Pharmacy: AKH Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. AKH Inc. approves this knowledge-based activity for 1.5 contact hours (0.15 CEUs). UAN 077-999-09-024-H01-P.
Nurse: AKH Inc. is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation (ANCC-COA).
AKH Inc. designates this educational activity for 1.5 contact hour(s) (0.15 CEU). Accreditation applies solely to educational activities and does not imply approval or endorsement of any commercial product by the ANCC-COA.
LEARNING OBJECTIVES
At the completion of this activity, participants should be able to:
- Differentiate the active components in currently available topical thrombin preparations.
- Review recent data on the relative efficacy of topical thrombins used to control surgical bleeding.
- Explain the accumulated data on antibody development with available topical thrombins and potential clinical implications.
- Delineate the potential perioperative complications associated with available thrombins.
- Describe the diagnosis and treatment of immune-mediated coagulopathy in surgical patients.
TARGET AUDIENCE
This activity is intended for physicians, pharmacists, and nurses involved in the care of surgical patients.
CONFLICT OF INTEREST STATEMENT
It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The faculty must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflict of interest is resolved by AKH Inc. prior to certification of the activity. AKH planners and reviewers have no relevant financial relationships to disclose.
DISCLOSURE OF UNLABELED USE
This educational activity contains discussion of published and/or investigational uses of topical thrombins in the management of perioperative bleeding and of immunologic agents in the management of bovine thrombin¿induced immunemediated coagulopathy. Some uses of these agents have not been approved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
ESTIMATED TIME OF COMPLETION
This activity should take approximately 90 minutes to complete.
METHOD OF PARTICIPATION
There are no fees for participating in and receiving credit for this activity. The participant should, in order, read the objectives and monograph, answer the multiple-choice online post-test and complete the evaluation form. The evaluation form provides each participant with the opportunity to comment on the quality of the instructional process, the perception of enhanced professional effectiveness, the perception of commercial bias, and his/her views on future educational needs. A score of at least 70% is required to successfully complete this activity. One retake is allowed. Credit is available through June 30, 2010.
FACULTY
Larry W. Kraiss, MD
Professor and Chief
Division of Vascular Surgery
University of Utah Health Sciences Center
Salt Lake City, Utah
George M. Rodgers, MD, PhD
Professor of Medicine and Pathology
Division of Hematology and Division of Oncology
University of Utah Health Sciences Center
Salt Lake City, Utah
Stacy A. Voils, PharmD, BCPS
Critical Care Specialist, Neurosurgery
Virginia Commonwealth University Health System
Clinical Assistant Professor
Virginia Commonwealth University
Medical College of Virginia Hospitals
Richmond, Virginia
INDEPENDENT REVIEWER
Jeffrey H. Lawson, MD, PhD
Associate Professor of Surgery
Assistant Professor of Pathology
Director of the Vascular Research Laboratory
Director of Clinical Trials in Vascular Surgery
Duke University Medical Center
Durham, North Carolina
MEDICAL WRITER
Oren Traub, MD, PhD
FACULTY DISCLOSURE
Dr. Voils has disclosed that he has served on the speakers' bureau and the advisory committee of ZymoGenetics, Inc.
Dr. Rodgers has disclosed that he has served on the speakers' bureau of Alexion Pharmaceuticals, Inc., GlaxoSmithKline, Watson, and ZymoGenetics, Inc. He also has served on the advisory committee of Amgen and ZymoGenetics, Inc.
Dr. Kraiss has disclosed that he has served on the speakers' bureau, the advisory committee, and as a consultant for ZymoGenetics, Inc.
Dr. Lawson has disclosed that he is on the advisory committee for Baxter, Johnson and Johnson, Novo Nordisk, and ZymoGenetics, Inc.
Dr. Traub has no relevant commercial interests to disclose.
DISCLAIMER
This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc., the author(s), and the publisher specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, undetected error, or reader's misunderstanding of the content.
SOFTWARE REQUIREMENTS
PC
Microsoft Windows 2000 SE or above.
Internet Explorer (v5.5 or greater), or Firefox
Adobe Acrobat Reader*
MAC
MAC OS 10.2.8
Safari
Adobe Acrobat Reader*
Internet Explorer is not supported on the Macintosh.
* Required to view printable (PDF) version of the lesson.
Jointly sponsored by AKH Inc. and Applied Clinical Education.
This activity is made possible by an educational grant from ZymoGenetics, Inc.

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