Review

Building an immune-mediated coagulopathy consensus: early recognition and evaluation to enhance post-surgical patient safety

Paul Ness¹ , Michael Creer² , George M Rodgers³ , Joseph J Naoum⁴ , Kenneth Renkens⁵ , Stacy A Voils⁶ and W Allan Alexander⁷ for the Recognition, Evaluation and Treatment of Acquired Coagulopathy Consensus (RETACC) Panel

¹  Division of Hematology, Johns Hopkins Medicine, 600 North Wolfe Street, Carnegie 667, Baltimore, Maryland 21287, USA

²  Department of Pathology and Laboratory Medicine, St Louis University School of Medicine 1402 South Grand, St Louis, Missouri 63104, USA

³  Division of Hematology, University of Utah Health Sciences Center, 50 North Medical Center Drive, Salt Lake City, Utah 84132, USA

⁴  Division of Vascular Surgery, The Methodist Hosptial, 6560 Fannin Street, Suite 1006, Houston, Texas, 77030 USA

⁵  8402 Harcourt Road, Suite 400, Indianapolis, Indiana 46260, USA

⁶  Department of Pharmacy, Virginia Commonwealth University School of Pharmacy, 401 North 12th Street, PO Box 980042, Richmond, Virginia 23298-0042, USA

⁷  BioSurgery and Medical Affairs, ZymoGenetics, Inc, 1201 Eastlake Ave E, Seattle, Washington 98102, USA

author email corresponding author email

Patient Safety in Surgery 2009, 3:8doi:10.1186/1754-9493-3-8

Published:	22 May 2009

Abstract

Topical hemostats, fibrin sealants, and surgical adhesives are regularly used in a variety of surgical procedures involving multiple disciplines. Generally, these adjuncts to surgical hemostasis are valuable means for improving wound visualization, reducing blood loss or adding tissue adherence; however, some of these agents are responsible for under-recognized adverse reactions and outcomes. Bovine thrombin, for example, is a topical hemostat with a long history of clinical application that is widely used alone or in combination with other hemostatic agents. Hematologists and coagulation experts are aware that these agents can lead to development of an immune-mediated coagulopathy (IMC). A paucity of data on the incidence of IMC contributes to under-recognition and leaves many surgeons unaware that this clinical entity, originating from normal immune responses to foreign antigen exposure, requires enhanced post-operative vigilance and judicious clinical judgment to achieve best outcomes.

Postoperative bleeding may result from issues such as loosened ties or clips or the occurrence of a coagulopathy due to hemodilution, vitamin K deficiency, disseminated intravascular coagulation (DIC) or post-transfusion, post-shock coagulopathic states. Other causes, such as liver disease, may be ruled out by a careful patient history and common pre-operative liver function tests. Less common are coagulopathies secondary to pathologic immune responses. Such coagulopathies include those that may result from inherent patient problems such as patients with an immune dysfunction related to systemic lupus erythrematosus (SLE) or lymphoma that can invoke antibodies against native coagulation factors. Medical interventions may also provoke antibody formation in the form of self-directed anti-coagulation factor antibodies, that result in problematic bleeding; it is these iatrogenic post-operative coagulopathies, including those associated with bovine thrombin exposure and its clinical context, that this panel was convened to address.

The RETACC panel's goal was to attain a logical consensus by reviewing the scientific evidence surrounding IMC and to make recommendations for the clinical recognition, diagnosis and evaluation, and clinical management of these complications. In light of the under-recognition and under-reporting of IMC, and given the associated morbidity, utilization of health care resources, and potential economic impact to hospitals, the panel engaged in a detailed review of peer-reviewed reports of bovine thrombin associated IMC. From that clinical knowledge base, recommendations were developed to guide clinicians in the recognition, diagnosis, and management of this challenging condition.