Walter H. Dzik

Paucity of studies to support that abnormal coagulation test results predict bleeding in the setting of invasive procedures: an evidence‐based review

BACKGROUND: The literature was systematically reviewed to determine whether a prolonged prothrombin time or elevated international normalized ratio predicts bleeding during invasive diagnostic procedures.

Effect of fresh-frozen plasma transfusion on prothrombin time and bleeding in patients with mild coagulation abnormalities

BACKGROUND: Fresh‐frozen plasma (FFP) is frequently transfused to patients with mild prolongation of coagulation values under the assumption that FFP will correct the coagulopathy. There is little evidence to support this practice, however. To determine the effect of FFP on coagulation variables and correlation with bleeding in patients with mildly prolonged coagulation values, a prospective audit of all FFP transfusions at the Massachusetts General Hospital between September 2, 2004, and September 30, 2005, was performed.

A prospective, randomized clinical trial of universal WBC reduction.

BACKGROUND : Recipient exposure to allogeneic donor WBCs results in transfusion complications for selected populations of recipients. Whether or not WBC reduction should be universally applied is highly controversial.

Emily Cooley Lecture 2002: transfusion safety in the hospital

rimum non nocere (“First, do no harm”) is an ancient reminder that patients should not be subjected to unsafe or harmful medical practices. In recent years, concern over harm to patients has gained renewed attention. Patient injury and death due to errors resulting from unsafe processes in healthcare was highlighted by the 1999 Institute of Medicine’s report “To err is human.” 1 The need to reassert patient safety as a top priority cuts across all branches of healthcare and includes transfusion medicine. This paper summarizes the 2002 Emily Cooley lecture, which called for a realignment of priorities in the field of transfusion medicine away from excess attention to the component and toward the interests of the patient. Transfusion safety is concerned with the overall process of delivering transfusion care to the patient. During the past three decades, resources devoted to the quality of the blood component have resulted in impressive improvements in blood safety. However, overall transfusion safety, largely the province of hospitals, has received far less attention. As a result, serious problems exist at each step of the hospital process of transfusion care. High rates of mislabeled and completely miscollected patient samples have been documented. The physician’s decision to transfuse is hampered by the absence of controlled clinical trials and the absence of formal training in transfusion therapies. The final bedside check required to insure that the unit is intended for the recipient is often performed either incompletely or incorrectly, resulting in millions of unsafe transfusion episodes each year. Mistransfusion of blood remains the single most common serious hazard of transfusion, is the most likely cause of death attributed to transfusion, and occurs at a rate thousands of times higher than transfusion-transmitted HCV and HIV combined. Solutions to current problems in hospital transfusion safety can be grouped into three categories: First, new technology designed to improve patient safety should be explored. Machine-readable patient identification wristP bands, smart pumps, and radio-frequency smart labels may reduce transfusion errors. Nanotechnology holds great promise to improve clinical decision-making regarding transfusion, and computerized blood utilization review (CBUR) can provide timely and useful educational feedback to prescribing physicians. Second, a new position—the transfusion safety officer (TSO)—charged with the responsibility for improving the process of transfusion care outside the laboratory should be developed in the US. TSOs have already been deployed in several nations to identify and resolve latent organizational weakness leading to unsafe transfusion practice. Third, professional societies should become advocates for patient welfare by setting performance standards in key areas of the transfusion process including the collection of patient samples, bedside blood administration, and staffing levels in laboratories directly responsible for blood support of patients. Clinical research is urgently needed to define better the indications for transfusion and to explicitly evaluate proposed new safety interventions. Hospital transfusion safety represents a top priority for the profession of transfusion medicine.

Current usage of intravenous immune globulin and the rationale behind it: the Massachusetts General Hospital data and a review of the literature

BACKGROUND:  Intravenous immune globulin (IVIG) has been approved by the Food and Drug Administration (FDA) for use in 6 conditions: immune thrombocytopenic purpura (ITP), primary immunodeficiency, secondary immunodeficiency, pediatric HIV infection, Kawasaki disease, prevention of graft versus host disease (GVHD) and infection in bone marrow transplant recipients. However, most usage is for off‐label indications, and for some of these comprehensive guidelines have been published.

An international study of the performance of sample collection from patients

Background and Objectives Collection of a blood sample from the correct patient is the first step in the process of safe transfusion. The aim of this international collaborative study was to assess the frequency of mislabelled and miscollected samples drawn for blood grouping.

Fresh frozen plasma and platelet transfusion for nonbleeding patients in the intensive care unit: benefit or harm?

Objective:Whereas restrictive red cell transfusion has become a standard of care for the critically ill, evidenced-based indications for use of other blood components such as fresh frozen plasma (FFP) and platelet transfusions are limited. We searched the National Library of Medicine PubMed database as well as references of retrieved articles and summarized the current evidence for the use of FFP and platelet transfusions in critically ill patients. Results:Routine coagulation tests are poor determinants of bleeding risk in critically ill patients with coagulopathy. FFP transfusion has limited efficacy and is associated with significant morbidity in critically ill patients, in particular, pulmonary edema and acute lung injury. Routine minimally invasive critical care procedures can be safely performed by experienced clinicians in the setting of mildly abnormal coagulation test results, and there is no evidence that FFP transfusion alters the risk of bleeding. For platelet transfusion, the American Society of Clinical Oncology has developed practice guidelines designed for oncology patients. However, because the pathophysiology of thrombocytopenia in critically ill patients often differs from that of thrombocytopenia in oncology patients, published guidelines for oncology patients may not be applicable. Conclusion:Because the risk-benefit ratio of a liberal FFP or platelet transfusion strategy for critically ill patients may not be favorable, randomized controlled trials are warranted for evaluating a restrictive vs. liberal FFP or platelet transfusion strategy for nonbleeding patients in the intensive care unit.

Practical guidelines for process validation and process control of white cell-reduced blood components: report of the Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT)

Background: The increased use of white (WBC)‐reduced blood components has prompted many institutions to develop quality assurance programs directed to such component preparation processes. For consistent preparation of WBC‐reduced blood components that meet clinical needs as well as national standards, a program of process validation and control should be instituted. This involves controlling key factors that affect WBC reduction as well as periodic monitoring of the residual cellular content of components. Practical guidelines for the implementation of such a program are provided.

Clinical review: Canadian National Advisory Committee on Blood and Blood Products - Massive Transfusion Consensus Conference 2011: report of the panel

In June 2011 the Canadian National Advisory Committee on Blood and Blood Products sponsored an international consensus conference on transfusion and trauma. A panel of 10 experts and two external advisors reviewed the current medical literature and information presented at the conference by invited international speakers and attendees. The Consensus Panel addressed six specific questions on the topic of blood transfusion in trauma. The questions focused on: ratio-based blood resuscitation in trauma patients; the impact of survivorship bias in current research conclusions; the value of nonplasma coagulation products; the role of protocols for delivery of urgent transfusion; the merits of traditional laboratory monitoring compared with measures of clot viscoelasticity; and opportunities for future research. Key findings include a lack of evidence to support the use of 1:1:1 blood component ratios as the standard of care, the importance of early use of tranexamic acid, the expected value of an organized response plan, and the recommendation for an integrated approach that includes antifibrinolytics, rapid release of red blood cells, and a foundation ratio of blood components adjusted by results from either traditional coagulation tests or clot viscoelasticity or both. The present report is intended to provide guidance to practitioners, hospitals, and policy-makers.

New technology for transfusion safety

Hemovigilance programs from around the world document that the greatest risk to recipients of blood transfusion is human error, resulting in transfusion of the incorrect blood component. Errors in transfusion care have strong parallels with errors in medication administration. Errors often result from ‘lapse’ or ‘slip’ mistakes in which details of patient identification are overlooked. Three areas of transfusion are focal points for improved care: the labelling of the patients pre‐transfusion sample, the decision to transfuse and the final bedside check designed to prevent mis‐transfusion. Both barcodes and radio‐frequency identification technology, each ideally suited to matching alpha‐numeric identifiers, are being implemented in order to improve performance sample labelling and the bedside check. The decision to transfuse should ultimately be enhanced through the use of nanotechnology sensors, computerised order entry and decision support systems. Obstacles to the deployment of new technology include resistance to change, confusion regarding the best technology, and uncertainty regarding the return‐on‐investment. By focusing on overall transfusion safety, deploying validated systems appropriate for both medication and blood administration, thoughtful integration of technology into bedside practice and demonstration of improved performance, the application of new technologies will improve care for patients in need of transfusion therapy.