Practice Guidelines for Blood Component Therapy

Developed by the Task Force on Blood Component Therapy: Linda C. Stehling, MD, (Chair), Scottsdale, Arizona; Dennis C. Doherty, D.O., Atlanta, Georgia; Ronald J. Faust, MD, Rochester, Minnesota; A. Gerson Greenburg, MD, Ph.D. (Representative, American College of Surgeons), Providence, Rhode Island; Chantal R. Harrison, MD (Representative, College of American Pathologists), San Antonio, Texas; Dennis F. Landers, MD, Dallas, Texas; Russell K. Laros, Jr., MD (Representative, American College of Obstetricians and Gynecologists), San Francisco, California; Ellison C. Pierce, Jr., MD, Boston, Massachusetts; Randall S. Prust, MD, Tucson, Arizona; Andrew D. Rosenberg, MD, New York, New York; Richard B. Weiskopf, MD, San Francisco, California; Steven H. Woolf, MD, M.P.H. (Methodologist), Fairfax, Virginia; and John F. Zeiger, MD, Ft. Wayne, Indiana.Submitted for publication November 1, 1995. Accepted for publication November 7, 1995. Supported by the American Society of Anesthesiologists, under the direction of James F. Arens, MD, Chairman of the Committee on Practice Parameters. Approved by the House of Delegates, October 25, 1995.Address correspondence to Dr. Stehling: 6210 East Oak Street, Scottsdale, Arizona, 85252–1867.Address reprint requests to the American Society of Anesthesiologists: 520 North Northwest Highway, Park Ridge, Illinois 60068–2573.MORE than 22 million blood components are transfused each year in the United States. 1Many of these transfusions are administered to surgical and obstetric patients. The transfusion of red blood cells (RBCs), platelets, fresh-frozen plasma (FFP), and cryoprecipitate has the potential of improving clinical outcomes in perioperative and peripartum settings. These benefits include improved tissue oxygenation and decreased bleeding. However, transfusions are not without risks or costs. The transmission of infectious diseases (e.g., hepatitis, human immunodeficiency virus (HIV) infection), hemolytic and nonhemolytic transfusion reactions, immunosuppression, alloimmunization, and other complications are potential sequelae of blood component therapy.A number of groups have issued clinical practice guidelines for blood component therapy in an effort to improve transfusion practices, minimize the incidence of adverse transfusion reactions, and decrease costs. In the 1980s, the National Institutes of Health convened consensus conferences and published recommendations for RBC transfusion, platelet therapy, and the administration of FFP. 2–4In 1984, the American College of Obstetricians and Gynecologists (ACOG) issued recommendations on blood component therapy. 5In 1990, the Transfusion Practices Committee of the American Association of Blood Banks issued guidelines for transfusion of patients undergoing coronary artery bypass surgery. 6In 1992, the American College of Physicians (ACP) issued recommendations for RBC transfusion. 7In 1994, the College of American Pathologists (CAP) published a practice parameter for FFP, cryoprecipitate, and platelet transfusion. 8Guidelines for blood utilization review were published in the same year by the American Association of Blood Banks. 9Although these documents include sections on the use of blood components in the surgical setting, no group has issued current and comprehensive recommendations on perioperative and peripartum blood component therapy.In 1994, the American Society of Anesthesiologists convened the Task Force on Blood Component Therapy to develop evidence-based guidelines on the proper indications for perioperative and peripartum administration of RBCs, platelets, FFP, and cryoprecipitate. The task force included nine anesthesiologists (in private and university-based practice); one physician representative from the American College of Surgeons, College of American Pathologists, and ACOG; and a methodologist.Before the guidelines were developed, the task force reviewed published evidence regarding the clinical effectiveness of perioperative and peripartum blood component therapy. A total of 1,417 articles were retrieved in a computerized and manual literature search conducted in mid-1994. The computerized search sought all English-language literature published in any country on the use of RBCs, platelets, FFP, or cryoprecipitate in the perioperative or peripartum setting. A total of 160 articles were considered relevant. Published evidence was considered relevant if it addressed the perioperative or peripartum use of the above blood components and measured effectiveness in terms of clinical outcomes. The strength of evidence was classified by study design category, using the scale in Table 1. Further details about the literature review methodology are available on request. Input from practicing anesthesiologists was obtained at an open forum held in October 1994. The document was sent to members of the American Society of Anesthesiologists House of Delegates, Board of Directors, and Component Society Presidents for review. The overall guideline development process is reviewed elsewhere. 10,11.This article summarizes the results of the literature review and the recommendations of the task force. Recommendations apply to typical surgical and obstetric patients. Infants, children, and special clinical settings (e.g., liver transplantation, sickle cell anemia) are beyond the scope of the report. Thus, the task force has not considered the transfusion of neonatal, infant, or pediatric patients or the recommendations on this topic that have been published by other groups. 12,13The recommended indications are based on scientific evidence and expert opinion regarding the effectiveness of the intervention. Effectiveness was judged by considering the potential clinical benefits, adverse effects, and costs of blood component therapy.Nonhemolytic transfusion reactions, often manifested in awake patients by fever, chills, or urticaria, are the most common adverse effects of RBC transfusion, but these signs may not be detectable during anesthesia. Nonhemolytic transfusion reactions occur in approximately 1–5% of all transfusions. 4Hemolytic reactions due to administration of incompatible blood can be life-threatening. The estimated risk of ABO-incompatible transfusion is 1:33,000 RBC transfusions. 14,15As with nonhemolytic reactions, general anesthesia may mask the symptoms of hemolytic reactions, and many of the signs (hypotension, tachycardia, hemoglobinuria and microvascular bleeding) may be attributed erroneously to other causes. The probability of a fatal hemolytic transfusion reaction is uncertain, with estimates ranging from 1:500,000 to 1:800,000. 15Between 1976 and 1985, the U.S. Food and Drug Administration was notified of 131 fatal ABO-incompatible transfusions. 16.The incidence of post-transfusion hepatitis, more than 90% of which is due to hepatitis C virus, has decreased since the introduction of testing for the virus in 1990. 17The reported incidence of hepatitis C virus seroconversion is 0.03% per unit transfused. 18However, the actual incidence is believed to be lower because of improved testing introduced in 1992. 19The risk of transmission of hepatitis B is estimated to be 1:200,000 units. 20.The risk of exposure to HIV through blood transfusion is uncertain. Although a range of incidence rates has been reported, 21–23recent estimates suggest that the mean infectious window period (the period between viral infection and its detection by tests for the presence of antibodies) is approximately 22 days 24and that the current risk of HIV infection in the United States is 1:450,000–1:660,000 per transfused unit of blood. 25Implementation of donor screening tests for HIV-1 antigen is expected to prevent up to 25% of the window period cases, or five to ten cases per year. 25Higher rates may occur in areas with increased HIV prevalence. 26.Perhaps the most common viral agent transmitted by blood transfusion is cytomegalovirus. Most infections are subclinical, although immunocompromised patients may develop severe morbidity. Parasitic and bacterial agents can be transmitted by blood components, but the incidence of clinically significant disease in the United States is low, possibly 1:1,000,000 units of blood. 27Twenty-six deaths due to bacterial contamination of blood components were reported to the Food and Drug Administration between 1976 and 1985. 16.Some studies suggest that patients with colorectal, breast, prostate, and certain other cancers may experience earlier recurrence and lower survival rates if they receive allogeneic (homologous) blood transfusions in the perioperative period, 28,29but other data challenge the association. 30Higher rates of postoperative infections have been reported in patients who received perioperative allogeneic transfusions than in those who were not transfused or who received only autologous blood. 31–34Other studies, however, have not confirmed this the costs of blood component therapy are are A study at one estimated that the for one unit of allogeneic was and that the and in the unit increased the to study at estimated that costs were per transfused unit of blood or RBCs, or per for all blood an estimated million units transfused each year in the United this to an of at with costs for all transfused estimates are of because they not include the of all blood components, and transfusion they not the benefits of transfusion therapy. the of blood component therapy be and the of improved transfusion in costs be 25% of the costs of RBC transfusions may be to transfusions. costs can be through the of more transfusion one was to transfusion costs by million by transfusion units of are transfused each year in the United States. most of these transfusions are for studies have rates of transfusions. rates of have been proper of RBC transfusion is the of The scientific for perioperative RBC transfusion on surgical patients experience adverse outcomes a of and RBC by can prevent these adverse outcomes. to these is reviewed oxygenation due to can have clinical because of effects on the and is the of and The is a of and the of in 1. Although an in is the for in the can at the tissue during of blood the can blood and to and the to to the and effects of be from those of although can with The clinical of are and a based on blood has been by the American College of of up to of total blood has other than and A of of blood and decreased patients may or A of signs of tachycardia, and patients has in of up to of blood can be with therapy. of more than of total blood is and by and and is lower of human to has not been is believed that is in most at tissue oxygenation is and at not a of is not to be at not occur the is than is through in in In patients with not the symptoms are the RBC is decreased by approximately has special for patients without significant adverse or A review of studies of obstetric patients no of on the incidence of or increased complications of with and of in suggest that is the is by more than a study of with than for decreased to the not in are because of in may be by however, and agents (e.g., or a for of is by certain and and by (e.g., have and that and and the to Most and decrease blood and and of these effects and a of In in effects on blood and they may in they the development of and in patients with or of is not in awake or those under general anesthesia. suggest that may lower and during anesthesia than may be due to an and of However, are no studies this The of anesthesia on is have been by clinical studies between and adverse perioperative or peripartum outcomes. of that patients than in the perioperative period without an in review of published between and 1990, on that of blood was the of in only patients and a to in an patients. review of of deaths due to all but of which at than of one of that was not a significant of it was than and blood be of literature however, in which are more to than The in most is to for regarding the to which to or regarding perioperative transfusion are often clinical is scientific for on a or a the that transfusion is in patients with a than or an than of blood are because of of blood during and the effects of therapy. Although often can be of due to the administration of and can or estimates of blood are from obtained at or and have been to the for RBC transfusion. (e.g., have not been and are of In the clinical setting, it is not to the of to or to these perioperative process regarding transfusion is by that is often and most in the postoperative period, is can at any during the postoperative period because of fever, or from the more potential benefits of RBC transfusion in improving other of have been effects on However, in is on and and not on blood transfusion of one unit of blood or the by approximately or the by in a studies have not been to the at which RBC transfusion clinical evidence that many RBC transfusions are because to blood not to be with increased perioperative or transfusions about by infections have not been with perioperative outcomes. most of these studies were and between perioperative and or has been A study of patients undergoing bypass that the incidence of postoperative and was the patients with than than patients with the group was and the results were not for that and the study not the effectiveness of RBC transfusions. A study of postoperative patients with than that RBC transfusions on with other studies of patients. of In the National Institutes of Health on Blood Transfusion that evidence not the use of a for transfusion, a than was evidence that to to perioperative morbidity. 1992, the recommended between and signs in to patients. The that patients with signs and no risk of or not RBC transfusion, of and recommended patients with signs only if risks of or were consensus convened by the College of Physicians of that RBC transfusion is only to the transfusion be by a of the overall of the patients be about RBC transfusion and available and the for transfusion be in the of Task The task force that any (e.g., an or an for the for perioperative or peripartum RBC transfusion. is an of The to on signs for patients. The to often is by the of surgical with and may be transfused more blood is (e.g., in signs often are by and other and are a of of the and other can occur in the presence of a of and with in only of patients and with blood in than of patients. the surgical to decreased and the that the to include the by the presence or of disease and and by and the and of blood and by and disease The task force its recommendations on available and evidence and expert The task force that transfusion is the is than and is it is than the is the of or RBC transfusion be based on the risk for complications of the use of a for all patients and other that to all and surgical oxygenation are not autologous blood and postoperative blood and to decrease blood and may be and the indications for transfusion of autologous may be more than for allogeneic because of the lower risks with the than units of are transfused each year in the United States. are in the perioperative and peripartum a or platelet is the of bleeding. The scientific on surgical patients experience adverse outcomes a of platelet and platelet transfusion can platelet and or prevent bleeding. to these with or platelet may experience and from severe surgical The platelet at which surgical and obstetric patients are to experience increased is In is with platelet than studies suggest rates in surgical patients with of and was not with increased in patients with platelet of clinical the of platelet in the of in surgical and obstetric but the probability of clinically significant in to the number of units of blood transfused. a study of transfused platelet than were in of patients who received or more units of and in no patients who received than units. of platelets, can to microvascular (e.g., from of is a during is evidence of complications from (e.g., in with is has no on the incidence of bleeding. is in approximately of with the liver and platelet with the is more but by the platelet (e.g., to may be more than platelet in a Although platelet studies may be in in surgical is a is in the The which platelet and the component of is by and and is to is that platelet transfusion can platelet The of is and is by the of from the and platelet Transfusion of one platelet the platelet by approximately in the The is one platelet per obtained by are the of approximately platelet transfused a period may and to platelet transfusion. In human or may be is evidence from settings regarding the effectiveness of in bleeding. of patients with platelet of or have that the incidence of can be decreased by platelet transfusions. studies in surgical patients are of platelet transfusion have not for patients undergoing transfusion. of In the National Institutes of Health on Transfusion Therapy recommended platelet transfusion for patients with platelet than that patients with platelet above were to that platelet transfusions at platelet may be for patients with or those at increased risk of because of or platelet 1994, the recommended platelet transfusion in patients with decreased platelet and platelet The recommended considering platelet transfusions in patients with platelet between and with they that transfusions may be at platelet to a than The recommended patients with platelet and platelet in the presence of microvascular bleeding. that platelet transfusion bypass in patients with and platelet guidelines may be for patients undergoing in because of about tissue from The platelet transfusion in certain patients with or of for and patients reported that transfusions were for patients with platelet of or for patients undergoing (e.g., the most was or of Task The task force that the for platelet transfusion is on risk and not a (e.g., platelet The risk in surgical and obstetric patients is by the and of the to the of the actual and of and the presence of that platelet (e.g., is scientific evidence to the platelet which the risk of surgical is recommendations of other groups (e.g., regarding platelet are based on evidence that may not be to all surgical patients. In the of the opinion of the task force is that platelet transfusion is in patients at platelet than recommended for patients because of the increased risk of complications due to in the surgical The task force that platelet are in patients who are transfused. platelet be obtained to the for platelet transfusion. In transfused patients with microvascular to be to platelet may from platelet The task force its recommendations on available and evidence and expert The task force that platelet transfusion is and is due to increased platelet (e.g., platelet transfusion is in surgical patients with due to decreased platelet the platelet is than and is the is The of patients with platelet therapy be based on the risk of surgical and obstetric patients with microvascular platelet transfusion if the platelet is than and therapy if it is than platelet the be based on the risk for more significant or with blood may be in patients with platelet than and platelet transfusion may be an platelet if is platelet and microvascular units of are transfused each year in the United States. significant of is transfused scientific for on the that patients are at risk of adverse effects from and transfusions can decrease those to these is reviewed that can be to perioperative due to is Blood are at of and are than of an blood the with approximately of the of and may be clinical from not occur one blood or the and a study of transfused and reported than in all patients who received or more units of and in of patients who received than units. a of patients who received for blood reported that and were increased in nine patients of one blood but that was no clinical evidence of bleeding. in patients with or than a study of patients who more than of blood during that patients with or than were more to have evidence of during surgery. or which in of the was not of due to which in only patients. of blood may be with a to microvascular bleeding. A study of transfused patients that approximately of was significant of or in were review of transfused patients that of during the with the of the of with the of the study of patients that of those with and and of those with and no a than and a than on in the received only therapy. the with no of studies that and are of surgical bleeding. and reported no cases of significant in on patients with liver disease and a than and reported that and were not with increased in patients with a or of up to no between and in patients undergoing liver reported no complications from in outcomes from these may not be relevant to the surgical of the is in with However, evidence of increased without clinically significant is in approximately of patients a is these not studies have been to perioperative administration of clinical Although reported of and with administration in patients transfused with no in was reported that of was to the to of in patients with liver disease and that the were possibly to and not to surgical review of patients coronary artery bypass and or an of units of not any in blood or transfusion patients with due to reported that improved administration in patients. studies in this group were transfusion to those of transfused patients undergoing the same with no evidence of of In 1985, the National Institutes of Health on that is for the that may occur in the perioperative or peripartum certain cases of transfusion, and (e.g., liver 1994, the recommended transfusions for the blood transfusion than one blood with of therapy, and a or clinical of an or or an The that the use of a or for was guidelines for transfusion have been issued by the the Committee for in the Committee that at units of in of Task The task force that clinical in the perioperative or peripartum in that of with FFP. The special clinical that in the include the of therapy and the of for which are the with microvascular is scientific evidence to suggest that studies obtained in the are in a that may to transfusion. Although blood can of the task force that a not occur more than of the blood has been The task force that is in patients with microvascular or who are transfused if the the and be obtained in a the task force that transfused patients with microvascular that is believed to be to may from The task force its recommendations on available and evidence and expert The task force the administration of with the for of for of for which are for of microvascular in the presence of or for of microvascular to in patients transfused with more than one blood and and be obtained in a be in to a of of plasma with administration of of for of for which of to five platelet one unit of platelets, or one unit of blood a of to that in one unit of for but of and in and is for of plasma or units of cryoprecipitate are transfused each year in the United States. which and is for the of and use in the is based on the that patients with these are at increased risk of and of is in these to these is reviewed is evidence from studies that patients with certain or (e.g., are at increased risk of perioperative or peripartum bleeding. unit of cryoprecipitate per plasma by approximately in the of or bleeding. studies have been to perioperative or peripartum administration of cryoprecipitate clinical evidence a for patients with and certain of most patients with are with and patients with of disease to administration of with can be with cryoprecipitate, but is the is with in which and increased are the most evidence that administration of cryoprecipitate in these settings the plasma The to with cryoprecipitate has been of In 1994, the recommended cryoprecipitate transfusions in patients with and patients with A is not recommendations have been issued by the Committee for in recommended the administration of cryoprecipitate for transfused patients with microvascular the is than of Task is scientific evidence regarding the effectiveness of cryoprecipitate in improving clinical and the task force that its perioperative and peripartum use be to on clinical the task force that cryoprecipitate is to be in patients with disease to and are The task force its recommendations on available evidence and expert The task force considering the administration of cryoprecipitate for in perioperative or peripartum patients with or disease to these be in with the patients with and of microvascular in transfused patients with than be measured in a to proper indications for blood component therapy is because of the potential adverse effects and costs of transfusion. These risks can be by other the most to minimize exposure to allogeneic blood through use of autologous transfusion and other blood but the of these complications of incompatible blood transfusions can be by and blood and transfusion and by a of for transfusion Most transfusion be based on and a comprehensive of the risk of comprehensive and transfusion have been with in blood component therapy. RBC use has been decreased by with and comprehensive have that transfusions can be by that include and the review of results with of practice and review by of transfusion results have been for platelet available evidence regarding the effectiveness of blood component therapy or The of data from studies with clinical and other of clinical effectiveness development of evidence-based clinical practice guidelines for blood component therapy. a scientific for transfusion is to evidence regarding the indications and effectiveness of blood component therapy. these data guidelines for blood component therapy are to