Preoperative Autologous Blood Donation
Acute Normovolemic Hemodilution
Transfusion of Autologous Blood Components Unused Autologous Blood - Why Is It Not Made Available for General Use? INTRODUCTION Autologous Blood transfusion is the collection and re-infusion of the patient's own Blood or Blood components. Allogeneic Blood, on the other hand, is collected from someone other than the patient. Over the last several years, an increased awareness of diseases transmitted by allogeneic Blood has resulted in a dramatic increase in autologous Blood transfusion. Approximately 16 million units are donated annually, and of those, about 643,000 are autologous. This number of autologous donations is growing each year. Clinical research and practice in autologous Blood use have also grown in recent years, providing new insights into the issues involved. The new insights are to be found most often at the National Heart, Lung, and Blood Institute's recommendations on the use of autologous Blood.1 Despite reduction of the risk of transmitting viruses such as the human immunodeficiency virus (HIV) or hepatitis B or C (HCV), autologous Blood transfusion remains safer than allogeneic Blood transfusion and appropriate for properly selected patients. Exclusive or supplemental use of autologous Blood can eliminate or reduce many adverse effects of transfusion. Directed donations, that is Blood donated by a friend or family member for a designated patient, are not as safe as the patient's own Blood and must not be considered equivalent to autologous donations. Since most planned surgical procedures are not associated with sufficient Blood loss to result in transfusion, autologous Blood techniques are not appropriate for all patients. The transfusion experience of patients who have undergone similar procedures can serve as a guide. If transfusion is likely for a planned surgical procedure, several types of autologous transfusion can be used either alone or in combination:
Standards, guidelines, and regulations exist for patient selection as well as processing and transfusion of Blood collected using autologous transfusion techniques.4-8 These should be used by each hospital's transfusion committee in establishing and monitoring autologous transfusion programs. Table I below, summarizes the accepted proper uses of autologous transfusion techniques for selected surgical procedures. Autologous techniques are considered inappropriate for many surgical procedures because the expected Blood loss is small and it is unlikely the patient will receive a transfusion. The best approach depends, in part, upon the surgical procedure planned. For example, PABD and postoperative Blood salvage are appropriate for patients undergoing revisions of total hip replacement, a procedure that frequently necessitates transfusions. However, intraoperative Blood loss for total knee replacement is minimal because tourniquets are used. Thus intraoperative Blood salvage would not be effective.
PREOPERATIVE AUTOLOGOUS BLOOD DONATION In general, autologous Blood donations are indicated for patients having surgical procedures for which Blood could be needed, and for which Blood is likely to be cross-matched. Tables for the amount of Blood to be cross-matched for specific procedures are widely available in hospitals9 and may serve as guides for the amount of autologous Blood that should be collected.10 The less likely the possibility of transfusion, the more likely the donated Blood will not be used. Therefore, potential surgical patients should not be encouraged to donate autologous Blood for surgery unless there is a realistic possibility of transfusion, for example, the likelihood of transfusion is greater than 10%. Surgical Procedures For surgical procedures where transfusion is likely, autologous donations can provide some or all of the Blood components needed by the patient (see Table I). Nevertheless, PABD does not completely eliminate the possibility that the patient might receive allogeneic Blood. If the need for transfusion is greater than anticipated, or insufficient autologous Blood has been collected, the patient may need Blood from the allogeneic supply. Thus, during the discussion with the patient of the surgical risks and benefits, autologous donations cannot be presented as a guarantee against allogeneic transfusions. The indications for PABD may be broadened and the number of units to be collected increased under unusual circumstances (e.g., patients with coagulation disorders that increase the risk of bleeding, or patients with alloantibodies for whom locating compatible Blood may be difficult). Selection of Patients Most patients who are healthy enough to undergo elective surgery will be able to donate Blood preoperatively. Determination of suitability for PABD is the responsibility of the physicians caring for the patient and the physician responsible for the Blood collections. In deciding to collect autologous Blood from a patient, the benefit of decreased exposure to allogeneic Blood must be weighed against the risk of making the donation and of delaying surgery for the time needed for adequate regeneration of red Blood cells (RBCs). Appropriate patients are those having:
Patients with conditions predisposing to bacteremia, such as those with an indwelling urinary catheter or a device penetrating the skin, are not eligible for PABD because bacteria collected with the Blood may proliferate during its storage. Vasovagal reactions occur in about 2% to 5% of all Blood donors--either autologous or allogeneic. Most vasovagal reactions consist of lightheadedness due to transient hypotension and bradycardia and are self-limited. Severe reactions with loss of consciousness or seizure activity are uncommon.11,12 According to information from the American Red Cross, autologous Blood collections result in hospitalization of approximately 1 donor in 16,000 autologous collections per year (written communication, N. Rebecca Haley, M.D., May 1994). Special Considerations Special consideration should be given to the following situations:
Technique The decision to collect PABD should be based on a discussion between doctor and patient regarding the procedure's risks and benefits, after which the patient can be referred to a Blood collection facility. Here, the patient is evaluated for eligibility of autologous donation. Patients distant from the hospital where surgery is planned often can donate at a local Blood collection facility and have the Blood sent to the hospital. Many patients can give Blood as frequently as every 3 days, although once a week is more common. Patients donating autologous Blood may benefit from oral iron supplementation; for example, ferrous sulfate 325 mg P.O. T.I.D. or ferrous gluconate 325 mg five times a day. The optimal donation period begins 4 to 6 weeks before surgery in order for a sufficient number of units to be donated and to enable more complete RBC regeneration. In any case, the last Blood donation should not be collected later than 72 hours before surgery to allow for restoration of intravascular volume.4 A single unit donation a few days before surgery will not be beneficial because minimal RBC regeneration will occur. Handling and Storage Autologous Blood components require special handling and segregated processing and storage compared with allogeneic units. In addition, increased personnel time is associated with collecting Blood from patients with complex medical histories as opposed to healthy donors. Therefore, autologous Blood often costs more than allogeneic Blood and may result in billing surcharges. If a unit of autologous Blood is confirmed to be anti-HIV or HBsAg-positive, the Food and Drug Administration (FDA) recommends that it be discarded.7 However, the donor may be transfused with these autologous components if permitted by the hospital and collecting facility and if appropriate documentation is provided by the patient's physician. The patient's physician should be informed if tests on a unit are positive for anti-HCV, anti-HBc, or syphilis.4
Release of Unused Autologous Units Unused autologous Blood is stored for the patient's perioperative needs for a variable period of time after the operation (in accordance with local policies and procedures). Typically, this Blood is stored until the patient's discharge or the unit's outdate. If a second surgical procedure is anticipated or if the scheduled procedure is delayed, the transfusion service may be able to arrange for extended frozen storage of the autologous Blood. Unused autologous Blood is usually destroyed rather than being added to the allogeneic Blood inventory. Only a relatively small number of autologous units are suitable for transfusion to other patients because autologous donors often do not meet the health criteria required for allogeneic Blood donors. Furthermore, the suitable unit, when no longer needed by the donor, often has a very short shelf life. Thus, the adding of unused autologous Blood to the inventory would have little impact on the overall Blood supply and should not be considered a justification for requesting autologous donations from patients who are not likely to require transfusion. Additional Autologous Components
Risks Despite the use of special systems to avoid administering the wrong unit of allo-geneic or autologous Blood to patients, such errors happen. The dependency of preoperative Blood donation and transfusion on clerical accuracy has resulted in increased vigilance. Nevertheless, the likelihood that autologous Blood is given to the wrong patient is not zero but can be estimated to be 1:30,000 to 1:50,000.34,35 The Role of Recombinant Erythropoietin in PABD Several studies have demonstrated that administering recombinant erythropoietin (rEPO) can increase the amount of autologous Blood that can be collected over a given period of time.36,37 Although rEPO increases erythropoiesis, its role in PABD is limited to a few situations, such as when a patient is already anemic or needs to donate an unusually large amount of Blood in a short time.38 The FDA has not approved the use of rEPO for autologous donation. Perioperative Blood salvage is the collection and reinfusion of Blood lost during and immediately after surgery. Once used almost exclusively during cardiac procedures, perioperative Blood salvage is now commonly used for vascular and orthopedic surgical operations, some solid organ transplants, and some trauma cases. See Table I for selected procedures where perioperative salvage may be appropriate, as well as examples where intraoperative salvage is usually unnecessary. INTRAOPERATIVE BLOOD SALVAGEThe amount of RBCs recovered during surgery varies with the procedure but may amount to 50% or more of that lost. Even though the amount recovered may be equivalent to only one or two units of Blood for some patients, this may be of significant benefit, especially when combined with other autologous transfusion techniques. The posttransfusion survival of intraoperatively recovered RBCs is comparable to that of allogeneic RBCs.39,40 Surgical Procedures In general, intraoperative Blood salvage is appropriate for the following surgical procedures:
Selection of Patients Many surgical patients who undergo procedures in which transfusions are likely can benefit from intraoperative Blood salvage, especially in cases where preoperative donation is impossible or inadequate.42 If the shed Blood is collected by sterile methods and properly reinfused, the procedure has few risks. Relative contraindications to the use of intraoperative Blood salvage include:
Technique Blood salvaged intraoperatively may be transfused directly after collection or processed (washed) prior to infusion. Controversy exists regarding the relative merits of washed versus unwashed salvaged Blood.51,52 Washed Blood has the theoretical advantage of reducing infusion of free hemoglobin, tissue procoagulants, and debris. Although data regarding the safety of unwashed salvaged Blood are limited, this form of autologous Blood is usually infused in relatively small amounts (<2 L) without significant adverse effects.53 When collecting Blood for infusion without processing, care should be taken to avoid hemolysis (due to high aspiration pressure and surface suctioning) and contamination with tissue debris. Because of the presence of debris and the high incidence of hemolysis, washing salvaged Blood during orthopedic procedures is indicated. Commercially available equipment with disposable software exist for each option:
To ensure a quality Blood product for re-infusion, a well designed program and appropriately trained staff are necessary. The American Association of Blood Banks has developed guidelines and standards that are valuable in designing an effective intraoperative recovery program and maintaining quality assurance.53 POSTOPERATIVE BLOOD SALVAGESurgical Procedures Postoperative Blood salvage is used most frequently for cardiac and orthopedic surgical patients.
Technique Blood salvaged postoperatively generally is collected from mediastinal, chest, and joint drains and transfused without washing. Because it is defibrinogenated, it does not require anticoagulation prior to transfusion. Although diluted, the Blood is sterile and has viable RBCs.64 TRAUMATIC HEMOTHORAXBlood that collects in the thoracic cavity following blunt or penetrating trauma is analogous to Blood shed following cardiac or orthopedic surgery. It is defibrinogenated and may be collected and transfused. Typically, this process is accomplished using chest drainage devices that have been adapted for Blood salvage.65 RISKS OF PERIOPERATIVE BLOOD SALVAGE
ACUTE NORMOVOLEMIC HEMODILUTION Acute normovolemic hemodilution (ANH) is the removal of Blood with the simultaneous infusion of cell-free solution(s) to maintain intravascular volume prior to surgical Blood loss.70 Hemodilution is a transfusion option for patients who will tolerate a large, acute decrease in hemoglobin concentration. ANH reduces RBC loss because the Blood lost during surgery has a lower hematocrit. The removed Blood is reinfused during or after surgery, as needed, to maintain the desired post-ANH hemoglobin concentration. ANH requires vigilance, clinical expertise, and an understanding of the physiological consequences. Efficacy Mathematical analysis predicts that the efficacy of ANH increases with greater surgical Blood loss, higher initial patient hematocrit, and lower post-ANH hematocrit. In addition, mathematical analysis predicts that extreme hemodilution (for example, reduction to hematocrit 0.20), may result in substantial reduction of allogeneic Blood transfusions if surgical Blood loss is > 50% of Blood volume.71 Removal of several units of Blood in patients with Blood loss of < 50% of Blood volume may have little or no effect on the requirement for allo-geneic transfusion.72 Randomized studies show conflicting results regarding the efficacy of ANH, perhaps due to the varying conditions of each study.73-75 Further clinical studies are needed to test the models and determine the extent of efficacy. Surgical Procedures Table I lists examples of surgical procedures in which expected Blood loss may be substantial and ANH may be appropriate, as well as examples of surgical procedures in which expected Blood loss usually is not sufficient to warrant ANH. Selection of Patients ANH may be employed alone or in conjunction with other forms of autologous transfusion. Although PABD may be inadvisable for some patients with serious cardiac disease, withdrawing Blood in the operating room under carefully controlled and monitored conditions offers an alternative for many of these patients. When PABD is undesirable or impossible (e.g., there is a potential for bacteremia or too little time for donation), ANH may be an appropriate solution. ANH can also be considered when malignancy or infection at the operative site precludes the use of intraoperative Blood salvage. Since ANH probably is efficacious only when the hematocrit is reduced to < 0.30, additional caution is necessary in patients with hepatic dysfunction or cardiovascular, cerebrovascular, or pulmonary disease. Technique The amount of Blood removed depends on the patient's Blood volume and the initial and post-ANH hematocrits.76,77 The Blood must be collected into properly labeled Blood bags containing an anticoagulant. It may be stored at room temperature (to preserve platelet function) for up to 8 hours and up to 24 hours if appropriately refrigerated.4 The hematocrits of the units will vary between the initial hematocrit and the post-ANH hematocrit. Risks
TRANSFUSION OF AUTOLOGOUS BLOOD COMPONENTS When should Blood (autologous or allogeneic) be transfused? Blood components should be transfused only when they are needed. However, objective indications for the transfusion of Blood components are difficult to establish. The decision to transfuse RBC's is ideally based on the prevention of tissue hypoxia due to an oxygen transport deficit. No specific method to measure or anticipate a clinically significant deficit exists. In awake patients, symptoms of oxygen deficiency such as headache, lightheadedness, tinnitus, and faintness are nonspecific and do not lend themselves to the avoidance of symptomatic hypoxia. If available, base excess, the oxygen extraction ratio, serum lactate, and cardiac index can be used as surrogate markers. The hemoglobin and hematocrit are easily obtained laboratory values, but are far less likely to reflect the degree of oxygen deficiency in a patient because many other factors affect oxygen transport, such as underlying cardiac or pulmonary disease, cardiac output, and hemoglobin's affinity for oxygen. Practice guidelines have been based on hemoglobin levels, although the inadequacy of this approach is widely recognized.78 In general, transfusions at or below hemoglobin levels of 70 g/L (hematocrit 0.21) are appropriate, whereas transfusions at hemoglobin levels above 100 g/L (hematocrit 0.30) rarely are indicated. Between these two levels, clinical circumstances such as the potential for further Blood loss and the patient's underlying condition will determine the decision to transfuse. Should the indications for autologous Blood transfusion differ from those for allogeneic Blood transfusion? The comparative indications for the use of autologous or allogeneic Blood are controversial. If precise indications for a Blood transfusion could be defined, autologous Blood could be used only in situations where allogeneic Blood would be given.79 On the other hand, the benefits of allogeneic and autologous RBC transfusions are similar, but the risks of autologous Blood are less. Hence, the risk-benefit ratio supports the more liberal use of autologous Blood.80,81 Although some physicians may choose to use autologous Blood components more liberally than allogeneic components for a given indication, autologous Blood should not be transfused merely because it has been collected. For example, the transfusion of autologous RBCs to the slightly or non-anemic patient or the use of autologous fresh frozen plasma in the absence of coagulopathy is inappropriate. In what order should autologous RBC's be transfused when a variety of autologous components are available? When multiple autologous RBC components are available, the decision to transfuse should be based on a variety of factors, such as the component's quality, safety, efficacy, and shelf life. Table II lists the shelf life of autologous RBCs.
Why is Autologous donated Blood not made available for general use? 1. Liberal eligibility criteria to maximize patient participation In order to enable as many patients as possible to donate Blood for their planned surgery we deliberately relax the medical eligibility criteria. For example, we lower the acceptable hemoglobin/hematocrit level and accept persons with serious medical conditions (e.g., cancer and heart disease) that would ordinarily disqualify them from donating for general use. 2. Unexpected conditions diagnosed after surgery (e.g., cancer) may render a donation unsuitable, requiring a recall In this situation, if the unit had been designated for general use and transfused to another person, an FDA-mandated recall would have to be initiated. Because Blood banks would then have to notify recipients of recalled units and their physicians, and considerable expense and anxiety would result, we feel it best to have a single uniform set of criteria for donors of Blood intended for general use. 3. Since most autologous donations are unsuitable for general use, any savings from releasing these donations for general use would be outweighed by the administrative costs of subjecting the donors to a full medical history. In view of this, and because these patients are usually making repeated donations over a short time, we limit the medical history to those questions addressing the safety of the donor. This reduces the time patients must take to make their donations. 4. Safety Concerns: Some patients, fearful that mention of certain information may disqualify them from donating for themselves, may not fully disclose their medical history, thus increasing the possibility their Blood could transmit an infection to others. Studies of the incidence of positive test results for infectious agents show higher rates among autologous donors than volunteer donors. Since a negative test result may occur in the presence of infection (= "false-negative"), this higher incidence of positive test results suggests that their Blood may be less safe than that of volunteer donors. If autologous Blood were made available for general use, hospitals would have to maintain two inventories of this Blood. This increases the possibility for erroneous release, with an unsuitable autologous unit being transfused to another person. 5. Legal liability Excluding unused autologous donations from general use has become the standard of care throughout the United States. If a "crossed over" autologous unit led to disease transmission, legal liability for the hospital and the physician could be considerable. The American Medical Association and the American Association of Blood Banks have adopted a binding policy discouraging the "crossover" of unused autologous Blood units to the allogeneic volunteer Blood supply.
Options for using autologous Blood for planned surgical procedures include: (1) preoperative autologous Blood donation (PABD), 2) intraoperative Blood salvage, (3) postoperative Blood salvage, and (4) acute normovolemic hemodilution (ANH). The use of autologous techniques can decrease or eliminate exposure of patients to allogeneic Blood. Although currently the risks of adverse events related to transfusion with allogeneic Blood are low, autologous transfusion remains the safest option. Autologous Blood transfusion techniques should be used for eligible patients likely to require transfusion but should not be started for procedures in which transfusion is unlikely. An effective preoperative autologous donation program depends on cooperation among the patient, doctor, and Blood collection facility. The physician must weigh the expected risks and benefits of autologous Blood use for each patient prior to requesting PABD, perioperative Blood salvage, and/or ANH and prior to reinfusing the Blood. With individualized and careful planning, problems of insufficient autologous donations, unnecessary donations or Blood salvage procedures, and unnecessary transfusions may be avoided. An organized "team approach" is needed to select the appropriate equipment and ensure safe transfusion practice. For further information on autologous Blood trans-fusion, contact:
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Appl Cardiopul Pathophysiol. 1993;5:4-8. 69. Aaron RK, Beazley RM, Riggle GC. Hematologic integrity after intraoperative allotransfusion. Comparison with bank Blood. Arch Surg. 1974;108:831-837. 70. Stehling L, Zauder HL. Acute normovolemic hemodilution. Transfusion. 1991;31:857-868. 71. Weiskopf RB. Mathematical analysis of isovolemic hemodilution indicates it can decrease need for allogenic transfusion. Transfusion. In press. 72. Brecher ME, Rosenfeld M. Mathematical and computer modeling of acute normovolemic hemodilution. Transfusion. 1994;34:176-179. 73. Lorentz A, Osswald PM, Schilling M, Jani L. A comparison of autologous transfusion procedures in hip surgery. Anaesthesist. 1991;40:204-213. 74. Ness PM, Bourke DL, Walsh PC. A randomized trial of perioperative hemodilution versus transfusion of preoperatively deposited autologous Blood in elective surgery. Transfusion. 1992;31:226-230. 75. Rose D, Coutsoftides T. Intraoperative normovolemic hemodilution. J Surg Res. 1981;31:374-381. 76. Bourke DL, Smith TC. Estimating allowable hemodilution. Anesthesiology. 1974;41:609-612. 77. Gross JB. Estimating allowable Blood loss: corrected for dilution. Anesthesiology. 1983;58;277-280. 78. Office of Medical Applications of Research. National Institutes of Health. Perioperative red Blood cell transfusion. JAMA. 1988;260:2700-2703. 79. Gould SA. Should the same indications be used for allogeneic and autologous Blood? The autologous dilemma. Transfusion. In press. 80. Miller RD, von Ehrenburg W. Should indications for autologous and homologous transfusion be the same? Transfusion. In press. 81. Neuwirth BR, White RP Jr, Collins ML, Phillips C. Recovery following orthognathic surgery and autologous Blood transfusion. Int J Adult Orthodon Orthognath Surg. 1992;7:221-228. NOTE: The above document is based on materials provided by The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health, an agency of the U. S. 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