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PubMed2006

Balancing evidence and public opinion in health technology assessments: the case of leukoreduction.

Leukoreduction, filtering white blood cells from transfusion blood, effectively avoids leukocyte-related complications of blood transfusion. The technology has proven its relative cost-effectiveness for specific patient populations. With the advent of variant Creutzfeldt-Jakob disease, a transmittable spongiform encephalopathy caused by mad cow disease (bovine spongiform encephalopathy), the hard hit United Kingdom introduced universal leukoreduction for all patients as a precaution for transmission of prions in 1999. This costly policy was followed by many other countries, in the absence of much evidence of an actual health problem or of a more than presumed effectiveness of leukoreduction in preventing prion transmission. The core problem proved to be legal. The blood banks are legally accountable for blood safety. This accountability is absolute, based on avoidance of all possible risks, regardless of costs. This strategy leads to inefficiencies in health care: (i) blood safety management is guided by available rather than cost-effective technology, and (ii) private insurance premiums for civil liability are sharply increasing, while they are in no way related to the expected returns and the high and increasing blood safety. A rational safety policy is to be optimal, taking into account costs and effects of the safety procedures. This issue will need an open discussion with the general public of the real risks and a clear and unambiguous definition of proportionality in the precautionary principle, based on the European law.

Blood Banks↗
PubMed1998

The annual cost of blood transfusions in the United Kingdom.

This study estimated the annual cost of blood transfusions in the UK during 1994/1995. The analysis was based on published data, information derived from interviews with relevant NHS personnel and a purpose-designed structured questionnaire of blood donors. The cost to the UKs blood transfusion services of providing blood and blood products for transfusion was 165.5 Pounds million in 1994/1995. During this period, 2.75 million conventional donations of whole blood and 144,000 apheresis donations of platelets and plasma were collected: 2.58 million units of red blood cells were issued, resulting in approximately 866,000 red blood cell transfusions; 334,000 units of fresh frozen plasma and 1.16 million units of platelets were issued, resulting in approximately 17,000 and 188,000 isolated plasma and platelet transfusions, respectively. Hospital resource use attributable to providing blood transfusions during 1994/1995 cost the NHS 52.6 Pounds million. In total, blood transfusions cost the NHS 218.2 Pounds million during 1994/1995. Of this, red blood cell transfusions accounted for 76% of the annual cost, isolated platelet transfusions 16%, isolated plasma transfusions 1% and other products 7%. Donors incurred direct costs of 3.1 Pounds million and indirect costs of 11.2 Pounds million were accrued due to lost productivity. Additionally, blood donors gave up 2.5 million hours of their leisure time donating blood.

Absenteeism↗
PubMed1998

Transfusion of white-cell containing allogeneic blood components and postoperative wound infection: effect of confounding factors.

Randomized controlled trials (RCTs) of the relationship between allogeneic transfusion and post-operative bacterial infection at any site have generated discordant results, but have suggested an association of transfusion with wound infection. To examine the specific association of perioperative transfusion with wound infection, we reviewed the records of 964 consecutive patients undergoing elective colorectal cancer resection at our hospital. Diagnoses of wound infection were made retrospectively by the Centers for Disease Control criteria, and transfusion was defined as number of units of white-cell containing allogeneic blood components received. The probability of wound infection in association with the transfusion was calculated following adjustment for the effects of 12 confounders that had not been previously considered in combination. These factors related to severity of illness, difficulty of operation and risk of wound infection. Wound infection developed in 39 (11.4%) transfused patients, as compared to 24 (3.9%) untransfused subjects (P < 0.0001). In the multivariate analysis, there was a trend suggesting an adverse transfusion effect, which amounted to a 7% increase in the risk of wound infection per unit of red cells or platelets transfused (relative risk [RR] = 1.07; 95% confidence interval for RR = 0.98-1.16; P = 0.1241). This marginally significant effect was related to post-operative (P = 0.1274), rather than perioperative (P = 0.3061), transfusion. We conclude that allogeneic transfusion may perhaps be associated with a small increase in the risk of post-operative wound infection, but this small effect can be established only by RCTs enrolling several thousand patients. The modest magnitude of the effect may have been responsible for the disagreements among the published RCTs.

Aged↗
PubMed2003

The annual cost of blood transfusions in the UK.

This study estimated the annual UK cost of blood transfusions in 2000/2001, updating a study we performed in 1994/1995. The analysis was based on published data, information from interviews with National Health Service (NHS) personnel and a structured questionnaire for blood donors. The annual cost of provision and transfusion of blood products increased by 256% in real terms, to pounds 898 million in 2000/2001, whereas the number of whole-blood donations increased by 2% to 2.8 million. The number of apheresis donations decreased by 52% to 70 000. Total blood product units issued to hospitals in 2000/2001 increased by 17% and were used in an estimated 1.7 million transfusions. The estimated NHS cost for an adult transfusion was pounds 635 for red blood cells, pounds 378 for fresh frozen plasma, pounds 347 for platelets and pounds 834 for cryoprecipitate. Blood donors incurred an annual direct cost of pounds 8.1 million and 3.1 million hours of used leisure time. There was also an indirect cost of pounds 7.2 million arising from lost productivity. The large increases since 1994/1995 reflect a real increase in expenditure by the blood transfusion services, partly due to the introduction of leucodepletion, greater hospital resource use due to more transfusions being undertaken and under-recording of hospital activity in 1994/1995.

Absenteeism↗
PubMed2003

Automated collection of blood components: their storage and transfusion.

The performance of an automated device, the Gambro TRIMA, was evaluated for component production, and an in vivo assessment of the platelets was carried out. Red cell concentrates (RCCs), platelets and plasma were collected and stored according to standard blood bank procedures and evaluated for quality by in vitro measurements. Additionally, single-donor platelets (n=10) were transfused to thrombocytopenic patients after 5 days of storage. Platelet counts were measured after 1 h and the corrected count increment (CCI) was calculated. No significant changes were seen before or after procedure in donor haemoglobin, haematocrit, coagulation factors or platelet count. Return-line samples showed no increase in the level of plasma haemoglobin. Plasma haemoglobin and potassium increased following RBC storage, but there was no change in the red cell number. Platelet aggregation decreased from 52 to 11% (adenosine diphosphate) and the Kunicki morphology score dropped from 379 to 174. Little change was seen in the hypotonic shock response (69-63%) or in the percentage of CD62 expression (4.8-19.8) over time. The CCI averaged 28+/-26 x 10(3) microL(-1) in 10 patients 1 h after transfusion. The TRIMA machine collects RCCs, platelets and plasma in a variety of combinations in one session. For autologous collection, two units of RCC plus platelets can be collected at one time, reducing administrative and testing costs. The platelets have good in vivo recovery, as shown by the CCI values. An added advantage is that the TRIMA machine can be used in hospitals to generate components in times of shortage without the need for a component's laboratory.

Automation↗
PubMed1993

Blood donor-, apheresis-, and transfusion-related activities: results of the 1991 American Association of Blood Banks Institutional Membership Questionnaire.

Approximately 2154 regional blood centers and hospital-based blood banks and transfusion services responded to the 1991 American Association of Blood Banks Institutional Membership Questionnaire that elicited data from 1990. Information from 2144 institutions was considered valid. Questionnaire topics were donor blood collections, hemapheresis, perioperative cell salvage, component usage, and transfusion-associated diseases. Institutional members reported collecting 9.3 million units, of which 90.9 percent were for allogeneic use in the community, 6.0 percent were for autologous use, and 3.1 percent were directed donations. The percentage of directed-donor units that were crossed over for allogeneic use (51%) was greater than the percentage of units transfused to the designated patient (49%). Only 12.5 percent of institutions reported obtaining specific consent for transfusion. Of the 15.4 million transfused blood components, 8.5 million were red cells, 4.1 million were platelets, 1.8 million were fresh-frozen plasma, and 0.9 million were cryoprecipitate. There were 1263 reported cases of transfusion-associated hepatitis. Approximately 44 percent of the patients who were tested proved positive for hepatitis B surface antigen, and 80 percent of the patients who were tested proved positive for antibody to hepatitis C. The questionnaire's aggregate results can be used to assess current patterns of blood donation and transfusion activities.

Acquired Immunodeficiency Syndrome↗
PubMed1995

A comprehensive transfusion medicine curriculum for medical students. Transfusion Medicine Academic Award Group.

BACKGROUND: The Transfusion Medicine Academic Awards (TMAA) program, sponsored by the National Heart, Lung, and Blood Institute, has provided grants to medical schools to help them develop comprehensive curricula in transfusion medicine. In 1989, the TMAA Group published a set of comprehensive curricular goals for teaching transfusion medicine. The medical student portion of this curriculum has now been revised to reflect new developments in transfusion medicine and recent trends in medical school education. STUDY DESIGN AND METHODS: Two medical schools independently revised the 1989 curriculum for their students. Because significant similarities were noted between curricula of the two institutions, the two revisions were combined and submitted to all TMAA institutions for comment. As a result, a revised medical school curriculum was developed and approved by the TMAA Group. RESULTS: The revised curriculum consists of 28 objectives in six major areas of transfusion medicine. It is presented in its entirety in this article. CONCLUSION: The TMAA transfusion medicine curriculum should provide to medical schools a valuable resource for evaluating their teaching of transfusion medicine and should provide to medical school deans and curriculum committees an authoritative source of transfusion medicine expertise.

Autoimmunity↗
PubMed1996

Institutional variation in hemotherapy for solid organ transplantation.

BACKGROUND: Solid organ allograft recipients may require large amounts of blood components. The modification of components to make them safer for iatrogenically immunosuppressed transplant patients increases workload demands on blood banks and transfusion services. STUDY DESIGN AND METHODS: Institutions within the United States and Canada providing hemotherapy as support for transplant recipients were surveyed for their transfusion practices. RESULTS: Responses from 25 institutions provide the data for this report. In 1991, the mean intraoperative red cell requirements ranged from <1 unit for renal allograft recipients to 17.3 units for liver transplant recipients. The latter group also required the greatest amounts of platelets, fresh-frozen plasma, and cryoprecipitate. More than 75 percent of responding institutions provided either cytomegalovirus-seronegative or white cell-reduced cellular components to pediatric recipients of liver allografts and to both adult and pediatric recipients of heart, lung, and heart-lung allografts. The use of irradiated cellular blood components, although uncommon, was greatest in heart transplant recipients. The use of pretransplantation transfusions for immunomodulation was generally limited to patients awaiting a living-donor renal transplant. CONCLUSION: Transfusion practices varied among the institutions, but the majority provide cytomegalovirus-safe cellular blood components to heart and lung allograft recipients and to pediatric transplant patients. Gamma-radiated cellular components are not routinely provided to patients undergoing solid organ transplantation. Liver allograft recipients require the greatest amount of hemotherapeutic support.

Adult↗
PubMed1998

Granulocyte collection efficiency and yield are enhanced by the use of a higher interface offset during apheresis of donors given granulocyte-colony-stimulating factor.

BACKGROUND: Trials evaluating granulocyte transfusions for therapy of febrile neutropenia demonstrated mixed clinical results, which may in part be due to the low neutrophil cell dose of the transfused components. To optimize the latter variable, the effect of various interface offset (IO) settings during apheresis on granulocyte collection efficiency (GCE) and yield was determined in normal donors given granulocyte-colony-stimulating factor (G-CSF). STUDY DESIGN AND METHODS: Seventeen donors underwent 44 granulocyte collections performed with a continuous-flow blood cell separator with hetastarch infusion after stimulation with G-CSF (5 micrograms/kg/day). Apheresis was performed alternatively using one of three IO settings: IO = 15 (Group 1, n = 16), IO = 25 (Group 2, n = 12), and IO = 35 (Group 3, n = 13). The GCE and yield and changes in donor platelet count, hematocrit (Hct), and red cell (RBC) volume of the components were compared among the three groups. RESULTS: The mean GCE was greater (p = 0.006) during apheresis at an IO setting of 35 (60 +/- 12%) than at an IO setting of 15 (40 +/- 17%). The mean granulocyte yield (x10(10) per procedure was 10.8 +/- 2.95 at an IO setting of 35 and 7.73 +/- 4.02 at an IO setting of 15 (p = 0.08). In a multivariate linear regression model, factors independently associated with granulocyte yield were the absolute granulocyte count (r = 0.73, p < 0.001) and blood volume of the donor (r = 0.54, p = 0.001) before the procedure and the use of an IO setting of 35 (r = 0.50, p = 0.002). There was no significant difference among the three groups in the decrement in donor platelet count or Hct with apheresis, although the mean RBC volume was greater in Group 3. CONCLUSION: Granulocyte apheresis at an IO setting of 35 rather than 15 resulted in a significant increase in the GCE. The use of an IO setting of 35 during apheresis was an independent factor associated with granulocyte yield in the multivariate model. Donor safety was not compromised by collecting granulocytes at the higher IO setting.

Adult↗
PubMed1998

The distribution of infectivity in blood components and plasma derivatives in experimental models of transmissible spongiform encephalopathy.

BACKGROUND: The administration of blood components from donors who subsequently develop Creutzfeldt-Jakob disease has raised the issue of blood as a possible vehicle for iatrogenic disease. STUDY DESIGN AND METHODS: We examined infectivity in blood components and Cohn plasma fractions in normal human blood that had been "spiked" with trypsinized cells from a scrapie-infected hamster brain, and in blood of clinically ill mice that had been inoculated with a mouse-adapted strain of human transmissible spongiform encephalopathy. Infectivity was assayed by intracerebral inoculation of the blood specimens into healthy animals. RESULTS: Most of the infectivity in spiked human blood was associated with cellular blood components; the smaller amount present in plasma, when fractionated, was found mainly in cryoprecipitate (the source of factor VIII) and fraction I+II+III (the source of fibrinogen and immunoglobulin); almost none was recovered in fraction IV (the source of vitamin-K-dependent proteins) and fraction V (the source of albumin). Mice infected with the human strain of spongiform encephalopathy had very low levels of endogenous infectivity in buffy coat, plasma, cryoprecipitate, and fraction I+II+III, and no detectable infectivity in fractions IV or V. CONCLUSION: Convergent results from exogenous spiking and endogenous infectivity experiments, in which decreasing levels of infectivity occurred in cellular blood components, plasma, and plasma fractions, suggest a potential but minimal risk of acquiring Creutzfeldt-Jakob disease from the administration of human plasma protein concentrates.

Animals↗
PubMed1999

Frequency of immediate adverse effects associated with therapeutic apheresis.

BACKGROUND: Therapeutic apheresis was found to be reasonably safe in prior studies using instruments that are now largely obsolete. The incidence of adverse effects with current instruments and techniques has not been assessed in a large multicenter study. STUDY DESIGN AND METHODS: A survey was conducted in 1995 using a uniform questionnaire that asked about 32 specific events but excluded transient paresthesia and mild vasovagal events. Eighteen centers returned 3429 responses concerning 125 to 500 therapeutic apheresis procedures per center. RESULTS: Two hundred forty-two adverse events were reported in 163 procedures (4.75% of all procedures; 6.87% of first-time procedures and 4.28% of repeat procedures). The numbers (incidence) of selected specific events were transfusion reaction, 56 (51 in plasma exchange [PE] with plasma replacement) (1.6%); citrate-related nausea and/or vomiting, 41 (1.2%); systolic blood pressure <80 mmHg, 34 (1.0%); vasovagal nausea and/or vomiting, 17 (0.5%); pallor and/or diaphoresis, 16 (0.5%); pulse >120, 14 (0.4%); respiratory distress, 9 (0.3%); tetany or seizure, 9 (0.2%); and chills or rigors, 6 (0.2%). Rates for other specific events were < or =0.1 percent. Vasovagal phenomena were more frequent in procedures done in neurologic patients than in those done in hematology or oncology patients (p = 0.011) or renal or rheumatic patients (p = 0.038). Procedure-specific rates were red cell exchange, 8 (10.26%) of 78; PE (plasma), 89 (7.81 %) of 1140; PE (no plasma), 42 (3.35%) of 1255; leukapheresis, 4 (5.71%) of 70; plateletpheresis, 0 of 18; and autologous peripheral blood progenitor cell collection, 11 (1.66%) of 664. Three deaths were reported; all were attributed to primary disease. CONCLUSION: Therapeutic apheresis procedures are relatively safe, with a 4.75-percent overall incidence of mostly reversible adverse effects. Among the most commonly performed procedures, the risk is higher for blood component exchanges, especially if allogeneic red cell or plasma transfusion occurs, and lower for peripheral blood progenitor cell collection.

Anticoagulants↗
PubMed2001

Implementation of a blood irradiation program at a community cancer center.

BACKGROUND: Blood component irradiation is an accepted method of preventing transfusion-associated GVHD. Previous publications have largely focused on the technical aspects of the irradiation process itself, but relatively little attention has been paid to the details associated with the implementation of a blood irradiation program at the level of a community cancer center. STUDY DESIGN AND METHODS: An observational study was performed, detailing the specific operational, documentation, and quality assurance measures employed in providing a blood component-irradiation service within the institutional context of a community cancer center. RESULTS: The Montgomery Cancer Center irradiated 589 units of blood components in 1998 and 1999 to provide a local blood bank with an alternative for procurement of irradiated blood components while complying with applicable quality assurance and regulatory requirements. CONCLUSION: Blood component irradiation is within the scope of most well-equipped and adequately staffed community cancer centers. Establishment of a blood component irradiation program requires scrupulous physics and dosimetry support, both to ensure the quality of the irradiated component and to satisfy governmental agency regulatory requirements.

Alabama↗
PubMed2003

Protein composition and activation markers in plasma collected by three apheresis procedures.

BACKGROUND: Scientific and technical advances made in transfusion medicine sustain the need for more comprehensive understanding of the impact of collection procedures on the quality of plasma for fractionation and for transfusion. This prospective work evaluated protein composition and markers of activation in plasma donations collected with three different automatic collection procedures (performed on Haemonetics machines), including a new procedure using a high-separation core-molded bowl. STUDY DESIGN AND METHODS: A total of 90 collection procedures have been performed from a population of 37 donors, under comprehensively standardized conditions. Plasma aliquots were taken from the plasma units within 30 minutes of the end of the collection procedures and immediately frozen at -70 degrees C. Content in an extended range of proteins and of markers of activation of the coagulation and fibrinolytic systems has been measured using standard in vitro testing methods. RESULTS: Plasma donations had normal mean total protein, IgG, IgM, and fibrinogen content. The mean levels in coagulation FV, FVII, FVIII, and FXI and in antithrombin were above the standard international requirements. There was no sign of activation of the hemostasis system, as assessed by activated FVII, thrombin antithrombin complex, Prothrombin fragment 1+2, and D-dimers. Activated complement component C3 and C5 were low. CONCLUSION: Data indicates the good and consistent protein composition of plasma obtained by those automatic apheresis procedures. In particular, the new high-separation core procedure yields a high-quality plasma meeting requirements for transfusion and fractionation.

Adult↗