Thrombin generation before and after multicomponent blood collection

The development of apheresis technology has increased efficiency in donor blood use by collecting specific blood components in several combinations. The question of donor safety raised by the contact of donor blood with foreign, only in part biocompatible surfaces remains. The aim of this study was to estimate the effect of multicomponent blood collection on thrombin generation performing an overall function test of coagulation. DONORS, METHODS: 26 blood donors were included. Per apheresis two units of platelets and one unit of RBCs were collected by two cell separators (Amicus and Trima Accel). Each donor underwent the procedure on both apheresis systems. Samples were collected before, immediately after, and 48 hours after apheresis. Thrombin generation was measured by means of calibrated automated thrombography (CAT). RESULTS: CAT-data changed only slightly and no significant changes were seen before, immediately after, and 48 hours after apheresis. The parameters did not differ significantly between the two different apheresis devices. CONCLUSION: No change in parameters of continuous thrombin generation occurred, suggesting that apheresis did not lead to severe alterations in the haemostatic system.     

Thrombin generation before and after multicomponent blood collection

BACKGROUND: Apheresis technology has made tremendous progress up to the development of automated blood component collection, which offers increased efficiency in donor blood use, but the concern about the contact of donor blood with artificial surfaces remains. Activation of the hemostatic system is a major issue in this context and is controversial. The aim of this study was to estimate the effect of apheresis on continuous thrombin generation (TG), representing a new tool to examine the overall function of the plasmatic clotting system. STUDY DESIGN AND METHODS: Twenty-six voluntary blood donors, fulfilling the law requirement for apheresis donation, participated in the study. Two units of platelets (6 x 10(11)) and 1 unit of red cells (250 mL; hematocrit level, 80%) were collected using two types of cell separators (Amicus, Fenwal, Inc.; and Trima Accel, Gambro BCT). Each donor underwent collection on both apheresis systems with at least 8 weeks in between. Samples of blood were collected before, immediately after, and 48 hours after apheresis. TG was measured using a slow fluorogenic substrate by means of calibrated automated thrombography (CAT). RESULTS: CAT data changed only slightly, and no significant changes were seen before, immediately after, and 48 hours after apheresis (p > 0.05). The variables did not differ significantly between the two different apheresis systems (p > 0.05). CONCLUSION: Using a CAT-based technique, no change in variables of continuous TG were observed, suggesting that multicomponent blood collection did not lead to severe alterations in the hemostatic system of the donors.     

A comparative labor productivity analysis of blood collection centers

BACKGROUND: Blood center labor benchmarking data may be helpful to optimize staffing and to establish productivity targets. Data were gathered and labor productivity was analyzed among blood donor centers of different sizes collecting different product mixes. STUDY DESIGN AND METHODS: Blood collection volumes and blood center labor data were obtained from eight blood centers: six regional centers, one mobile collection operation, and our hospital-affiliated center. A total of 2004 annual whole-blood (WB) collections and apheresis platelet (PLT) collections were captured. Full-time equivalents (FTEs) associated with blood collection operations were captured. With these data total unit (WB + PLT) collection rates per FTE were calculated. To compare value associated with each center's total unit collections, an indexed monetary value was assigned to WB and PLT and the value was calculated. RESULTS: Despite a 12-fold range in the size of operations, there was a strong correlation between total annual products collected and number of FTEs (mean 460 +/- 39 units/FTE). As expected, centers that collected relatively more PLTs had higher value per total unit collected. Surprisingly, however, there was no relationship between proportion of PLTs collected and total units collected per FTE. Centers collecting proportionately more PLTs therefore had higher value per FTE. CONCLUSION: A benchmark scale of labor productivity among blood donor centers of different sizes and product mixes was established. Product mix is not a major determinant of total unit collections per FTE but is an important determinant of value per FTE. Correlating collection targets with benchmark data from this survey may help determine optimal blood center labor allocation strategies.     

Postdonation platelet counts are safe when collecting platelets with the Trima Accel using a postdonation platelet count target of ≥50,000 platelets/μL

In December 2007, the FDA issued a guidance document recommending that apheresis cell separators be configured with a postdonation platelet count target of ≥100,000 platelets/μL. Currently, our Trima Accel apheresis cell separators are configured with a postdonation platelet count target of ≥50,000 platelets/μL. To determine the safety of our current procedure, we analyzed the postdonation platelet counts of 115 donors collected using our current procedure. All of 115 donors had postdonation platelet counts ≥100,000 platelets/μL. On the basis of predonation platelet counts, we calculated that raising the postdonation target platelet count to ≥100,000 platelets/μL would have disqualified 19 out of 225 potential platelet products. We conclude that the current postdonation platelet count target of ≥50,000 platelets/μL is safe for donors collected using the Trima Accel. Efforts to reduce the incidence of TRALI are creating challenges for the platelet supply. Increasing the postdonation platelet count target to ≥100,000 platelets/μL will reduce productivity in apheresis platelet collection and may not enhance donor safety. J. Clin. Apheresis 2009. © 2009 Wiley‐Liss, Inc.     

Implementation of a strategy to prevent TRALI in a regional blood centre

Transfusion-related acute lung injury (TRALI) can be a life-threatening complication of transfusion and it is probably underdiagnosed. Human leucocyte antigen (HLA) and granulocyte antibodies are thought to play a major role, but preventive measures are difficult to implement. In our regional blood centre, we implemented a preventive strategy avoiding donor deferral. Previously, pregnant apheresis donors were screened for HLA antibodies, and those with positive results were assigned to a plasma-only protocol. Plasma from these donors and from all previously pregnant whole blood donors was diverted for protein fractionation. Plasma-poor red blood cells (in additive solution, buffy coat removed) and platelets (pools with additive solution) were prepared. Prestorage leucodepletion was also applied. We found HLA antibodies in 18.1% of previously pregnant apheresis donors, and our strategy caused a 6.0% loss of apheresis platelets, a 4.8% increase of apheresis fresh frozen plasma (FFP) and a 7.8% loss of transfusable apheresis FFP. The effect on FFP from whole blood donors could be compensated. The platelet preparation method reduced the mean volume of plasma from each donor to 24.4 mL. Fifteen months after the start of our strategy, no cases of TRALI have been reported. Our experience shows that a practical strategy to prevent TRALI is feasible.     

Plasma lipemia: When the blood donor becomes a patient

Lipemic plasma donations are not a strange phenomenon to blood bankers. According to quality standards for plasma fractionation, lipemic plasma donations must be discarded. Beyond quality control and inventory aspects, plasma lipemia is also an important risk factor for cardiovascular diseases, acute pancreatitis and is associated with overall mortality, however little attention is given to the management of these donors in the literature.A retrospective analysis of every whole blood donation that yielded lipemic plasma between January 1st 2018 and December 31st 2019 was made. The medical examination and donor history for the respective donation was reviewed and the available data was collected regarding hour of donation, gender, age, drugs and coexisting pathologies. Whether the donor was called back for a follow up evaluation regarding the lipemic plasma was also noted.Our blood center received 18274 whole blood donations of which 115 (0,63 %) were reported as having plasma lipemia, in the period of this study. Of these 115 donors, 103 (89,57 %) were male. The average age was 47,63 ± 10,65 years. A clear peak in lipemic plasma donations 4 hours after the classic lunch hours is visible. For 88,70 % of the donors, this was the first time their hypertriglyceridemia was identified.The nonfasting elevation of plasma triglycerides in these donors represents a true metabolic derangement. This is a golden opportunity for early intervention and follow up evaluation is indicated. More attention must be given during the medical evaluation to properly identify donors at risk of lipemic donations.     

Comparative study of automated plateletpheresis using five different apheresis systems in a tertiary care hospital

Different types of cell separators are available nowadays based on either continuous or intermittent flow technology to meet the growing demands for single donor apheresis platelets. This prospective study compares the five machines used in our center with regard to procedure parameters, product quality and adverse effects on the donor.A total of 477 plateletpheresis on various machines were performed on eligible donors over a period of 28 months after taking informed consent. All procedures were performed following the departmental standard operating procedure (SOP) and manufacturer’s instructions. All donor and procedure related details were obtained from the procedure register. Statistical analysis was done using the SPSS statistical package (version 12, USA).The median age, BSA and BMI of our plateletpheresis donors were calculated to be 29 years, 1.69 m² and 23.1 kg/m², respectively. Analyzing the parameters related to donor comfort such as donation time (DT), needle time (NT) and processing time (PT), the MCS machines were not “donor friendly” compared to Amicus and Fresenius. Platelet yield by Amicus was significantly higher as compared to other cell separators (p < 0.05). Plateletpheresis associated citrate toxicity was higher with the Amicus and MCS 3p and vasovagal side-effects was observed least with the CS 3000 machine. Though, quality of apheresis product in terms of yield is comparable with all the machines, there are differences in the systems with regard to donor safety, procedure time and donor retention.     

Strategies to recruit plateletpheresis donors from a registry of HLA- typed, unrelated, bone marrow donors

Rising demand for single-donor platelet components–from random donors, to maintain platelet inventories, or from HLA-compatible donors, to support alloimmune platelet-refractory patients–necessitated increasing the size of a community plateletpheresis donor registry. This study compares two strategies for recruiting whole-blood donors into a plateletpheresis program. The whole-blood donors who were asked to participate in this study had recently joined an unrelated bone marrow donor registry and had been HLA-typed as part of that process. An in-person recruitment strategy, which was time-intensive for the apheresis donor coordinator, served as the standard. A by-mail strategy involved the mailing of recruitment materials to marrow-donor registry participants. Marrow-donor registry participants were approached about apheresis participation after they had indicated an interest in the plateletpheresis program by returning a tear-off section of an informational brochure that was sent to them along with their marrow- donor registry materials. A total of 852 marrow-donor registry participants were randomly assigned to one of two recruitment strategies, and the recruitment rates were the same (46%) for both methods. In addition, levels of apheresis participation and attrition rates of donors recruited by either strategy were comparable. Thus, the simple strategy of mailing information about a plateletpheresis program is a very cost-effective method of recruiting donors.     

Safety of donating multiple products in a single apheresis collection: Are we expecting too much?

Modern blood separators rapidly process many liters of donor blood and efficiently collect vast quantities of blood components from donors, who may be stimulated with potent recombinant hematopoietic growth factors or cytokines. Accordingly, the potential risks of modern multiple product/unit apheresis donations and recombinant growth factors is analyzed in this report. As is true for all medical procedures, risks are associated with apheresis donations. Risks of a "standard" apheresis donation, in which one unit of PLTs or plasma is collected, are comparable to the risks of whole blood donation. Risks of multiple unit apheresis donations, in which either vast quantities of a single blood component or multiple units of various components are collected, are incompletely understood, particularly, when donors are stimulated with recombinant hematopoietic growth factors to increase component yields. To minimize donor risks and to increase knowledge of multiple component apheresis donations, both short-term problems (e.g., donor reactions accompanying apheresis procedures and pre- vs. post-procedure changes in results of donor laboratory studies) and long-term problems (e.g., medical diagnoses/problems and abnormalities of donor blood counts and laboratory test results) should be monitored, ideally, by a repeat donor registry. When recombinant hematopoietic growth factors are prescribed, donors should give informed consent, and blood center professionals must be aware of 1) the effects of these drugs given at pharmacologic, rather than physiologic, doses; 2) the differences between the molecular structure of recombinant vs. natural/endogenous growth factors; 3) the fact that recombinant growth factors have both narrow/focused and broad biological activities; and 4) the probability that results of studies in sick/immunosuppressed patients may not be applicable to healthy/immunocompetent donors.     

Volunteer donor apheresis.

Volunteer donor apheresis has evolved from early plasmapheresis procedures that collected single components into technically advanced multicomponent procedures that can produce combinations of red blood cells, platelets, and plasma units. Blood collection and utilization is increasing annually in the United States. The number of apheresis procedures is also increasing such that single donor platelet transfusions now exceed platelet concentrates from random donors. Donor qualifications for apheresis vary from those of whole blood. Depending on the procedure, the donor weight, donation interval, and platelet count must be taken into consideration. Adverse effects of apheresis are well known and fortunately occur in only a very small percentage of donors. The recruitment of volunteer donors is one of the most challenging aspects of a successful apheresis program. As multicomponent apheresis becomes more commonplace, it is important for collection centers to analyze the best methods to recruit and collect donors.     

Comparison of the effectiveness of potential marrow donors recruited from apheresis donors or whole blood donors and through appeals to the general public

Marrow transplants with phenotypically HLA-matched, unrelated donors have been used effectively to treat a number of diseases. Many blood centers have recruited HLA-typed apheresis blood donors into marrow donor registries. However, to build larger registries so that more patients may be treated with unrelated donor marrow transplants, whole blood donors and people who do not donate blood have been added to the registries. The marrow donor program at our blood center had 2844 potential donors, of whom 1725 were also apheresis donors, 608 were whole blood donors, and 511 were recruited from the general public as a result of community appeals for marrow donors for a specific patient. Over a 9-month period, 297 potential donors were asked to donate blood samples for HLA-DR typing or mixed lymphocyte culture (MLC) testing or to participate in an informational session, undergo a medical evaluation, and sign a statement indicating an intention to donate marrow for a specific patient. Overall, these requests were successfully completed by 75.5 percent of apheresis donors, 87.2 percent of whole blood donors, and 78.1 percent of the potential donors recruited through community appeals. Furthermore, there was no difference among the three groups in the portion of people who donated blood samples for HLA-DR typing or MLC testing. Fifteen of 18 apheresis donors who were found to match a specific donor signed a statement of intent to donate marrow, 2 apheresis donors were deferred for medical reasons, and 1 decided not to donate.(ABSTRACT TRUNCATED AT 250 WORDS)     

Blood donor deferral in Minas Gerais State, Brazil: blood centers as sentinels of urban population health

BACKGROUND: Shortage of safe blood donors is frequent and it is important to understand the causes of deferral of potential donors, who reside mainly in urban areas, to improve recruitment campaigns aiming at the quality/availability of donors.
STUDY DESIGN AND METHODS: In Minas Gerais State, Brazil, Hemominas Foundation collects, analyzes, and distributes more than 90 percent of blood. Blood is collected in 19 centers in cities. In 2006, data from 335,109 attempts to donate were analyzed.
RESULTS: Seventy-seven percent of donor candidates were less than 40 years old, with 57.1 percent nonwhite and 66 percent male. A total of 21.6 percent were deferred at the interview. Women were more clinically deferred than men (25.5% vs. 19.6%). In larger cities, the proportion of first-time donors (FTs) was higher (67.8%). The main causes of permanent deferral among FTs were neurologic diseases (37.5%), chronic hypertension (22.2%), and endocrinologic diseases (9.9%). The main causes of temporary clinical deferral in this group were risky behavior for sexually transmitted diseases (32.6%), anemia (8.5%), and hypertension (6%). The main causes of permanent deferral in repeat donors (RTs) were chronic hypertension (31.6%) and neurologic diseases (22.1%); for temporary deferral it was anemia (22.6%). A total of 2.9% of the collected blood bags were discarded due to reactive tests (FTs = 34.82/1000; RTs = 3.51/1000).
CONCLUSION: A deferral study in blood donor candidates may shed light on regional diversity, highlighting how social inequalities and health status of the general population may affect the blood supply. Risk factors and marker rates derived from the donor pool may be useful to gain insights regarding public health issues.     

Effectiveness of different methods of blood separation in performing plasma- and cytapheresis

Obtaining of a therapeutic dose of platelets from donors, necessary to stop spontaneous hemorrhage and sufficient enough to correct hemostasis in surgical interventions in patients with amegakaryocytic thrombocytopenia, therapeutic plasmapheresis with the removal of 1.5-2.01 of plasma, effective erythrocytapheresis can be done with the help of refrigerator centrifuges and plastic containers. This method can be also employed for effective leukocytapheresis in patients with the leukocyte level exceeding 100.10(9)/l. It is simple, economical, reliable; several donors (patients) can be involved in the procedure at a time. Blood cell separators can be most effectively used for therapeutic lymphocytoplasmapheresis, massive plasmapheresis with the removal of over 2.51 of plasma, for obtaining a large number of platelets and granulocytes. The CS-3000 blood cell separator ensures automatic control over blood separation and possible complications during a procedure; a constant temperature regimen of blood separation; one-time use of equipment in direct contact with patient's (donor's) blood; a high efficacy and safety of the procedure.     

Allogeneic blood progenitor cell collection in normal donors after mobilization with filgrastim: the M.D. Anderson Cancer Center experience

BACKGROUND: Information on the safety and efficacy of allogeneic peripheral blood progenitor cell (PBPC) collection in filgrastim-mobilized normal donors is still limited. STUDY DESIGN AND METHODS: The PBPC donor database from a 42-month period (12/94-5/98) was reviewed for apheresis and clinical data related to PBPC donation. Normal PBPC donors received filgrastim (6 microg/kg subcutaneously every 12 hours) for 3 to 4 days and subsequently underwent daily leukapheresis. The target collection was > or =4 x 10(6)CD34+ cells per kg of recipient's body weight. RESULTS: A total of 350 donors were found to be evaluable. Their median age was 41 years (range, 4-79). Their median preapheresis white cell count was 42.8 x 10(9) per L (range, 18.3-91.6). Of these donors, 17 (5%) had inadequate peripheral venous access. Leukapheresis could not be completed because of apheresis-related adverse events in 2 donors (0.5%). Of the 324 donors evaluable for apheresis yield data, 221 (68%) reached the collection target with one leukapheresis. The median CD34+ cell dose collected (first leukapheresis) was 462 x 10(6) (range, 29-1463).The main adverse events related to filgrastim administration in donors evaluable for toxicity (n = 341) were bone pain (84%), headache (54%), fatigue (31%), and nausea (13%). These events were rated as moderate to severe (grade 2-3) by 171 (50%) of the donors. In 2 donors (0.5%), they prompted the discontinuation of filgrastim administration. CONCLUSION: PBPC apheresis for allogeneic transplantation is safe and well tolerated. It allows the collection of an "acceptable" PBPC dose in most normal donors with one leukapheresis, with minimal need for invasive procedures.     

Comparison of platelet loss during leukocyte reduction at 4, 24, and 48 hours postcollection using a closed system apheresis kit with integral filter

Prestorage leukocyte reduction of platelet concentrates may reduce adverse effects of transfusion while affording better quality control. Platelets and leukocytes may undergo activation during storage, which could affect the performance of leukocyte reduction filters. The purpose of this study was to evaluate the efficiency of leukocyte reduction and concomitant platelet loss with a new apheresis kit with an integral leukocyte reduction filter. Twelve donors underwent plateletpheresis on three occasions using the CS-3000 PLUS Blood Cell Separator with the Access™ Management System and the Access™ Closed System Apheresis Kit with Integral Sepacell® Leukocyte Reduction Filter and Double Return Line Needle (Baxter-Fenwal Division, Deerfield, IL). Of the three products from each donor, one each was filtered at 4, 24, and 48 hours completion of the plateletpheresis. Mean prefiltration platelet count was 4.43 × 10¹¹ and mean postfiltration platelet count was 3.56 × 10¹¹. Mean platelet recovery at 4, 24, and 48 hours filtration was 75%, 83%, and 84%, respectively. Analysis of variance (ANOVA) demonstrated that platelet recovery with filtration at four hours was significantly less than with filtration at 24 hours (P = 0.0236) and filtration at 48 hours (P = 0.0122). Platelet recovery with filtration at 24 hour did not differ significantly from filtration at 48 hours (P = 0.7684). Mean prefiltration WBC count was 0.93 × 10⁶ and mean postfiltration WBC count was 0.12 × 10⁶. Efficiency of leukocyte reduction was not significantly related to when filtration was performed. There was no significant variation from donor to donor in platelet recovery or in leukocyte reduction efficiency. This method of prestorage leukocyte reduction demonstrated slightly but statistically significantly better platelet recovery with filtration at 24 or 48 hours after platelet collection compared to four hours. All filtration times provided acceptable platelet yields with very low residual WBC. J. Clin. Apheresis 12:14–17, 1997 © 1997 Wiley-Liss, Inc.     

Therapeutic apheresis services provided by a community blood bank.

Therapeutic apheresis services can be provided from a community-based blood center. The Oklahoma Blood Institute uses a mobile approach, primarily servicing 10 major hospitals in the Oklahoma City metropolitan area within a 15 to 20 mile radius. Apheresis staff and equipment are available 24 hours per day, 7 days per week in the event of patient referral requiring an emergency therapeutic apheresis procedure. This model requires close communication between the therapeutic apheresis medical director and the referring clinician. Telephone and facsimile transmissions of information are used to facilitate the transfer of information to all persons/facilities involved in providing treatment. This approach has proven effective in providing the required procedures for a referral population base of several million people spread over a fairly large geographic area.     

Apheresis activity in Venezuela

Interest for apheresis activity has been growing in Venezuela. In 1976 there were only a few devices; in 2003, 80 apheresis machines performed 27,675 donor apheresis procedures and 547 therapeutic procedures countrywide. We report the activity at the Metropolitan Blood Bank (the largest one of the country) in the period 1999-2003: 597 therapeutic procedures were performed in 171 patients, during 212 crisis episodes. The average age was 38 +/- 16 years, 65% male and 35% female. Most of the therapeutic procedures were therapeutic plasma exchange for hematology diseases (mainly thrombotic thrombocitopenic purpura and hemophilia inhibitors), including 184 therapeutic procedures with the Autopheresis-C (Baxter Healthcare Corp., Deerfield, IL). Most common adverse effects (3.9%) were hypotension and allergic reactions to the plasma.     

Prolonged circulation of activated platelets following plasmapheresis

The extent and duration of in vivo platelet activation were determined in 12 volunteer donors undergoing automated plasmapheresis. Expression of P-selectin, activated GpIIb/IIIa, and platelet microparticle formation were measured by flow cytometry on peripheral blood samples obtained immediately before and after plasmapheresis and at 24 hour intervals thereafter for up to 3 days. Although no adverse effects were noted in any donor, immediately after apheresis 3 87% of circulating platelets expressed P-selectin: by 48 hours. 0.5 50% expressed P-selectin; and by 72 hours, all donors studied had fewer than 5% P-selectin expression on circulating platelets. Results were similar for the expression of the activated conformation of GpIIb/IIIa. There was a positive correlation with in vitro P-selectin expression in response to ADP in the pre-apheresis sample and the number of platelet microparticles detected in the donor following plasmapheresis. In addition, the percent expression of P-selectin and activated GpIIb/IIIa in response to ADP was reproducible in each individual studied on five separate occasions (CV ≤ 8%). Platelets activated during plasmapheresis using an automated device may circulate for at least 48 hours, and pre-plasmapheresis response of platelets to the agonist ADP correlated with platelet microparticle formation post-plasmapheresis. © 1994 Wiley-Liss, Inc.     

Matching blood donations to type-specific product needs: A recruitment technique

The conversion of multiple whole blood donors to apheresis donors is a challenge since a rapidly expanding apheresis donor base could erode homologous collections. We addressed this concern with a plan to enhance apheresis recruitment as well as donations among homologous donors with types O and B blood. Focusing the donor's attention on blood type as it relates to type-specific product needs was the basis of our approach. A matrix was used to recruit the desired types for the desired procedures (whole blood, platelet/plasma apheresis). The matrix instructed donors of blood types O, A-, and B- to primarily give whole blood and to give apheresis as a secondary donation. Donors AB, A+, and B+ were primarily directed to apheresis donations, whole blood donation being secondary. A+ and O- donors only gave their secondary donation if they were at maximum donations with the primary donation. The collections by blood type in percentages for 12 months of 1992/93 for whole blood were O+ 38.9, 0- 7.3, A+ 29.5, A- 5.7, B+ 11.9, B- 2.1, AB+ 3.7, AB+ 0.7. For apheresis it was 0+ 36.2, 0- 6.7, A+ 33.0, A- 6.6, B+ 10.4, B- 1.2, AB+ 4.9, AB+ 1.0. In 1992/93, A+ and B+ apheresis collections as compared to total apheresis collections increased by 4.9% and 13.7%, respectively. For O group apheresis donations, a decrease of 2.5% was shown and A+ whole blood donations decreased by 5.35%. During the same period of time, total apheresis collections increased by 3,058 units. We demonstrated that integration of apheresis recruitment with type-specific whole blood recruitment yielded significant increases of type-specific products.