Plasma Bag Research Articles

Design and Experimentation of a Residual-Input Tube-End Cutting System for Plasma Bags Based on Machine Vision

In response to the lack of plasma bag-breaking equipment and time-consuming manual recovery of plasma in China, this study focuses on the distal end cutting of a plasma bag residual-input tube and designs a machine-vision-based plasma bag residual-input tube cutting system. The system comprises a plasma bag rotation device, a bottom disc, an image acquisition device, a cutting device, and a device control system. The image acquisition device captures images of the rotating plasma bag and calculates the Euclidean distance from the end of the plasma bag input-tube distal end to the outer edge of the bottom support plate and the distance from the input-tube distal end to the centerline of the plasma bag. Two distinct value acquisition algorithms are designed for the two types of input tubes. The screw slide moves accordingly. When the plasma bag is above the cutting part, the cutting part cuts the end of the residual-input tube of the plasma bag. The prototype performance tests reveal that the cutting error is within 10% of the end of the plasma bag input tube distal end, the cutting success rate is 100%, and the processing time for each bag is 2.5 s, which meets the time requirements of the plasma bag breaker.

Review and assessment of the donor safety among plasma donors.

Review and assessment of the donor safety among plasma donors.

Root Cause Analysis of a Moderately Large Fibrinous Coagulum in a Thawed Fresh Frozen Plasma Bag

Root Cause Analysis of a Moderately Large Fibrinous Coagulum in a Thawed Fresh Frozen Plasma Bag

A Simple Quick Method of Draining Red Cells from Granulocyte Concentrates Ex Vivo without the Addition of Hetastarch after Granulocytapheresis

Introduction Granulocytapheresis from healthy volunteer donors are performed regularly at our institution to treat severely neutropenic leukemia/SCT patients with overwhelming bacterial/fungal infections. 500 to 750 mL of Hespan® (6% hetastarch in 0.9% sodium chloride injection) with citrate anticoagulant is administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:13 to venous whole blood. The traditional method of gravity sedimentation of Granulocyte concentrates (GC) is the addition of 50 cc of 6% Hydroxyethyl starch in ACD anticoagulant which results in RBC volume reduction to < 5ml (range acceptable for transfusion to ABO incompatible recipients according to AABB standards). The method is time consuming, tedious and adds additional HES to the product. We streamlined the process by allowing the sedimented red cells to drain via gravity upon completion of the apheresis procedure without the addition of Hetastarch. Method: GCs are obtained from prescreened eligible (meet AABB/FDA guidelines) family/friends of the patients. G-CSF is administered as a fixed dose of 480 mcg (donors < 250 lbs.) or as 2 doses of 300/480 mcg (donors > 250 lbs) plus 8 mg of dexamethasone (without history of cataracts) 12 hours prior to the collection. 30 ml of TriCitrasol Anticoagulant (46.7% Trisodium citrate) is added to 500 ml of 6% Hetastarch in 0.9% Sodium Chloride Injection for IV use only and not more than 1000 ml is used in a single GC apheresis procedure. Our current practice is to test all O blood group donors for Anti-A Isoagglutinin titers. Cut off titers are set at <128. GCs from group O donors with Anti-A titers > 128 are drained of red cells if the recipient is non-O. For pediatric patients, our practice is to drain all GC products regardless of ABO compatibility between donor and recipient. Process: Upon completion of the Granulocytaheresis, the GC collection bag is left undisturbed hanging on the IV pole leaving all slips clamps attached. Red cells collected during the apheresis procedure settle at the base the collection bag. The collection line of the GC collection bag is clamped distal to the attachment of the sterile barrier filter inclusive of the sample bulb assembly. The clamp proximal to the sample bulb assembly needs to be left clamped. The collection bag is then sterile docked to a transfer bag (the plasma bag from the IDL set can be used) to create a closed sterile system. Two hemostats clamps are placed, one close to the inlet port of the collection bag and the other close to the sterile dock of the transfer bag. The clamps are opened slowly and the sedimented red cells are allowed to slowly drain into the transfer bag. Pressure using two fingers may be used to create a funnel to express the sedimented red cells into the port from the GC unit. When the desired amount of red cells are expressed into the transfer bag the process is stopped. The transfer bag is then removed by clamping and a relatively clean GC product is now available for transfusion. The entire process takes approximately 10-15 minutes. The GC bag is then sampled via the incorporated sample bulbs for the bag count, then labelled ready for release for transfusion. Results: We reviewed the results of six drained GCs by this method; the median Bag RBC was 0.8 x10e6/uL (range 0.06 - 0.23), Bag Hgb 0.8 g/dL (range 0.5-1.0) and Bag Hematocrit 0.7% (range 0.6-2.6). The median Bag WBC count was 10.6 x 10e10 (range 5.8 to 15.1), median bag volume 641 mL (range 462-774) and median volume processed 10526 ml (range 8800-12175 mL). We achieved our goal of reducing the red cells to <2 ml, providing a GC with more than the minimum yield (1.0 x 10e10) required according to AABB standards and also the availability of a GC product within 2 hours of completion for transfusion. Discussion: The use of the newer Apheresis machine allows for efficient removal of the targeted component and monitors/adjusts the depth at which the cells are collected within the Buffy coat layer based on the desired hematocrit of the collected product. Our practice is to collect a relatively clean GC product where there is less than 2 mL of red cell contamination in the GC unit. However, this is not always achieved and the GC units do have to be drained. Approximately 10-25 mL of red cells are drained depending on the collection and the GC units drained in this manner are comparable to the GCs drained after the addition of 50 cc of Hetastarch to the GC product. Disclosures No relevant conflicts of interest to declare.

Purification of canine albumin by heat denaturation in a plasma bag.

To design and evaluate a method to purify canine albumin from fresh frozen plasma (FFP) or stored plasma (SP) in a manner that could be applied clinically. In vitro experimental study. FDA licensed Blood Bank Laboratory and University biochemistry laboratory. None. Using equipment that is typically found in veterinary blood banks, plasma bags were thawed, injected with the heat stabilizing agent, sodium caprylate, and then heated and acidified to denature all but albumin proteins. Albumin-rich supernatant was removed, the pH was neutralized, and then pasteurized and refrigerated. Albumin and total plasma protein concentrations were measured and the product was cultured for bacteria at 0, 7, 14, 30, and 60 days post-processing. Seventeen bags of plasma were analyzed for purity, yield, and sterility of the finished albumin product. Bags were divided into categories based on the age of the frozen plasma. Mean yield of albumin for all bags was 77.3% and mean purity was 91.2%. There was no difference between old stored plasma, new stored plasma, and FFP with regard to yield (P=0.31) or purity (P=0.24) based on one-way analysis of variances. Overall 1 of 17 bags of plasma (5.9%) tested positive for bacterial contamination on day 60 after processing. Sodium caprylate is able to stabilize canine albumin enabling it to withstand heating that denatures other plasma proteins. The resulting albumin product is of sufficient quality to potentially be used therapeutically as a colloidal resuscitative fluid. Further study is needed into its safety and effect in dogs.

Minimizing Time to Plasma Administration and Fresh Frozen Plasma Waste: A Multimodal Approach to Improve Massive Transfusion at a Level 1 Trauma Center.

Massive transfusion protocols are part of damage control resuscitation for hemorrhaging trauma patients with the goal of returning the patient to hemodynamic stability. It is essential that patients receive blood products immediately and in the proper ratios. At our metropolitan Level 1 trauma center, we identified several challenges to deploying massive transfusion rapidly and within the recommended ratio guidelines. In 2016, we implemented a quality improvement project addressing 4 opportunities: fresh frozen plasma (FFP) bag breakage, plasma options, blood bank equipment, and multidisciplinary policy revision. Implementing packaging and shipping improvements, utilization of new products, and updating protocols have resulted in a 50% decrease in FFP bag breakage rates, a dramatic decrease in time for patients receiving massive transfusion to receive plasma products (mean time 3.5 min), and patients being administered the recommended ratio of blood products.

Role of signal-to-cut-off ratios of anti-hepatitis C virus antibody by enzyme immunoassays along with ID-NAT for screening of whole blood donors in India.

Background:The use of elevated signal-to-cut off ratios (S/CO) as an alternate to further supplemental testing (i.e., RIBA) has been included in the guidelines provided by the Centres for Disease Control and Prevention for HCV diagnostic purposes since 2003. With availability of screening by NAT and non availability of RIBA, further confirmation of HCV infection has been possible at the molecular level (RNA).Aims:To study the role of S/CO ratios of anti hepatitis C virus antibody detection by enzyme immunoassays (EIA) along with ID-NAT for screening of whole blood donors.Methods:In this study we reviewed the donor screening status for anti HCV from January 2013 to May 2014. All the donations were screened for anti HCV with fourth generation ELISA (BioRad Monolisa Ag-Ab Ultra) as well as with ID NAT (Procleix Ultrio). The S/CO ratio of all the anti-HCV reactive samples were analysed for their presence of HCV RNA.Results:On screening 21,115 donors for HCV, 83 donors (0.39%) were found reactive on pilot tube and repeat plasma bag testing (S/Co ratio ≥1) by ELISA. 41 donors were HCV RNA reactive with ID-NAT. 4 samples out of 41 were NAT yields and 37 were concordant reactive with ELISA. The S/Co ratio of anti-HCV reactive samples ranged from 0.9-11.1 [mean = 5.1; SD ± 2.9] whereas S/Co ratio of anti HCV and NAT reactive samples (concordant positives) ranged from 4.1-11.1 [mean 7.3]. In our analysis we found that S/CO ratio of 4 showed positive predictive value (PPV) and sensitivity of 100%.Summary/Conclusions:Our study showed that S/CO of 4 for anti HCV on ELISA would have maximum positive predictive value of having donor with HCV RNA. S/CO ratio of 4 is very close to 3.8 which was the CDC guideline. The presence of anti-HCV does not distinguish between current or past infections but a confirmed anti-HCV-positive result indicates the need for counseling and medical evaluation for HCV infection.

Donor leucocyte buffy coat infusion to patients with donor specific hla antibodies undergoing haploidentical hematopoietic stem cell transplantation

Aim Haploidentical stem cell transplantation (SCT) is an alternative option to treat high risk patients lacking HLA identical donors. When the patient has donor specific antibodies against the Haploidentical donor(s) and there is a need for the patient to undergo transplantation, the question arises as to whether to proceed with the transplantation. It is known that the detection of donor-directed HLA specific alloantibodies (DSA) in recipients of unrelated hematopoietic stem cell transplantations is predictive of graft failure. Method Five ([5 Females: 0 Males], age median 45 years [range 24–63], diagnosis [AML (2)/Acute Erythroid Leukemia (1)/Myelofibrosis (1)/Aplastic Anemia (1)] patients with DSAs underwent Haploidentical SCT after undergoing a desensitization protocol of Rituxan/Plasma Exchange/IVG prior to transplant followed by an infusion of Donor Leucocyte buffy coat on Day-1. The buffy coat was prepared from an autologous unit of whole blood from the Haplo donor on Day-2. The blood was separated within 8 hours of collection into platelet rich plasma and packed red cells. Approximately 40–50 cc of red cells inclusive of the buffy coat was allowed to be collected in a platelet rich plasma bag. A second centrifugation separated the plasma from the red cells and the buffy coat component. The buffy coat component was then cross matched and infused to the patient. Results All five patients engrafted median 33 (range 28–40) days post-transplant. Four are alive with median follow-up of 566 days from transplant (range 408–730 days). Two patients are in disease remission (553 and 600 days from transplant), the disease recurred in 2 patients (408 and 730 days from transplant) and one patient died of a viral infection on post-transplant Day 88. Conclusion Although our numbers are small we believe that Leucocyte Buffy coat infusion after desensitization is a very promising approach for patients with DSAs undergoing Haploidentical stem cell transplantation. Download : Download full-size image

Preparation of albumin from human plasma by heat denaturation method in plasma bag

In many countries, there is surplus plasma which is thrown out. Due to the high cost of albumin as a pharmaceutical product, it is not widely available for all patients. Therefore, we considered direct preparation of albumin in the plasma bag. Human plasma has many unique features compared with prepared pharmaceutical products because of its human origin. In countries which do not have a plasma fractionation industry, shortages for plasma products are commonplace. Albumin stabiliser was added to the plasma in the bag to stabilised albumin molecule and make it resistant to heat. When the plasma bag was heated, other plasma proteins are irreversibly precipitated and can be separated by centrifugation. Finally, albumin is filtered and pasteurized in plasma bag. The purity of prepared albumin is >99% and the yield is 21 g per liter of plasma. Polymer content of pasteurized albumin measuring with High Performance Liquid Chromatography (HPLC) was less than 1%. Since albumin preparation in plasma bag is a simple and cheap technology, it has the potential for use in the production of a safe plasma derived product, although suitability for human use would require appropriate clinical assessment for safety. Using this method, albumin could be prepared from all types of plasma. This method is suggested as a possible method of albumin production for all countries which do not have a plasma fractionation industry and even for the countries with low plasma supplies.

Improved BC method of Compomat G4 for expression of BCs twice from whole blood in top and top bags

The aim of this paper was to evaluate an improved buffy coat (BC) method of Compomat G4 for automated expression of BCs twice from whole blood (WB) in top and top (T&T) bags. WB was separated using hard spin centrifugation (2,988g, 10 min) into layers of blood components by specific gravity, and different components were subsequently expressed into satellite bags in the T&T system using the manual BC method, the conventional BC method of G4, and our improved BC method of G4. In the improved BC method, an accessorial device we have named a 'gravity press' was designed and installed on the top flat of G4 to produce gravitational pressure on the plasma bag so as to exclude air and some of plasma to the upper compartment of the slide after BCs were expressed for the first time. The residual BCs in the upper compartment were expressed a second time by extending the upper press once more. All of the pooled BCs were centrifuged by soft spin (402g, 10 min) and upper platelet-rich supernatant was manually expressed into a platelet container by the plasma extractor. In vitro studies of blood components and pooled platelet concentrates (PCs) revealed no significant differences in BC blood components and platelet recovery of pooled platelets (61 ± 9 vs. 60 ± 7%, n = 12, p > 0.05) between the improved BC method and the conventional BC method; all components met our specifications for blood products. We suggest that the new BC method for use of T&T bags may improve the collection of BCs.

Volume Reduction in Routine Cord Blood Banking

Umbilical cord blood (UCB) is an alternative source of hematopoietic progenitors for transplantation in the treatment of haematological malignancies, marrow failure, immunodeficiencies, hemoglobinopathies and inherited metabolic diseases. It has greatly contributed to increase the feasibility to transplantation for many patients in need. To date, more than 20,000 UCB transplants have been performed on children and adults, and more than 400,000 UCB units are available in more than 50 public CB banks. One of the most important objectives of banks is to cryopreserve and store high quality UCB units. Volume reduction is a usual process in cord blood banking that has some advantages as reducing the storage space and the DMSO quantity in final product. Volume reduction methodology must guarantee high cell recovery and red blood cell (RBC) depletion by reducing the UCB units to a standard volume. Hydroxyethyl starch (HES) sedimentation was the first method developed for this purpose by the New York Cord Blood Bank and implemented in many banks worldwide. The semi-automated top and bottom system, usually used for blood fractionation was further developed to simplify and short the process. Later, automatic devices as SEPAX and AXP have been developed in last years specifically for UCB volume reduction purpose. This review critically analyses the advantages and disadvantages of the different procedures. All of them have been used in Valencia Cord Blood Bank along 10 years. In general, automatic devices are preferred because of compliance with cGTP, closed systems, higher reproducibility and less influence of technician.

One‐year experience of nucleic acid technology testing for human immunodeficiency virus Type 1, hepatitis C virus, and hepatitis B virus in Thai blood donations

Blood donations collected at the National Blood Center, the Thai Red Cross Society, Bangkok, in 2007 were tested by nucleic acid amplification technology (NAT) using the Chiron TIGRIS/Procleix Ultrio test and the Roche cobas s 201/cobas TaqScreen multiplex (MPX) test. The sensitivity, specificity, and robustness were determined by testing 486,676 seronegative blood donations. Samples from each day of collection were divided into two sets; the odd-numbered samples were tested individually on the TIGRIS and the even-numbered samples were tested in pools of 6 on the cobas s 201. The status of reactive samples was confirmed by duplicate testing of samples from the plasma bag to calculate the test specificity. Reactive samples were tested on the alternate system and followed up. The analytical sensitivity of both systems met the 95% limits of detection claimed by the respective package inserts. No cross contamination was seen with either system. Test specificity was 99.93 and 99.90% for the Procleix Ultrio and cobas TaqScreen tests, respectively. The NAT yield rates for human immunodeficiency virus Type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) were 1:97,000, 1:490,000, and 1:2800, respectively. Several occult HBV donors, the majority of whom were detected by both tests, were also identified. The HIV-1 and HCV window cases were detected with both tests. The performances of the systems and tests indicated that both were acceptable for routine NAT by the National Blood Center, the Thai Red Cross Society. However, the Procleix Ultrio test appeared to be less sensitive than the cobas TaqScreen test for HBV.

A potentially improved approach to methylene blue virus inactivation of plasma: the Maco Pharma Maco-Tronic system.

Plasma was subjected to methylene blue (MB) photochemical virus inactivation using the Maco Pharma Maco-Tronic system which allows three units to be illuminated together, thus reducing processing time. The plasma bag system used incorporates an integral membrane plasma filter and a dry MB pill which dissolves in the plasma to give a 1-microM concentration. There is computer-controlled processing and datalogging. In an assessment of 10 pools of Group A plasma, the losses of coagulation factors, following MB/light treatment, were 23% fibrinogen, 10% FV, 26% FVIII, 11% FIX and 13% FXI. Group O, Group B and Group AB plasmas were not tested. Von Willebrand factor (vWf) multimers showed no substantial change when treated with MB, and no losses were seen for antithrombin III (ATIII), protein C and vWf:Ag. Measurements of C3a, C5a, prothrombin fragment 1+2 and FXIIa indicated that there was no activation as a result of filtration.

Aluminium bone disease in patients receiving plasma exchange with contaminated albumin.

Aluminium balance studies were carried out on eight patients with various immunological disorders who were receiving plasma exchange with albumin solutions known to be contaminated with aluminium. Four patients with impaired renal function (creatinine clearance less than 50 ml/min) retained between 60% and 74% of the aluminium infused during a single plasma exchange. Transiliac bone biopsy specimens from three patients in this group had a high content of aluminium and showed histological evidence of current or previous bone disease related to aluminium. Two of these patients suffered intermittent bone pain. The main route of excretion of injected aluminium was in urine, only a small proportion of the total input being removed in the "plasma bag" during plasma exchange. The extent of aluminium retention and bone deposition was not reflected by the plasma aluminium concentration before or after plasma exchange. Treatment of five patients with intravenous desferrioxamine increased the plasma aluminium concentration and urinary output of aluminium in those with evidence of aluminium retention. These studies show that patients with poor renal function receiving treatment with albumin contaminated with aluminium retain the metal and deposit it in bone, where it may eventually cause aluminium bone disease. Plasma exchange should be used with caution in patients with renal impairment.

Rapid controlled thawing of fresh‐frozen plasma in a modified microwave oven

A microwave oven has been specifically modified to permit rapid thawing of fresh-frozen plasma (FFP) by using a rotating disc with a temperature sensor to hold the plasma bag. This modification makes it possible to mix the FFP continuously during thawing, and automatically shuts the oven off when the plasma reaches 21 degrees C. Comparisons were made between FFP thawed in the modified microwave oven and FFP thawed conventionally in a 37 degrees C waterbath. The following tests were done: total protein, albumin, and immunoglobulin concentrations; plasma fibrinogen, factor VIII, and factor IX activities; protein electrophoresis, albumin aggregation, hemolytic complement activity, and plasma particle count and size. In no case was there a significant difference between plasma thawed in the microwave oven compared with that thawed in the waterbath. Further, microwave thawing was reliable and rapid; all units of FFP thawed in less than 6 minutes, and the thawed plasma did not vary by more than 6 degrees C from the preselected final temperature of 21 degrees C. Thus, it appears that controlled thawing of FFP in a microwave oven specifically designed for this purpose is an effective and reliable method and has many advantages over conventional thawing of FFP.

A simple method for the preparation of microaggregate-poor whole blood.

Microaggregate-poor whole blood is prepared by collecting blood in ordinary double or triple plastic bag systems, separating cell-poor plasma and buffy coat from the red cells but without disconnecting the plasma bag and the red cell bag from each other. The double unit is stored at refrigerator temperature. After 10 days' storage, the tube connecting the two parts of the double unit can be sealed upon which further storage is done separately. In this way all whole blood units in stock will have both a low content of microaggregates and a normal or nearly normal affinity for oxygen.

A Simple Method for the Preparation of Microaggregate-Poor Whole Blood

Microaggregate-poor whole blood is prepared by collecting blood in ordinary double or triple plastic bag systems, separating cell-poor plasma and buffy coat from the red cells but without disconnecting the plasma bag and the red cell bag from each other. The double unit is stored at refrigerator temperature. After 10 days’ storage, the tube connecting the two parts of the double unit can be sealed upon which further storage is done separately. In this way all whole blood units in stock will have both a low content of microaggregates and a normal or nearly normal affinity for oxygen.