|Study Number||Study Version||Year Started||Study Title||Study Description||Study Status||Publication Number||Study Leaders||Teams|
|113|| ||2017||Haemoglobin screening and deferral policies|| ||Active|| ||Di Angelantonio, van den Hurk||DS|
|112|| ||2017||Older donors study|| ||Active|| ||Goldman||DS|
|111|| ||2017||Pediatric Transfusion Medicine Education|| ||Active|| ||Haspel, Fung||CTS|
|110|| ||2017||Titer Products for SafetY: TIPSY||Minor incompatible platelet transfusions are common practice, yet plasma has historically been provided in a strictly ABO compatible manner. However, transfusions of group A plasma and group O whole blood to recipients of unknown blood group in emergencies are becoming common and are situations where minor incompatible plasma might be transfused.
Blood products with high titer anti-A and/or anti-B have a greater risk of causing hemolysis in a recipient with the corresponding A and/or B antigen. Currently, there are no universally accepted standards for the method of performing the titer testing or for the definition of a “high” titer antibody. Between blood banks, various titer methods are used and different thresholds are used to designate “high” titer units. The goal of this study is to capture the titer testing methods for plasma, single donor platelet (SDP), and whole blood units and to elucidate the prevalence of “high” titer units using the local definitions.
1. What are the various titer testing methods used for plasma, SDP and whole blood units?
2. What is the prevalence of high titer units by donor blood group (i.e. what is the high titer failure rate by donor blood group)?
3. Is there seasonal, or month to month variation in the frequency of detecting high titer units?||Active|| ||Dunbar, Harm, Yazer||CTS|
|109|| ||2017||Effect of Having a Surgical RBC Schedule on the General Availability of rbcs pre-Incision: EHSS GAI|| ||Active|| ||Yazer, Cohn||CTS|
|108|| ||2017||Critical values List for Blood Bankers|| ||Active|| ||Shaz||CTS|
|107|| ||2017||Better Understanding of Mfi cut-offs for Platelet Transfusions in Refractory Patients: BUMPER|| ||Active|| ||Cohn||CTS|
|106|| ||2017||Oneg Product Transfusion, Inventory Management and Utilization during Shortage: OPTIMUS||The goal of this study is to determine how utilization of ONEG RBC units can be reduced using various switching rules. This will be a pragmatic, retrospective descriptive study using actual transfusion data from your site. The intention of this study is to determine how many ONEG RBC units could be saved, for example, by lowering the automatic switching age to facilitate decision making during times of shortage in a graded manner, e.g., if the ONEG inventory needs to be increased by 10% during a shortage, perhaps the switching age needs to be lowered by 5 years, if a 20% increase is required perhaps a 10 year reduction is temporarily needed until the inventory returns to its usual level.||Active|| ||Dunbar, Yazer||CTS|
|105|| ||2017||Surveys in Transfusion|| ||Active|| ||Stanworth||CTS|
|104|| ||2017||Platelet additive storage lesion mitigation induced by pathogen reduction|| ||Active|| ||van der Meer||CC|
|103|| ||2017||Autologous Platelet Rich Plasma (aPRP) Survey||Autologous platelet rich plasma (aPRP) is widely used by orthopedic surgeons for chronic ‘wear and tear’ injuries, and by general surgeons for hastening wound and incision closures. Autologous PRP is often manufactured at the bedside in outpatient clinics, and in the operating theater. In the United States the FDA has approved the devices used to isolate aPRP, but has left the application of aPRP to the non-regulated area of ‘scope of medical practice.’ As a result the quality of the aPRP and its applications are not regulated. Studies have found that many of the aPRP isolation kits give highly irregular yields, with little enrichment of the platelet-rich-plasma fraction. Quality control efforts by orthopedic surgeons and other users are not known.
The current range of aPRP usage is not easily assessed. We have developed a survey to discover whether aPRP is used in BEST member hospitals, and whether the Blood Bank is involved in quality control measures.||Active|| ||Cohn||CC|
|102|| ||2017||Multicenter study on essentials for novel cellular therapy products manufacturing practices||At the frontier of Transfusion Medicine and Transplantation the field of Cellular Therapy is emerging. Most Novel cellular therapy products are produced under IND. The manufacturing protocols may vary depending on the type of cellular product (e.g. mesenchymal stromal cell, pancreatic islet, natural killer cells, or T regulatory lymphocytes…). Interestingly, the manufacturing practices may also vary with the institution under which the investigative protocol is filed.
The purpose of this study is to uncover the variations in manufacturing practices for similar cellular therapy products across different Cellular Processing Laboratories in institutions worldwide.
The results of this survey may allow the identification of the essentials of manufacturing practices to be recommended for specific cellular therapy products at different stages of manufacturing (i.e. collection, ex vivo manipulation or expansion, distribution, or preparation for infusion). ||Active|| ||Fontaine||CT|
|101|| ||2016||Effect of Blood Donation on Elevated Blood Pressure|| ||Active|| ||Greinacher||DS|
|100|| ||2016||Longitudinal OBservational revieW of Ethnic Donors Giving Erythrocytes: LOB Wedge|| ||Completed||106, 109||Yazer||DS|
|99|| ||2016||WARM 2: RBC Selection Practices|| ||Active|| ||Ziman, Delaney||CTS|
|98|| ||2016||Inventory of Committee Evaluated Hospital Quality Indicators - ICE HoQuI|| ||Completed||107||Yazer||CTS|
|97|| ||2016||Informed Consent in Blood Transfusion|| ||Active|| ||Fung, Haspel, Zeller||CTS|
|96|| ||2016||Empiric use of 4 factor PCCs with life-threatening bleeds|| ||Active|| ||Gorlin||CTS|
|95|| ||2016||Determining Workload Capacity of CT Processing Laboratory||Assessing the day-to-day capacity for the SCL is challenging yet necessary to ensure patient safety, staff well-being/retainment and ultimately, sustained productivity. Moreover, SCLs are often requested to justify resource utilization and budgeting requests in the context of other comparable HSC laboratories. However, standards on how to determine daily/weekly operational capacity and benchmark data for the industry are not readily available. Some unique aspects of SCL operations which make comparing one laboratory to another are wide variation in hands-on-time required for various procedures (e.g. numbers of allogeneic cord blood/bone marrow/apheresis products requiring red cell reduction vs. unmanipulated or autologous products) and the availability of automation. In addition, the scope of practice (e.g. whether SCL staff are present at collection site and/or perform bedside thawing) also varies. In addition, SCLs differ from other clinical labs in varying availability of software to manage testing, reporting, and integration of patient data. To address these gaps we undertook time studies of ~20 common procedures/tasks in three distinct but large academic transplant programs using manual processing. Staff were instructed to time actual hands-on time spent performing tasks, including necessary paperwork/data entry (Table 1). Tasks such as infusion of cryopreserved products and preparation of HPC for shipping required significant time investment commensurate with HPC processing. Also DLI product manipulations take significant time. Since, many SCL laboratories are not involved in product infusions or do not serve as NMDP sites, inclusion of these activities would significantly alter transplant volume capacity per FTE. ||Active|| ||Young||CT|
|94|| ||2016||Trends for Collections|| ||Completed||97|| ||DS|
|93|| ||2015|| Evidence-Based Guidance for Donor Reaction Management|| ||Active|| ||Vassallo||DS|
|92|| ||2015||ABOut HLA|| ||Completed||98||Dunbar||DS|
|91|| ||2015||Resuspension of Cryopreserved Platelets in PAS|| ||Active|| ||Dumont, Johnson||CC|
|90|| ||2015||Interlaboratory Measurements of Cryopreserved Platelets|| ||Active|| ||Noorman, Johnson||CC|
|89|| ||2015||Will Issue:Crossmatch ratio Keep Erythrocytes Tight -WICKET|| ||Completed||101||Yazer, Ziman||CTS|
|88|| ||2015||How many AB unitS Were Infused - HABS WIN|| ||Active|| ||Yazer||CTS|
|87|| ||2015||Safety of Thawed A in Trauma - STAT||To better understand the current use of plasma in trauma resuscitation, a survey was developed, validated, and distributed via e-mail to 121 American trauma centers.||Active||89||Yazer, Dunbar||CTS|
|86|| ||2015||GRoup O Utilization Patterns - GROUP|| ||Completed||publication accepted||Yazer||CTS|
|85|| ||2015||Blood Collection and Processing Methods for Serum Eye Drops|| ||Completed||108||Irving, Marks||CC|
|84|| ||2014||Ultra-Massive Transfusion|| ||Completed||92||Dzik, Yazer||CTS|
|83|| ||2014||Hemolysis Measurement Standardization|| ||Active||105||Acker||CC|
|82|| ||2014||Survey for Component Transformation|| ||Active-Manuscript in Preparation|| ||Cardigan||CC|
|81|| ||2014||Dendritic Cells and Function||Dendritic cells can be manufactured using different methods and starting cellular material.
Two methods of DC isolation and culture will be evaluated, immunomagnetic separation and elutriation for monocyte enrichment. ||Active|| ||Garritsen||CT|
|80|| ||2014||MSCs: Inter-laboratory variability||Because of their reparative, immunomodulatory and angiogenic potential, autologous and allogeneic human mesenchymal stem cells (hMSCs) are produced in cultures for a wide variety of clinical applications. However, there is a lack of standardized methodologies to culture human MSCs and it is unknown as to what the impact of different laboratories strategies have on the function of cultured derived hMSCs.
To assess inter-laboratory variability associated with culturing hMSC, 3-4 different laboratories will receive three different bone marrows from the same source and culture the hMSC using their own laboratory methodologies. At passages 1, 2, and 3, viable cell counts will be performed and the fold-increases and doubling times will be determined. At the end of passage number #3, immunophenotyping will also be performed and harvested cells will be sent for microarray analysis.
The purpose of this study is to assess the inter-laboratory variability associated with producing hMSCs by different laboratories using the same starting source of hMSC and each laboratory using its own culture conditions.
The following characteristics will be evaluated a cell count and minimally immunophenotype for the following markers: CD105, CD73, CD90, CD34, CD45, CD14. In addition, cells will be analyzed for gene expression at NIH.||Manuscript in Preparation|| ||Reems, Stroncek||CT|
|79|| ||2014||Transfusion Reaction Guidelines|| ||Active|| ||Delaney, Ziman||CTS|
|78|| ||2014||DARA-DTT Study|| ||Active||95, 100||Kaufman||CTS|
|77|| ||2014||An International Study of Donor Demographic Trends||This study will compare and interpret donor and general population age trends in 3 years (2001, 2006 & 2011) amongst blood collectors in various jurisdictions to hypothesize about differing social values and donor motivations as well as identify successful past and future blood center donor selection, recruitment & retention practices.||Active|| ||Goldman||DS|
|76|| ||2014||A Case-Control Study of Donor Factors Associated with Unacceptably Low pH in Stored Apheresis Platelets||Using participant QC data, this study will attempt to identify medical & demographic donor characteristics potentially associated with an increased risk of poor platelet storage, as reflected by unexplained low pH at unit issue or outdate.||Completed||104||Germain||DS|
|75|| ||2013||D sensitization after platelet transfusion: ADAPT|| ||Completed||88||Cid||TS|
|74|| ||2013||Irradiation of Red Cells|| ||Active-Manuscript in Preparation|| ||de Korte, Cardigan, Devine||CC|
|73|| ||2013||Influencing Plasma uSage With Information that is Computerized and Helpful: IPSWICH|| ||Closed|| ||Yazer, Brooks||CTS|
|72|| ||2013||Warm Autoimmune Hemolytic Anemia: Testing and Transfusion Practices|| ||Completed||99||Ziman||CTS|
|71|| ||2013||Survey to identify release criteria being utilized with cellular therapy products-revisted|| ||Active|| ||Szczepiorkowski||CT|
|70|| ||2012||Comparison of MSC Manufactured at Different Centers||Mesenchymal Stem Cells are widely used in clinical trials. They are manufactured in different centers with variable conditions including donor, source of starting material, culture conditions etc. Their use and release criteria are also variable.
The focus of this study is to answer the following questions:
1. Describe differences in BMSC manufacturing among centers
2. Identify differences, if any, due to manufacturing on product quality
3. Identify the most important sources of variability
Each participating site provides several samples for analysis. The evaluation will include descriptive characteristics (e.g. starting material, methods, surface marker expression etc); as well as gene expression analysis. Additional studies will include murine transplantation studies with assessment of in vivo bone and cartilage formation and support of hematopoiesis||Completed||111||Stroncek||CT|
|69|| ||2012||Low Level Platelet & Red Cell Counting Send-around|| ||Active|| ||van der Meer, Blair||CS|
|68|| ||2012||Preventing HDFN with Transfusion Matching of Females of Childbearing Potential - AMIGO|| ||Completed||102||Delaney||CTS|
|67|| ||2012||Development of a standardized case report form for bleeding assessment in clinical trials|| ||Active|| || ||CTS|
|66|| ||2012||Viability Testing in Cryopreserved Thawed CT Products|| ||Active|| ||Takanashi||CT|
|65|| ||2012||Viability and Functional Evaluation of Cryopreservation Methods for T cell Populations||Peripheral blood mononuclear cells (PBMNC) collected from leukaphereses of allogeneic hematopoietic stem cell (HSC) donors are often given to the transplantation recipients as prophylactic or therapeutic immunomodulatory therapy. This product has been generically named donor-derived leukocyte infusion (DLI).
For decades, the reference cryoprotectant for these products was 10% DMSO. However, several studies on HSC engraftment have indicated that combinations of 4-5% DMSO and hydroxyethylstarch provide similar (or even better) post-thaw viability/function. Whether the functional response of different T-cell populations is similar or not is unknown.
1. Cryopreservation may induce significant T-cell viability and functional defects which may differ for different T cell populations.
2. Different T cell populations may differ in their optimal cryopreservation medium requirements.
In the participating sites the apheresis product will be collected and cryopreserved in different cryopreservation solutions (DMSO 5%; 10%; CryoStor 5% and CryoStor 10%). Fresh and cryopreserved cells will be shipped to the central laboratory (Univ of Cincinnati).
The analysis will include testing for immunophenotype, viability, proliferation and cytokine release.||Completed||110||Cancelas||CT|
|64|| ||2012||Collection and Storage Solutions for CT Products|| ||Active|| ||Haspel||CT|
|63|| ||2011||TOFU: Trial of feedback on blood use|| ||Active|| ||Kaufman, Yazer, Stanworth||TS|
|62|| ||2011||Counting platelets in thrombocytopenic samples|| ||Completed||85||Lozano||CS|
|61|| ||2011||Anemia prior to surgery|| ||Closed|| ||Waters||CTS|
|60|| ||2010||Intracellular vs extracellular cryopreservation agent|| ||Active|| ||Mathew||CT|
|59|| ||2010||Critical appraisal of tools used to capture bleeding in clinical trials|| ||Active|| ||Stanworth||CTS|
|58|| ||2010||Activation markers in platelets|| ||Completed||83||Devine||CC|
|57|| ||2010||Standardisation of red cell biochemical assays|| ||Completed||80||Hess||CC|
|56|| ||2010||Clinical description of transfusion reactions|| ||Withdrawn|| || ||TS|
|55|| ||2009||What do physicians know about transfusing|| ||Completed||84, 86, 91, 93||Haspel||TS|
|54|| ||2009||Age of Blood Studies: Methodological Pitfalls|| ||Completed||65||van de Watering||CS|
|53|| ||2009||Survey of Repetitive Stress Injury and Contact Dermatitis|| ||Withdrawn|| || ||CS|
|52|| ||2009||TM Assistant: a programe for differential diagnosis of acute transfusion reactions|| ||Closed|| ||Heddle||CTS|
|51|| ||2008||Platelet quality after different pre processing hold conditions|| ||Completed||73||de Wildt||CC|
|50|| ||2008||Haemolysis from national quality control data|| ||Completed||58||Hess||CC|
|49|| ||2008||Nucleotide profiles in red cells relative to R&S|| ||Active|| ||Dumont||CC|
|48|| ||2008||Bacterial contamination of CT products|| ||Withdrawn|| || ||CT|
|47|| ||2008||Transportation of CT products|| ||Completed||64||McKenna, Pamphilon||CT|
|47||B||2010||Optimal Transport Conditions for Non-Mobilized Apheresis Collections|| ||Active|| ||McKenna||CT|
|46|| ||2007||Modelling effect of shortening red cell life on inventory|| ||Completed||83||Beckman||TS|
|45||B||2007||Guidelines for reporting platelet trials in transfusion medicine: Phase 2 – Delphi technique|| ||Completed||79||Heddle||CS, TS|
|45||A||2007||Guidelines for reporting platelet trials in transfusion medicine: Phase 1 – Young investigators|| ||Completed||61||Heddle||CS, TS|
|44|| ||2007||Questionnaire on ABO incompatible platelets|| ||Completed||59||Lozano||CS|
|43|| ||2007||Haemoglobin measurement of blood units matched to patients|| ||Completed||62||Hervig||CS|
|42|| ||2006||Qualitative Evaluation for Safer Transfusion (QUEST)|| ||Completed||78||Heddle||TS|
|41|| ||2006||Whole blood overnight storage|| ||Completed||66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76|| ||CC|
|40|| ||2006||Reduction in variation of performance of antibody titrations|| ||Completed||55||AuBuchon||CC|
|39|| ||2006||Survey of transfusion utilization methods|| ||Active-Manuscript in Preparation|| ||Tinmouth, Stanworth||TS|
|38|| ||2006||Statistical process control for blood sample collection|| ||Completed||54||Beckman||TS|
|37|| ||2006||Comparison of single- and double-label approaches to red cell recovery studies and evaluation criteria|| ||Completed||53||Dumont, AuBuchon||CS|
|36|| ||2005||Functional assays for evaluation of dendritic cells|| ||Closed||4||Eichler, Szczepiorkowski||CT|
|35|| ||2004||Platelet quality control standardization send-around|| ||Completed||77||van der Meer, Cardigan||CC|
|34|| ||2004||Bacterial contamination detection questionnaire|| ||Completed||52||Prowse|| |
|33|| ||2004||Comparison of radiolabeling and flow cytometry for determining platelet kinetics|| ||Active-Manuscript in Preparation|| ||van der Meer, Slichter||CTS|
|32|| ||2006||Standardisation of the CFU assay|| ||Completed||82||Reems||CT|
|31|| ||2003||Randomized controlled trial of a simple intervention to improve performance of the pretransfusion bedside identity check (PROBE Study)|| ||Completed||49||Murphy||TS|
|30|| ||2003||Survey to understand cell recovery in thawed cord blood samples|| ||Completed||51||Brand||CT|
|29||A||2003||Survey to identify release criteria being utilized with cellular therapy products|| ||Closed|| ||Szczepiorkowski||CT|
|29||B||2003||Transportation/shipping survey|| ||Completed||60||Pamphilon||CT|
|28|| ||2003||Inter-lab pilot study on the quality characteristics of dendritic cells|| ||Completed||50||Eichler||CT|
|27|| ||2003||A descriptive analysis of international transfusion practice and bleeding outcomes in patients with acute leukemia|| ||Completed||40||Heddle||CS|
|26|| ||2003||Comparison of in vitro analyses of red cell units across multiple labs|| ||Completed||37||Hess||CC|
|25|| ||2003||Comparison of Recovery and Survival of Extended Storage PRP and Buffy Coat Platelets in Health Volunteers|| ||Completed||63||Dumont||CS|
|24|| ||2003||Effect of two days’ shipping on platelet function and biochemical analyses|| ||Completed||35||Dumont, Gulliksson||CC|
|23|| ||2003||Effect of supranormal pH on radiolabeled platelet recovery and survival|| ||Completed||38||Dumont, Gulliksson||CS|
|22|| ||2002||Evaluation of the hemostatis efficacy and the platelet utilization rates of low versus standard dose platelet therapy (SToP)|| ||Completed||26, 29, 31|| ||CS|
|21|| ||2002||Effect of storage medium and protein source on ESC and HSR|| ||Completed||30|| ||CC|
|21||A||2001||Effect of storage medium and protein source on ESC and HSR (pilot study) || ||Completed||24|| ||CC|
|20|| ||2001||Effects of interruption of agitation of platelet concentrates stored in PAS environment (pilot study)|| ||Completed||32|| ||CC|
|19||A-F||2001||Evaluation of in vitro asay utilized to evaluate cord blood hemopoietic stem cell products|| ||Completed||33, 39|| ||CT|
|18|| ||2001||The COBS (collection of blood samples) study|| ||Completed||25, 27|| ||CT|
|17|| ||2001||Storage of platelets in additive solutions: In vitro effects of potassium and magnesium (pilot study)|| ||Completed||22, 23|| ||CC|
|17||A||2000||Storage of platelets in additive solutions: In vitro effects of potassium and magnesium (pilot study)|| ||Completed||21|| ||CC|
|16|| || ||Evaluation of the influence of conditions encountered during the transportation of platelet components from blood centers to hospitals on platelet quality (See Study 20)|| ||Closed|| || ||CC|
|15|| ||1999||Cord blood filtration study|| ||Completed||41|| ||CT|
|14||B|| ||SToP: Analysis of adjudication process|| ||Completed||96|| ||CS|
|14||A|| ||SToP Main study|| ||Completed||57|| ||CS|
|13|| ||1996||CD34+ cell count|| ||Completed||18|| ||CT|
|12|| ||1996||Platelet counting study|| ||Completed||15, 20, 36|| ||CC|
|11|| ||1996||Automated white cell count in white cell reduced blood components|| ||Completed||19|| ||CC|
|10|| ||1996||Platelet transfusion in routine practice|| ||Closed|| || || |
|9|| ||1996||In vitro assays for evaluation of the properties of stored platelets: interlaboratory study to evaluate lactate, lactate dehydrogenase and CD62 parameters|| ||Completed||16|| || |
|8|| ||1995||Multicenter evaluation of the 3% PFA method for white cell counting in leukocyte-reduced red blood cells|| ||Completed||11|| || |
|7|| ||1994||Use of in vitro assays: evaluation of platelet properties using the extent of shape change, and response to hypotonic stress assays|| ||Completed||14|| || |
|6|| ||1994||Cellular harvests in blood components prepared with buffy-coat removal versus methods based on platelet-rich plasma|| ||Completed||6, 7, 13|| || |
|5|| ||1994||Relation between swirling and other methods for PC quality control|| ||Completed||4, 5|| || |
|4|| ||1994||Evaluation of platelet swirling vs pH in routine PC|| ||Completed||9|| || |
|3|| ||1993||Quality control of platelet concentrates by shimmering inspection|| ||Completed||2, 4|| || |
|2|| ||1992||Counting leukocytes by Nageotte chamber in leukocyte-depleted red blood cells|| ||Completed||3, 10|| || |
|1|| ||1991||Flow cytometry vs Nageotte chamber white cell counting methods|| ||Completed||1|| || |