The results of our study support the need for the continued use of prophylaxis with platelet transfusion and show the benefit of such prophylaxis for reducing bleeding, as compared with no prophylaxis. A significant number of patients had bleeding despite prophylaxis. (Funded by the National Health Service Blood and Transplant Research and Development Committee and the Australian Red Cross Blood Service; TOPPS Controlled-Trials.com number, ISRCTN08758735.).

1 Background The effectiveness of prophylactic platelets (plts) to prevent bleeding in patients with hematological malignancies remains unclear. The aim of this trial was to test the hypothesis that a policy of no-prophylactic plt transfusions (PltTx) is as effective and safe as a policy of prophylactic PltTx. Methods TOPPS was a randomized, parallel group, open-label, non-inferiority trial that recruited from 14 UK and Australian hospitals (ISRCTN08758735). The primary outcome was proportion of patients with a clinically significant bleed, defined as ≥WHO Grade 2, up to 30 days (d) from randomization. Non-inferiority margin was defined as a 15% difference in proportion of patients experiencing the primary outcome. Adult patients were eligible if they had a hematological malignancy, were receiving chemotherapy or stem cell transplant (SCT) and expected to be thrombocytopenic for at least 5 days. Patients were randomized by centralized computer system to receive either prophylactic PltTx if plt count was <10×109/L, or no prophylaxis. Allocated treatment policy applied for 30d from randomization, irrespective of in- or out-patient status. In both arms PltTx were given therapeutically (documented signs or symptoms of bleeding) or prior to invasive procedures or at physician discretion. Analysis was by intention to treat. Results Recruitment began August 2006 and closed in August 2011. Of 1093 patients screened, 600 patients were randomized (301 no-prophylaxis, 299 prophylaxis). Baseline characteristics were well matched. 70% patients in both arms received autologous SCT (autoSCT). The majority of patients in both arms had complete bleeding data recorded [median 30d (IQR 29 to 30) no-prophylaxis arm, median 30d (IQR 30 to 30) prophylaxis arm]. Two patients (1 in each arm) withdrew prior to any data collection. Most PltTx in both arms were given according to protocol (no-prophylaxis 450/504 (89%) vs prophylaxis 810/894 (91%). Fewer patients in the no-prophylaxis group received PltTx (176/300, 59%) vs. prophylaxis group (266/298, 89%) [OR 0.14 (95% CI 0.09 to 0.23]; and they also received fewer PltTx overall [no-prophylaxis mean 1.7 PltTx (SD 2.6) vs. prophylaxis mean 3.0 PltTxs (SD 3.2); rate ratio 0.62, 95% CI 0.51 to 0.74]. Average number of days with plt count <10 and <20×109/L was significantly longer in no-prophylaxis arm. A WHO grade 2–4 bleed occurred in 151/300 patients (50%) in the no-prophylaxis group compared to 128/298 (43%) in the prophylaxis group (adjusted difference in proportions 8.4%, 90% CI 1.7 to 15.2%: p-value for non-inferiority 0.06). This study therefore did not prove its main aim, that a no-prophylaxis policy is non-inferior to prophylaxis. The time to the first grade 2–4 bleed was significantly shorter in the no-prophylaxis group (Fig. 1). Patients in the no-prophylaxis group averaged 1.7d (SD 2.9) with a WHO grade 2–4 bleed during follow-up, vs. 1.2d (SD 2.0) in the prophylactic group [rate ratio 1.52, 95% CI 1.14 to 2.03]. Whilst there were more grade 3–4 bleeds in the no-prophylaxis group (6/300) compared to the prophylaxis group (1/298) this did not reach statistical significance (OR 6.05, 95% CI 0.73 to 279.72, p = 0.13). Only 2 of these 7 patients had a plt count <10×109/L at onset of grade 3–4 bleeding (median plt count 16, range 3–42 x109/L); both patients were receiving induction chemotherapy for AML. Pre-defined subgroup analysis between autoSCT vs other treatments for the primary outcome found a significant interaction (p-value 0.04). In the autoSCT group, WHO grade 2–4 bleed grade occurred in 99/210 patients (47%) in the no-prophylaxis group vs 95/210 (45%) in the prophylaxis group (difference in proportions 2.3%, 90% CI −5.7 to 10.3%). For all patients, there was no significant difference between treatment groups in period of thrombocytopenia, number of days in hospital, or number of SAEsexperienced. Discussion This multicenter study has not shown that a no-prophylaxis PltTx policy is non-inferior to prophylaxis. Patients in the no-prophylaxis group had more days with a WHO grade 2 or above bleed, and a shorter time to first bleed. Further analysis is needed to determine whether these findings apply to all subgroups of patients. Despite a role for prophylactic platelet transfusions, rates of bleeding in patients remain high. Funding NHS Blood and Transplant & Australian Red Cross Blood Service Disclosures: No relevant conflicts of interest to declare.

Patient blood management (PBM) is a widely established international initiative, with a multidisciplinary approach to reduce transfusion. The Transfusion Practitioner (TP) role is well embedded in the United Kingdom (UK) and Australia. The value of the TP in changing both culture and practice to implement an all-inclusive PBM approach to care will be discussed. The TP role was born from both a safety and haemovigilance culture, where the greatest identified risk to the patient undergoing a transfusion was human error. From this initial trigger for improved safety, the TP role has evolved to a multifaceted, highly specialised role, involved in both PBM and transfusion processes. As the transfusion paradigm shifted from product to patient, the TP role evolved to include PBM, with an emphasis on the patients and the impact transfusion has on them. A multidisciplinary team is required to drive both PBM and transfusion; the TP is recognised as a critical link in the multidisciplinary team. They are seen as a driving force for change, bridging the gap between the laboratory and clinical arenas. The TP plays a vital role in helping establish and embed PBM that improves patient and safety outcomes.

No abstract

Background The 2001 National Health and Medical Research Council/Australasian Society of Blood Transfusion Clinical Practice Guidelines for cryoprecipitate are being updated, and cryoprecipitate has been incorporated into new Patient Blood Management modules. Aims This clinical audit sought to clarify current cryoprecipitate use in Victoria, Tasmania and the Australian Capital Territory; assess adherence to guidelines; and gain insights into deviations from recommended practice. This information can be utilised in updating guidelines to make them more relevant, to identify areas for clinician education and to form a baseline of practice prior to release of the 2011 guidelines. Methods Participating institutions were invited to audit up to 30 consecutive episodes of cryoprecipitate transfusion over an 11‐month period in 2008. The audits were conducted using a standardised pro forma and involved review of patient records. These were collated electronically using algorithms to determine alignment versus non‐alignment with guidelines. Results Cryoprecipitate is used in a variety of situations with surgery accounting for the highest volume. Twenty‐six per cent (26%) of transfusions were aligned with 2001 guidelines rising to 61% with a modified fibrinogen trigger. Fibrinogen levels did not appear to dictate all clinical decisions regarding cryoprecipitate use perhaps owing to the acuity of many cases. Additional bleeding risk together with low fibrinogen levels (e.g. thrombocytopenic patients) may contribute to empiric cryoprecipitate use. Conclusions These results highlight discrepancies between guidelines and practice, providing rationale for the update of the guidelines that is currently underway. Cryoprecipitate has attendant risks, and it is appropriate that transfusion be restricted to situations with good evidence or sound principles to underpin use.

Transfusion safety coordinators (TSCs) are an integral part of the transfusion process, which involves many interlinking chains of events and a multidisciplinary group of health professionals. In Australia, individual hospital‐based TSCs have been in place for several decades, with state‐based collaboratives commencing in 2002. The role has expanded across the country and currently there are 113 dedicated TSC positions and many more staff involved as blood/transfusion champions. There are also 12 transfusion nurse (TN) positions within the Australian Red Cross Blood Service. Over time both TSC and TN roles have evolved to meet the changes within the Australian blood sector. The primary focus of safety and appropriateness has now evolved to be more patient‐centred by incorporating patient blood management (PBM) initiatives. National PBM guidelines, statements, strategies, criteria and healthcare standards specifically focused on all aspects of transfusion have influenced this evolution. TSCs undertake diverse roles and activities that vary significantly between health services and within each jurisdiction. Effective communication and change management skills are integral to the success of the role. Conclusion: The TSCs are highly recognised within the transfusion team and the role continues to evolve with the changes in the Australian blood sector. The term Transfusion Safety Coordinators (TSCs) has been used to describe roles such as transfusion nurse/trainer/practitioner/safety officer/clinical nurse consultant and PBM nurses.

Background Transfusion and patient blood management (PBM) processes are complex; while transfusions can be life‐saving, equally there may be associated morbidity and mortality. In Australia, obligations to comply with mandatory governance frameworks have propelled the safety and PBM culture. These frameworks support appropriate product use and levels of safety at all points of the process. Methods A key to blood management governance success is the multidisciplinary Blood Management team/Governance Committee. This team includes healthcare executive, clinical governance, consumer/s and medical/laboratory/nursing representatives, with the transfusion practitioner (TP) as a key resource. The TP is often seen as the driving force for change, working in a multidisciplinary capacity across the clinical spectrum. In Australia, this influence can be within an individual organization, across multiple sites/networks, in metropolitan or rural/regional areas. The TP conducts a critical role pulling together resources, promoting exchange of information, encouraging engagement and empowering colleagues to facilitate change. Highly developed communication skills assist the TP to engage these many different stakeholders and clinical environments. Collaboration is essential for the multidisciplinary team to function effectively. Highly functional teams recognize knowledge and experience and utilize each member's skills to work together to deliver the best possible outcome for patients. There is a growing body of literature supporting multidisciplinary teams and the TP role improving patient outcomes. Conclusion Effective transfusion and PBM practice require a systematic cross‐specialty approach to ensure success. TPs are an essential link in the multidisciplinary chain and require strong support and leadership to potently effect change and enhance practice.

The transfusion process is complex, involving many interlinking chains of events, and a multidisciplinary group of health professionals with different levels of awareness and understanding of transfusion practice. In recent years, many measures have been implemented to increase blood component safety and the clinical transfusion process. Haemovigilance programs report the greatest risks to patients from transfusion in many countries now relate to hospital-based steps in the process.The role of the Transfusion Nurse (TN) is evolving as an integral part of efforts to optimise appropriate use of blood components, reduce procedural risks and improve transfusion practice generally. The TN position is a relatively recent specialist role within hospitals and blood services, and continues to develop with growing experience of areas requiring intervention in the clinical setting, and increasing expectations for improvements in transfusion clinical governance.The role typically includes activities to improve clinician and patient awareness of transfusion issues and practical knowledge of blood product use, and therefore to improve clinical decision-making and enhance blood administration processes, along with responsibilities for education/training, auditing and adverse event follow-up. Within the Blood Service in Australia the role also covers approval and provision of specialised blood products along with many of the hospital-based TN functions.The TN serves as an expert resource and has been fundamental in development of tools, resources and skills in the following areas:-Patient blood management:Benchmarking across organizations has demonstrated that availability and review of comparative data can be a powerful motivator of change. Reviews of the TN role/programmes highlighted their effectiveness and resulted in ongoing support/funding. Skills and attributes such as confidence, persistence, energy, excellent communication/ technical knowledge and clinical experience are key requirements for the roles success. ConclusionThe specialist transfusion practitioner/Transfusion Nurse is an integral part of a multidisciplinary team, supporting efforts at institutional and national levels to reduce transfusion risks and improve practice.