None listed
Conditions
Brief summary
Blood collected from volunteers, also known as allogeneic blood, is donated, processed and made available for patients requiring transfusion, such as during surgery. This is an expensive process; according to the National Blood Authority, the estimated cost associated with blood transfusion in Australia is over $1 billion per year. While the safety of allogeneic blood transfusions has improved over decades, life-threatening risks remain. For example, 617 transfusion-related adverse events were reported in Australia in 2013-2014. These adverse events include wrong blood to wrong patient, transfusion-related lung injury, allergic reaction, infection, cancer recurrence, organ failure and death. Research has linked some of these outcomes to a post-transfusion impairment of the patient’s immune responses. In order to better understand how this happens, the Australian Red Cross Blood Service has developed a series of tests to characterise how transfusion impairs these immune responses. Intraoperative cell salvage is a process where blood lost during surgery is collected, processed and given back to the patient. Use of intraoperative cell salvage may provide a cost-effective and safer alternative to allogeneic blood transfusion. In particular, because patients aren’t exposed to blood from another person, it seems likely that the impairment of immune responses that occurs following allogeneic blood transfusion will be prevented. However, whether or not this assumption is true remains to be investigated. Therefore this research project aims to investigate whether the process of intraoperative cell salvage affects the immune responses of patients. To do so, this research project will use the existing series of assays already developed by the Australian Red Cross Blood Service. This project will be highly significant to the health care system as we anticipate that intraoperative cell salvage, as an alternative to allogeneic blood transfusion, results in better patient care, less harm to patients and a decrease in costs. This important research is led by Dr Michelle Roets, a senior anaesthetist at the Royal Brisbane and Women’s Hospital who has been researching improvements in blood management over the past 10 years. Her work has resulted in authorship of the ‘Guidance for the Provision of Intraoperative Cell Salvage’ National documents with the National Blood Authority in Australia. Dr Roets has teamed up with the Australian Red Cross Service to co-ordinate an expert team and evaluate the association between immune suppression and infection risk after allogeneic blood transfusion compared to intraoperative cell salvage. These results hope to significantly improve current blood administration practice.
Interventions
Blood samples will be collected from 20 participants by clinicians (trained and experienced in phlebotomy) at the Royal Brisbane and Women’s Hospital and analysed at the Red Cross Blood service through a panel of tests/assays to evaluate the immune response related to blood transfusion and cell salvage.
This is the first time a prospective analysis of the cell salvage product and patient immune response has been carried out. The study protocol, logistics etc. are all required to be established.
Blood samples will be collected from 20 participants by clinicians (trained and experienced in phlebotomy) at the Royal Brisbane and Women’s Hospital and analysed at the Red Cross Blood service through a panel of tests/assays to evaluate the immune response related to blood transfusion and cell salvage. This is the first time a prospective analysis of the cell salvage product and patient immune response has been carried out. The study protocol, logistics etc. are all required to be established. This study will recruit 20 patients as a pilot. In view of the fact that the study is novel, there is no published data available where the full panel of assays proposed were used to test and compare allogeneic blood transfusion and intraoperative cell salvage responses. Therefore there is no comparable (published) data to base an accurate power analysis and sample size on. Intended samples: 1) Before surgery (patient sample), (Sample 1) 2) After cell salvage processing (product sample), (Sample 2) 3) After cell salvage filtering (product sample), (Sample 3) 4) Immediately after surgery (patient sample), and (Sample 4) 5) At day 3 after surgery (patient sample). (Sample 5) “TRIM is a complex inflammatory process” and the lack of diagnostic criteria make it difficult to define. It is best to consider the proposed project as a project of three parts. The first part of the study: Samples 2 and 3 will be used to characterise the cell salvage product at different stages of its production by using established panels at the blood service. The second part of the study: Samples 1, 4 and 5 will be used to assess ABT and ICS immune response using established assays at the blood service. Specifically the immune response will be assessed in an in vitro assay. In addition to direct assessment of the patient responses, we had added a transfusion assay where we will mix the admission sample with allogeneic (routine collected and stored blood at the blood service) to see whether there is a difference in immune profile following exposure to cell salvaged vs. allogeneic blood. Samples 1 and 4 will be taken by the anaesthetic team (anaesthetic consultant or registrar) looking after the patient from the arterial line (if available) or else through standard phlebotomy technique straight from a vein. Samples 2 and 3 will be taken by the autotransfusionist from the intraoperative cell salvage circuit. Sample 5 will be taken through standard phlebotomy by an anaesthetist or research nurse in the ward on day 3. The third part of the study will investigate whether cell salvage can reduce immune modulation associated with transfusion. For this assessment, an in vitro transfusion model previously established at the Blood Service, will be used. Briefly, pre-surgery patient blood (sample 1) will be cultured with cell salvage product (sample 3) or ABO compatible allogenic blood (provided by the Blood Service). In parallel, responses to bacterial infection will be modelled using lipopolysaccharide (LPS). Following six hours of exposure, dendritic cell and monocyte specific immune responses will be assessed.
Sponsors
Michelle Roets
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
20 patients undergoing orthopaedic procedures, who are scheduled to receive intraoperative cell salvage as per our standard practise and process, will be included. Inclusion Criteria (as per our standard operating procedure): 1. Patients aged> 18 years. 2. Scheduled for elective Orthopedic procedures with an expected blood loss of more than 1000ml (as per our standard protocol).
Exclusion criteria
Exclusion criteria: 1. Pregnant patients. 2. Patient refusal or inability to provide consent.
Outcome results
None listed