None listed
Conditions
Brief summary
Infants and children requiring surgery often experience significant blood loss. Blood consists of several components that are required to maintain normal physiological processes. Included within our blood are red blood cells, white blood cells, platelets and proteins. One of the main roles of blood is to maintain haemostasis, a balance to ensure blood clots appropriately when tissue trauma occurs. When large volumes of blood loss occur, components of blood responsible for forming a clot are lost and require replacement to ensure cessation of blood loss and tissue healing. During surgery for craniosynostosis, due to the nature of the surgery, a large volume of blood is lost. Anaesthetists are very experienced in observing the blood loss and replacing blood products to ensure appropriate amount of red blood cells are present and that blood haemostasis is maintained, keeping the child safe. At the Queensland Children’s Hospital, we found that up to 33% of patients received blood products to assist with maintaining haemostasis. Typically, anaesthetists will use blood tests that are sent to the laboratory to determine appropriate clotting function. Typically, a child’s blood loss occurs quicker than the return of accurate results, therefore blood products used to assist clotting, including fresh frozen plasma, cryoprecipitate, platelets will be replaced based on perceived total volume of blood lost. Recently point of care viscoelastic haemostatic assay utilising a ‘thromboelastogram, (TEG)’ has been incorporated into clinical practice to guide transfusion of blood products responsible for haemostasis. In an audit of our clinical practice for craniosynostosis 43% of cases utilised TEG to guide haemostatic therapy. As such we have varied clinical practice of clinicians within our department. The evidence regarding the benefit of viscoelastic haemostatic assays in the elective paediatric surgical population is limited. To date there have been no high-quality studies comparing an anaesthetic physician guided, utilising standard coagulation tests, to a viscoelastic haemostatic assay guided transfusion strategy. We aim to compare the two techniques using a randomised controlled trial in infants having surgery for craniosynostosis. Initially our study at Queensland Children’s Hospital will be a feasibility study. If it can be conducted well, we plan to incorporate other paediatric hospitals within Australia to increase patient recruitment.
Interventions
Non-red blood cell products will be transfused in line with protocol as displayed in ‘TEG6 guided massive transfusion strategy’. Should these results be unavailable despite a clinical need for blood volume replacement or haemodynamic instability, non-red cell products will be transfused at the anaesthetists’ discretion based on perceived haemostatic need and on recommendation of Queensland Children's Hospital Massive Transfusion Protocol.
As per standard institutional practice during craniosyn
Non-red blood cell products will be transfused in line with protocol as displayed in ‘TEG6 guided massive transfusion strategy’. Should these results be unavailable despite a clinical need for blood volume replacement or haemodynamic instability, non-red cell products will be transfused at the anaesthetists’ discretion based on perceived haemostatic need and on recommendation of Queensland Children's Hospital Massive Transfusion Protocol. As per standard institutional practice during craniosynostosis surgery bloods (including arterial blood gas, full blood count, Standard Coagulation profile) are performed on initiation of surgery, hourly, and cessation of surgery. Also it is performed if blood loss or clinician need requires and after non-red cell products have been administered. Typically surgery lasts for a duration of three hours, pending surgical difficulty or surgical complication. Each sampling represents a total volume of 2.1mls each time and sampling typically occurs 3-5 times preoperatively. The use of viscoelastic haemostatic assay via the TEG6s device (Haemonetics) will add an additional 1.3 mls each sample. Of which will be discussed as part of patient consent. This corresponds to the guidelines for the blood sampling in children for clinical research recommend a maximum of 3ml/kg over a 24-hour period or 10% of total blood volume over a period of 8 weeks.(1) The protocol of non-red cell transfusion will be in line with our departmental Thromboelastography guideline, specifically 'HUMPTY DUMPTY TEG6s guided massive transfusion strategy'. This has been adapted from recommendations from Haemonetics Thromboelastography guidelines.(2) Specifically providing recommendations based on the parameters of the viscoelastic assay to replace specific products. For example if evidence of fibrinogen, platelet, factor deficiency will be replaced with cryoprecipitate, pooled platelets and fresh frozen plasma. Volume of non-red cell product given will be based on recommendations from our departmental thromboelastography guideline. We will have a dedicated anaesthetic research nurse whom will be performing preoperative consent, performing the appropriate blood sampling and data collection. She is trained in quality assured thromboelastography sampling. The results of the sampling will be displayed in real time via computer display, and if not within normal range the anaesthetic clinician will transfuse according to protocol. It will be research nurse role to ensure the results are displayed and that the clinician has access to a visual protocol to guide protocol replacement. The research nurse will not provide recommendations nor interpretation of results. She will record data in real time, as per ‘case report form’ regarding feasibility and timing, amount and type of products and fluids transfused. Our trial is a feasibility trial primarily observing recruitment, and adherence to the intervention protocol. It will record transfusion requirements and deviation, including reasons, from protocol. The intention being to determine suitability for multi-site national trial. TEG guided massive transfusion strategy was a protocol devised departmentally as a guideline within the Anaesthetic department of the Queensland Children’s Hospital. It utilises normal ranges given by Haemonetics responsible for the design of this specific viscoelastic haemostatic assay type.(3) Our protocol also utilises the Queensland Children’s Hospital Massive Transfusion Protocol. Currently we are looking to getting the current protocol approved through the QCH Blood Management Committee to be included in our hospital Massive transfusion protocol.(4) The Haemonetics TEG6s Hemostasis Analyzer, will be utilised for the viscoelastic haemostatic assay.(3) We have a pool of 5 anaesthetic specialists whom are responsible for performing the anaesthesia for craniosynostosis surgery. The participants have previously undertaken and have received certification for analysis and interpretation of Haemonetics TEG6s Hemostasis Analyser via the web based Haemonetics TEG6s e-learning modules. This will be repeated prior to the co-design phase. The specialists have also previously received departmental education regarding the departmental TEG guided massive transfusion strategy . As such will be familiar with it’s use. Participants will be involved in 3, 1 hour focus groups during the study. The first being prior to commencement of recruitment, halfway through the recruitment period and after completion of recruitment). Identifying and clarify any enablers and barriers to implementation. As part of this process we will utilise a ‘Theoretical Framework of Acceptability Tool’ (5) and ‘Feasibility of Intervention Measure Tool’.(6) During the codesign process, participants will be given the protocol and asked to provide feedback and suggestions with implementation. (1)Royal College of Paediatrics and Child Health. Evidence statement. Major trauma and the use of tranexamic acid in children. November 2012. (2)Haemonetics TEG6 e-learning: tegtraining.haemonetics.com (3) Haemonetics TEG 6s Hemostasis Analyzer: https://teg.haemonetics.com (4) Children’s Health Queensland Hospital and Health Service. Blood and Blood Products: Massive Haemorrhage Protocol (MHP) version 3.0 (5) Sekohn et. Al. ‘Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework”. BMC Health Services Research (2017) 17:88 (6) Weiner BJ, Lewis CC, Stanick C, et al. “Psychometric assessment of three newly developed implementation outcome measures”. Implementation Sci (2017) 12:108
Sponsors
Queensland Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Healthy volunteers
No
Inclusion criteria
Elective total cranial vault and / or bifrontal orbital advancement surgery for craniosynostosis with anticipated massive blood loss (> 40mls/kg)
Exclusion criteria
Congenital or acquired bleeding disorder (known or suspected); Perioperative anti-platelet and / or anticoagulant use Previous cranial vault surgery Refusal for consent Intercurrent illness rendering surgery or anaesthesia unsafe
Outcome results
None listed