Major Haemorrhage Protocol Research Articles

Ward-based in situ simulation: lessons learnt from a UK District General Hospital

IntroductionIn situ simulation (ISS) enables multiprofessional healthcare teams to train for real emergencies in their own working environment and identify latent patient safety threats. This study aimed to determine ISS...

Patient blood management guideline for adults with critical bleeding.

The management of patients with critical bleeding requires a multidisciplinary approach to achieve haemostasis, optimise physiology, and guide blood component use. The 2011 Patient blood management guidelines: module 1 - critical bleeding/massive transfusion were updated and published. Systematic reviews were conducted for pre-specified research questions, and recommendations were based on meta-analyses of included studies. The critical bleeding/massive transfusion guideline includes seven recommendations and 11 good practice statements addressing: major haemorrhage protocols (MHPs) facilitating a multidisciplinary approach to haemorrhage control, correction of coagulopathy and normalisation of physiological derangement; measurement of physiological, biochemical and metabolic parameters in critical bleeding/massive transfusion; the optimal ratio of red blood cells to other blood components; the use of tranexamic acid; viscoelastic haemostatic assays; and cell salvage. The new guideline recommends MHPs be established as standard of care in all institutions managing patients with critical bleeding. In addition to routine physiological markers, the new guideline recommends temperature, biochemistry and coagulation profiles be measured early and frequently, providing parameters that define critical derangements. Ratio-based MHPs should include no fewer than four units of fresh frozen plasma and one adult unit of platelets for every eight units of red blood cells. In the setting of trauma and obstetric haemorrhage, administration of tranexamic acid within three hours of bleeding onset is recommended. The use of recombinant activated factor VII (rFVIIa) is not recommended. There was insufficient evidence to make recommendations on the use of viscoelastic haemostatic assays or cell salvage as part of MHPs.

Contemporary management of major haemorrhage in critical care.

Haemorrhagic shock is frequent in critical care settings and responsible for a high mortality rate due to multiple organ dysfunction and coagulopathy. The management of critically ill patients with bleeding and shock is complex, and treatment of these patients must be rapid and definitive. The administration of large volumes of blood components leads to major physiological alterations which must be mitigated during and after bleeding. Early recognition of bleeding and coagulopathy, understanding the underlying pathophysiology related to specific disease states, and the development of individualised management protocols are important for optimal outcomes. This review describes the contemporary understanding of the pathophysiology of various types of coagulopathic bleeding; the diagnosis and management of critically ill bleeding patients, including major haemorrhage protocols and post-transfusion management; and finally highlights recent areas of opportunity to better understand optimal management strategies for managing bleeding in the intensive care unit (ICU).

A91Integrating Simulation Based Education to Trauma & Orthopaedic Training: A Regional Experience

In recent years we have seen an exponential increase in the use of simulation-based education (SBE) within surgical training. Early evidence supported initial integration of simulation to Trauma & Orthopaedic (T&O) training [1] with more contemporary evidence focused on refining training methods and technology usage [2,3]. We aim to assess the integration of established as well as novel SBE components within our T&O training programme in Northern Ireland. Simulation sessions were introduced to the Northern Ireland (NI) T&O Core Curriculum in academic year 2022/23: Trauma Simulation Scenario Training: Pelvic trauma scenarios were delivered to all T&O specialist trainees as part of Core Curriculum teaching in a regional simulation centre. Multi-professional input was sought and delivered by Blood Transfusion Service (Major Haemorrhage Protocol training) and Urological micro-teaching session (traumatic urological injuries in setting of pelvic trauma). Arthroscopy Simulation Course: A knee arthroscopy course was developed in conjunction with industry for all T&O trainees in NI utilizing passive haptic feedback arthroscopy simulators. Pre + post simulation surveys were completed assessing educational value, engagement with SBE as method of teaching, desire for further SBE content and suggestions for topics of same. Focus groups of lead educators were set up to plan development of further SBE training within T&O curriculum. Trainees reported increased confidence in management of pelvic trauma. Overwhelmingly positive response to integration of SBE sessions to core curriculum with 89% in favour of further multi-specialty simulation training sessions. There was a preference seen within feedback for a variety of SBE iterations with in-situ and operative/ procedural simulation being slightly preferred to scenario-based training. With majority of trainees requesting procedural SBE training as topic for future sessions, Knee Arthroscopy Simulation Course was subsequently developed (to be delivered as part of Core Curriculum in May 2023). From lead educator focus groups further simulation-based training sessions are planned for development in 2023/24 including shoulder arthroscopy simulation course, rare approaches simulation and advanced supracondylar simulation sessions. Feedback will be sought throughout to ensure training is tailored to needs of trainees as well as curriculum requirements. Recognition of benefits and scope of SBE training within T&O has prompted development of formal simulation trainee role as result of initial regional experience. Our experience of integrating SBE training methods to T&O core curriculum has been hugely positive with demand amongst trainees high for a wide range of further sessions and courses. Authors confirm that all relevant ethical standards for research conduct and dissemination have been met. The submitting author confirms that relevant ethical approval was granted, if applicable.

FTP1.7 Critical decision analysis of pre-hospital major haemorrhage protocol activation

Abstract Aims Major haemorrhage protocol activation (MHPA) facilitates immediate blood product availability and institutional capacity readiness for bleeding trauma patients. MHPA is a difficult decision pre-hospital, where two thirds of MHPAs occur. We aimed to identify the determinants and influences of the pre-hospital MHPA decision. Methods This prospective qualitative study had Health Research Authority approval (REC 22/PR/0089). Physicians from one helicopter emergency medical service (HEMS) were purposively sampled. Written informed consent was obtained. Cases representing difficult MHPA decisions within the previous six months were included. Semi-structured interviews were conducted via Microsoft Teams, following the critical decision analysis method. Interviews were transcribed and analysed using a 6-step inductive thematic analysis method on NVivo. Results Twelve interviews were conducted with nine participants: median age 37 years (range 34-45), median post-graduate experience 12 years (IQR 10.5-14.8), and median HEMS experience 1 year (IQR 0.5-4.9). Cues for (and against) the MHPA decision included: hard evidence of bleeding (or bleeding judged to be non-severe); initial information fit their mental model of a bleeding patient (or did not); patient deterioration (or response to resuscitation); acknowledgement that injuries and bleeding can be missed (or uncertainty of clinical findings); and alternative diagnoses were considered less likely (or more likely). Other influences of the MHPA decision were heuristics (especially anchoring bias), situational awareness, previous experience, colleagues on-scene, time- and task-pressure, and the desire for diagnostic accuracy and professional reputation. Conclusions Multiple determinants and influences affect the pre-hospital MHPA decision. Acknowledging these cognitive processes will inform efforts to improve decision-making in trauma.

Testing the robustness of emergency department process pathways using multidisciplinary team in-situ simulation

Delivering safe and best practice is dependent on robust structural processes and optimal acquisition of skills and knowledge across disciplines [1]. An in-situ simulation-based education model was implemented to optimise the provision of best practice in emergency medicine [2]. In-situ simulation cases were developed based on critical incidents, complaints, and interesting cases. These simulations were designed to be complex cases, aimed at high-level multi-specialty working. Maintaining the real-life integrity of the simulation cases was paramount. The simulations were run in a busy Emergency Department (ED), during the working day while the normal service continued. Participants were instructed to make-up medication, collect blood products, and contact specialities in real time. Debriefing initially included identifying communication, human factor and process issues, and concluded with medical teaching on the topic covered, and included the speciality perspective on optimal medical management. Logistical support was provided by the simulation faculty. Data from feedback forms was collected. Over 12 months, 20 simulations cases were conducted in the resuscitation area of the ED. Simulations involved multidisciplinary, multi-speciality workforce covering the management of acute bronchitis in an infant, an episode of acute psychosis, upper gastrointestinal bleed requiring major haemorrhage protocol activation, and many other emergencies covering the full spectrum of specialities. All feedback strongly agreed/agreed that the simulation exercises were beneficial and would lead to an improvement in the participants’ clinical practice. The multidisciplinary approach was key to the discovery of system weaknesses and risk-factors. These were then addressed and improvements in system learning, and processes were proven by the re-running of similar scenarios. The learning points were communicated via the hospital ED guideline application (AskEarl) and departmental communication channels. Changes have included updating standard operating procedures, guidelines, and the application of a business case for a blood fridge located in ED to reduce blood administration length of time. These detailed simulations successfully tested the current hospital processes and resulted in significant improvements to the daily structural delivery of best practise. Additionally, the SBE model decreased clinician teaching preparation burden and increased simulation efficiency and effectiveness. After the success of this model, it is being rolled out to other specialities. We would like to acknowledge and thank the Dinwoodie Charitable Company for their support. 1. Gressgård LJ. Knowledge management and safety compliance in a high-risk distributed organizational system. Safety and health at work. 2014;5(2):53–59. 2. Petrosoniak A, Auerbach M, Wong AH, Hicks CM. In situ simulation in emergency medicine: moving beyond the simulation lab. Emergency Medicine Australasia. 2017;29(1):83–88.

591 Abdominal Apoplexy – a Case of Spontaneous Haemoperitoneum from Pancreaticoduodenal Artery Bleed

Abstract Background Inferior pancreaticoduodenal artery (IPDA) haemorrhages are extremely rare and often occur secondary to IPDA aneurysms. They can result in a spontaneous life-threatening bleed which requires urgent treatment via transcatheter arterial embolisation (TAE). Case Summary We report the case of an IPDA haemorrhage in a 52-year-old male who presented with a one-day history of severe worsening generalised abdominal pain. Although his initial blood pressure, heart rate and haemoglobin were within the normal range, he had a persistent metabolic acidosis with raised lactate. This prompted an urgent out-of-hours Computed Tomography (CT) scan. On return to the ward, he had a syncopal episode and was found to be in shock. An urgent venous blood gas revealed a substantial haemoglobin drop (133g/L to 88g/L) and review of his imaging identified intra-abdominal haemorrhage, confirmed by radiology to be an IPDA haemorrhage. The patient was managed according to the trust's major haemorrhage protocol and blue light transfer to a tertiary centre for embolisation by interventional radiology was arranged. He was transferred with ongoing resuscitation, and successfully underwent TAE of the IPDA. No aneurysm or other pathology was noted on angiography. Conclusion IPDA haemorrhages are uncommon. Physiological compensation may normalise initial observations and initial haemoglobin level may also be falsely reassuring. Therefore, it is important to monitor physiological indicators, such as pH and lactate, as real-time severity indicators to identify emergency pathology early.

P08 Routine group and save for elective laparoscopic cholecystectomy

Abstract Introduction Laparoscopic cholecystectomy is the gold standard management for symptomatic cholelithiasis. Intraoperative vascular injury necessitating blood transfusion is a serious but rare complication, typically occurring during dissection around Calot's triangle or trocar insertion. Despite this, standard practice continues to incorporate the obtainment of historic and repeat group and save (G&S) samples to facilitate potential intraoperative transfusion of cross-matched blood. These are relatively expensive (£6.93/sample), time-consuming, and potentially distressing to patients. We review the requirement to obtain routine preoperative G&S samples whilst maintaining patient safety. Methods We performed a retrospective analysis of all patients having undergone elective laparoscopic cholecystectomy in a single centre during a six-month period in 2021. Seventy-nine patients were identified (53 female; 26 male), with a mean age of 52 years (range 22–80). Results All patients underwent historic G&S and 73% underwent same-day confirmatory samples. No patients required intraoperative or postoperative blood transfusion. Intraoperative bleeding occurred in two cases but neither required transfusion. Nineteen patients (24%) were admitted postoperatively for reasons including conversion to an open procedure (6%), uncontrolled pain, damage to surrounding structures, and the presence of multiple comorbidities. Conclusion As such, we propose that routine preoperative G&S samples are not required to undertake safe elective laparoscopic cholecystectomy. In the event of major vascular injury necessitating emergency intraoperative blood transfusion, the major haemorrhage protocol may be activated, and universal donor blood administered. However, routine G&S is recommended in the presence of significant comorbidities (e.g., bleeding diathesis), high likelihood of conversion to an open procedure, or preoperative anaemia. Take-home message Group and save samples are routinely obtained prior to elective laparoscopic cholecystectomy despite there very rarely being a need for intraoperative or postoperative blood transfusion. Based on our single centre, retrospective cohort study, we propose that such samples need not be obtained aside from in higher risk cases.

P.118 Survey evaluation of major obstetric haemorrhage protocols across the UK

P.118 Survey evaluation of major obstetric haemorrhage protocols across the UK

Rotational thromboelastometry in children presenting to an Australian major trauma centre: A retrospective cohort study.

ObjectiveThis retrospective cohort study aims to describe patterns of rotational thromboelastometry (ROTEM™) results in paediatric trauma following the implementation of a ROTEM‐guided critical bleeding algorithm and major haemorrhage protocol (MHP).MethodsThis retrospective observational study was conducted in a tertiary trauma hospital in Queensland, Australia, where point‐of‐care ROTEM was introduced for paediatric patients in 2014. All children aged less than 18 years who had a ROTEM test during their presentation between January 2014 and December 2017 for a traumatic injury were included in the dataset. Other children with a record in the hospital's trauma registry in the same period were also screened for blood product usage. Data were collected for frequency of ROTEM testing, pathology and ROTEM results, blood product and antifibrinolytic use along with injury related data. Compliance with recommended treatment thresholds for detected coagulopathy was also reviewed.ResultsA total of 1039 children were listed in the trauma registry, including 167 children having a ROTEM test for trauma. Factors significantly associated with having a ROTEM test were older age, higher injury severity score (ISS >12) and penetrating injury. A result exceeding a treatment threshold was returned for 122 (73.1%) of 167 children, with hyperfibrinolysis identified in 88 (52.6%) of 167 and hypofibrinogenaemia identified in 54 (32.3%) of 167. Adherence with the recommended treatments for those children where a treatment threshold was exceeded was low in this cohort.ConclusionThe use of ROTEM‐guided blood component replacement is an emerging practice in children for both traumatic and non‐traumatic bleeding. Targeted replacement of identified coagulation defects guided by rapid point‐of‐care testing is an emerging alternative to fixed‐ratio‐based protocols. Further research is required to validate treatment thresholds in the paediatric population and further investigate the clinical outcomes for patients as a result of early correction of trauma‐induced coagulopathy.

194 Implementing a Simulation Training Programme for Physician Associates

The physician associate (PAs) profession is a relatively new profession to the NHS. As such, there is no official national or regionally agreed further training to support PAs transitioning from PA school into clinical practice once they have graduated. Simulation training has proved to be an effective tool for developing clinical and non-clinical skills in other groups of clinicians We aimed to describe the development and implementation of a novel PA-specific simulation training programme and present the evaluation of our initial work.We designed and implemented a bespoke simulation training programme based on existing training for junior doctors. This model has three separate simulation sessions, spaced over 2 years, each session has three different clinical scenarios. Seventeen PAs have undergone the first two sessions. The first session contained three scenarios that highlighted important local protocols such as the major haemorrhage protocol and the sepsis At this point in time, we have feedback from 16 candidates from session 1 and 11 from session 2. The results are overwhelmingly positive showing improved confidence, better team-working skills and a perceived perception of improved patient safety following the simulation training, as shown in graphs 1 and 2. The majority of candidates partaking in the session found the simulation training beneficial to their practise. The main negative feedback given was the lack of ‘senior support’ (i.e. from a senior doctor) in the scenarios that were unrealistic to actual practice.The introduction of a novel PA simulation training programme has demonstrated improvements in clinical and non-clinical skills. This supports our aim of improving post-graduate PA training. Work continues to further develop our PA simulation programme and further evaluate its effectiveness with the aim of making this as a regional simulation programme that PAs can undertake when joining the healthcare workforce.

SP9.1.7 Emergency Laparotomy for Trauma in the United Kingdom and Ireland: a Prospective Multicentre Study

Abstract Aims Trauma patients requiring abdominal surgery have significant morbidity and mortality, but are not included in existing national audits of emergency laparotomy. The aim of this study was to examine processes of care and outcomes among trauma patients undergoing emergency abdominal surgery in the UK and Ireland. Methods A prospective trainee-led multicentre audit was conducted over six months from January 2019 across the national trauma system. Patients undergoing laparotomy or laparoscopy within 24 hours of injury were included. Subgroup analysis was conducted in those requiring major haemorrhage protocol (MHP) activation. Results The study included 363 patients from 34 hospitals (22 major trauma centres). The majority were young males with no co-morbidities who required surgery for control of bleeding (51%) or exploration of penetrating injuries (46%). Over 85% received consultant-led care in the emergency department (318/363) and operating theatre (321/363). The MHP subgroup made up 45% of the cohort but accounted for 97% of deaths and 79% of ICU days, with a mortality rate of 19% and a massive transfusion rate of 32%. Compared to non-MHP patients they had shorter times to theatre (122 vs 218 minutes, p < 0.001), higher rates of advanced prehospital care (60% vs 33%, p < 0.001) and higher rates of consultant-led care (95% vs 85%, p < 0.001). Conclusion The majority of trauma patients requiring emergency abdominal surgery receive consultant-delivered perioperative care which is appropriately tailored to patient risk profile. Despite this, mortality and resource utilization among high-risk patients remains substantial, justifying ongoing performance improvement initiatives and research into novel therapeutics.

1002 Calcium administration in Major haemorrhage Protocol

Abstract Introduction Calcium gluconate is an essential part of the major haemorrhage protocol (MHP). It minimizes the exacerbation of transfusion coagulopathies due to the citrate preservative. As fifty percent of trauma patients present with hypocalcaemia prior to transfusion, the risk is pertinent. Given the importance of the issue, surprisingly current guidelines remain sparse. We analysed the percentage of patients who received calcium and their hypocalcaemia incidence. Method A Retrospective review of red traumas during June to August 2019. The frequency of MHP and the patient’s ionised plasma calcium levels on VBG (1.15-1.26mmol/L) were identified. Our standard stated 100% of MHP should receive calcium. A massive transfusion was defined as 10 red blood cells units in 24 hours or 4 blood products within 30mins. Results 27 red traumas were accepted to audit, MHP was activated in 85%. Out of these 75% received calcium and on average after 6.4 units of blood products. The incidence of ionised hypocalcaemia in all MHP patients was 67%. Conclusions We identified a standard that supplementary calcium should be supplemented in all MHPs. Hypocalcaemia was more frequency than our research stipulated. Improvement needs to be made to meet standards. We recommend incorporation of Calcium gluconate into major haemorrhage pack and transfusion guidelines.

Changes in emergency department blood product use for major paediatric trauma following the implementation of a major haemorrhage protocol.

Fixed ratio blood product administration may improve outcomes in trauma patients with massive blood loss. The present study aimed to describe the impact of a major haemorrhage protocol (MHP) on the ratio of blood products administered for paediatric major trauma. Retrospective observational study in a state-designated paediatric major trauma centre in Melbourne, Australia. Children with major trauma who received blood products in the ED were identified from a hospital trauma registry. Blood product ratios before, during and after implementation of a hospital MHP were compared in consecutive 2 year blocks. Over a 6 year period, 767 major trauma patients were identified, of whom 47 received blood products in the ED and were included in the analysis; 14 pre-MHP implementation, 24 during-MHP implementation and nine post-MHP implementation. No patients received blood products at a ratio of 1:1:1 for red blood cells:fresh frozen plasma:platelets, respectively, during any time period. In this cohort of predominantly blunt trauma, blood products were infrequently administered in the ED because of the low prevalence of massive blood loss. Coagulopathy and hypofibrinogenaemia were commonly observed, nearly half of included patients were managed operatively and one quarter did not survive their injuries. The implementation of a MHP did not change the ratio of blood product administration in this cohort of patients because of the infrequency of massive blood loss. Future studies may focus on the impact of treating coagulopathy and hypofibrinogenaemia on patient-centred outcomes.

The use of ‘viscoelastic tests’ in driving transfusion needs in major trauma patients

Haemorrhage can be attributed to approximately 50% of the 5 million trauma deaths worldwide every year. The development of damage control resuscitation techniques and major haemorrhage protocols has revolutionized trauma resuscitation. In this review we aim to explore the phenomenon of acute traumatic coagulopathy, the history and development of ‘viscoelastic tests’, the theory behind their use, the basic nomenclature and the role of these tests within the clotting cascade. We also look at the assessment of acute traumatic coagulopathy and the role of viscoelastic tests within goal-directed trauma resuscitation. Of particular interest is a review of the current recommendations for the implementation of thromboelastic tests in major haemorrhage guidelines and protocols.

Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial

PurposeContemporary trauma resuscitation prioritizes control of bleeding and uses major haemorrhage protocols (MHPs) to prevent and treat coagulopathy. We aimed to determine whether augmenting MHPs with Viscoelastic Haemostatic Assays (VHA) would improve outcomes compared to Conventional Coagulation Tests (CCTs).MethodsThis was a multi-centre, randomized controlled trial comparing outcomes in trauma patients who received empiric MHPs, augmented by either VHA or CCT-guided interventions. Primary outcome was the proportion of subjects who, at 24 h after injury, were alive and free of massive transfusion (10 or more red cell transfusions). Secondary outcomes included 28-day mortality. Pre-specified subgroups included patients with severe traumatic brain injury (TBI).ResultsOf 396 patients in the intention to treat analysis, 201 were allocated to VHA and 195 to CCT-guided therapy. At 24 h, there was no difference in the proportion of patients who were alive and free of massive transfusion (VHA: 67%, CCT: 64%, OR 1.15, 95% CI 0.76–1.73). 28-day mortality was not different overall (VHA: 25%, CCT: 28%, OR 0.84, 95% CI 0.54–1.31), nor were there differences in other secondary outcomes or serious adverse events. In pre-specified subgroups, there were no differences in primary outcomes. In the pre-specified subgroup of 74 patients with TBI, 64% were alive and free of massive transfusion at 24 h compared to 46% in the CCT arm (OR 2.12, 95% CI 0.84–5.34).ConclusionThere was no difference in overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols.

Implementation of point-of-care ROTEM® into a trauma major haemorrhage protocol: A before and after study.

The aim of the present study was to assess transfusion practices with the implementation of a targeted viscoelastic haemostatic assay (VHA) (ROTEM®) guided coagulation management programme into a major haemorrhage protocol for trauma patients requiring ICU admission, starting from time of arrival in the ED. This retrospective observational study was conducted in a major trauma centre in Australia. One hundred and sixty-two trauma patients admitted to the ICU between January 2013 and December 2015 with an Injury Severity Score ≥12 and who received blood products were included: 37 in the pre-group, 48 during implementation and 77 in post-group. The primary outcome was blood and blood product administration amounts. Packed red blood cell transfusion amounts did not significantly change post introduction of the ROTEM®. There was a significant increase in fibrinogen replacement between the pre- and post-groups (P < 0.001), accompanied by a reduction in the use of fresh frozen plasma (P < 0.001) and prothrombinex (P < 0.001). Platelet usage in the post-group was higher but not reaching statistical significance (P = 0.051). Post-implementation point-of-care ROTEM® testing was able to be performed in the ED in 94.8% of cases. Although there was no overall reduction of packed red blood cell usage, a change in the pattern of administration of other blood products was observed with the implementation of a targeted VHA (ROTEM®) guided coagulation management programme. Larger studies are needed to further define the role of early VHA testing to guide correction of trauma-induced coagulopathy and the effect on clinical outcomes.

Implementation and evaluation of a major haemorrhage protocol in the Emergency Department Resuscitation Area in the University-affiliated Hospital of Brest (France).

A single-centre study was conducted to compare two periods, before and after institution of a massive haemorrhage protocol including the use of massive transfusion orders and the availability of packed red blood cell concentrates prior to patient's admission. Two groups of patients (in both trauma and non-trauma settings) were defined: "before protocol" and "after protocol". The primary outcome was the median transfusion time for a unit of red blood cell concentrate. Forty patients were included: 22 for the "pre-protocol" group and 18 for the "post-protocol" group. The two groups were balanced with baseline characteristics. This study showed a significantly reduced median transfusion time for a unit of red blood cell concentrate from 20min pre-protocol to 9min post-protocol. The time between patient's admission and transfusion of the first red blood cell concentrate was reduced but non-significantly from 71min to 36min. The major haemorrhage protocol optimised patient management by reducing the median transfusion time for red blood cell concentrates.

Management of Major Obstetric Haemorrhage using ROTEM Point-of-Care Haemostasis Analysers Can Reduce Blood Product usage Without Increasing Fibrinogen Replacement Therapy

Major obstetric haemorrhage (MOH) is a leading cause of maternal death and morbidity, with the majority of deaths occurring within four hours of delivery. Therefore, prompt identification of women at risk of MOH is crucial for the rapid assessment and management of blood loss to urgently restore haemodynamic stability. Furthermore, as the rate of blood loss during MOH can increase rapidly in the time when laboratory results are awaited, the management of MOH could benefit from point-of-care coagulation testing by the ROTEM analyser which has a quicker turnaround time compared to standard laboratory coagulation tests. A number of studies indicate that ROTEM-based management of MOH has resulted in a significant reduction in massive transfusions and decreased transfusion of concentrated red cells (CRC) and fresh frozen plasma (FFP) due to a reduction in total blood loss. Several reports which have linked MOH to the depletion of fibrinogen reserves indicate that the reduction in CRC and FFP transfusions is largely due to an increase in early fibrinogen replacement therapy which corrects hypofibrinogenemia. This short report discusses preliminary findings on the impact of ROTEM point-of-care haemostasis analyser on the transfusion of various blood products to obstetric women experiencing MOH at the Royal Gwent Hospital in South wales. The number of blood products transfused following decisions based on the ROTEM analyser measurements (ROTEM group) was compared to historical transfusion data before the ROTEM analyser became available (Pre-ROTEM group). Blood product transfusion in the Pre-ROTEM group was guided by measurements of standard laboratory coagulation tests in conjunction with the established major haemorrhage protocols at the time. The findings indicate that the ROTEM analyser was effective in managing MOH at point-of-care and led to a reduction in the transfusion of CRC, FFP and platelets. However, contrary to published studies, the reduction in blood product usage was not accompanied by an increase in fibrinogen replacement transfusion therapy, suggesting that the ROTEM’s FIBTEM assay accurately quantified fibrinogen levels based on fibrin-clot firmness to enable an early diagnosis of hypofibrinogenemia. Early establishment of the absence of hypofibrinogenemia helped to prevent unnecessary transfusion of fibrinogen concentrate in this study. These findings support the adoption of routine use of ROTEM analysers at point-of-care on labour wards to manage MOH and reduce fibrinogen replacement therapy. The ease of use and rapidity of ROTEM tests could enable departure from globally directed correction of coagulopathy during MOH to a more focussed and precise target transfusion therapy, which will ultimately reduce blood product wastage (including fibrinogen concentrate) whilst minimising transfusion-associated side effects such as alloimmunisation, circulatory overload and dilutional coagulopathy.

Early fibrinogen concentrate therapy for major haemorrhage in trauma (E-FIT 1): results from a UK multi-centre, randomised, double blind, placebo-controlled pilot trial

BackgroundThere is increasing interest in the timely administration of concentrated sources of fibrinogen to patients with major traumatic bleeding. Following evaluation of early cryoprecipitate in the CRYOSTAT 1 trial, we explored the use of fibrinogen concentrate, which may have advantages of more rapid administration in acute haemorrhage. The aims of this pragmatic study were to assess the feasibility of fibrinogen concentrate administration within 45 minutes of hospital admission and to quantify efficacy in maintaining fibrinogen levels ≥ 2 g/L during active haemorrhage.MethodsWe conducted a blinded, randomised, placebo-controlled trial at five UK major trauma centres with adult trauma patients with active bleeding who required activation of the major haemorrhage protocol. Participants were randomised to standard major haemorrhage therapy plus 6 g of fibrinogen concentrate or placebo.ResultsTwenty-seven of 39 participants (69%; 95% CI, 52–83%) across both arms received the study intervention within 45 minutes of admission. There was some evidence of a difference in the proportion of participants with fibrinogen levels ≥ 2 g/L between arms (p = 0.10). Fibrinogen levels in the fibrinogen concentrate (FgC) arm rose by a mean of 0.9 g/L (SD, 0.5) compared with a reduction of 0.2 g/L (SD, 0.5) in the placebo arm and were significantly higher in the FgC arm (p < 0.0001) at 2 hours. Fibrinogen levels were not different at day 7. Transfusion use and thromboembolic events were similar between arms. All-cause mortality at 28 days was 35.5% (95% CI, 23.8–50.8%) overall, with no difference between arms.ConclusionsIn this trial, early delivery of fibrinogen concentrate within 45 minutes of admission was not feasible. Although evidence points to a key role for fibrinogen in the treatment of major bleeding, researchers need to recognise the challenges of timely delivery in the emergency setting. Future studies must explore barriers to rapid fibrinogen therapy, focusing on methods to reduce time to randomisation, using ‘off-the-shelf’ fibrinogen therapies (such as extended shelf-life cryoprecipitate held in the emergency department or fibrinogen concentrates with very rapid reconstitution times) and limiting the need for coagulation test-based transfusion triggers.Trial registrationISRCTN67540073. Registered on 5 August 2015.