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The prevalence of hepatitis E virus (HEV) genotype 3 infections in the English population (including blood donors) is unknown, but is probably widespread, and the virus has been detected in pooled plasma products. HEV-infected donors have been retrospectively identified through investigation of reported cases of possible transfusion-transmitted hepatitis E. The frequency of HEV transmission by transfusion and its outcome remains unknown. We report the prevalence of HEV RNA in blood donations, the transmission of the virus through a range of blood components, and describe the resulting morbidity in the recipients. From Oct 8, 2012, to Sept 30, 2013, 225 000 blood donations that were collected in southeast England were screened retrospectively for HEV RNA. Donations containing HEV were characterised by use of serology and genomic phylogeny. Recipients, who received any blood components from these donations, were identified and the outcome of exposure was ascertained. 79 donors were viraemic with genotype 3 HEV, giving an RNA prevalence of one in 2848. Most viraemic donors were seronegative at the time of donation. The 79 donations had been used to prepare 129 blood components, 62 of which had been transfused before identification of the infected donation. Follow-up of 43 recipients showed 18 (42%) had evidence of infection. Absence of detectable antibody and high viral load in the donation rendered infection more likely. Recipient immunosuppression delayed or prevented seroconversion and extended the duration of viraemia. Three recipients cleared longstanding infection after intervention with ribavirin or alteration in immunosuppressive therapy. Ten recipients developed prolonged or persistent infection. Transaminitis was common, but short-term morbidity was rare; only one recipient developed apparent but clinically mild post-transfusion hepatitis. Our findings suggest that HEV genotype 3 infections are widespread in the English population and in blood donors. Transfusion-transmitted infections rarely caused acute morbidity, but in some immunosuppressed patients became persistent. Although at present blood donations are not screened, an agreed policy is needed for the identification of patients with persistent HEV infection, irrespective of origin, so that they can be offered antiviral therapy. Public Health England and National Health Service Blood and Transplant.

Haematoma expansion is a major cause of mortality in intracranial haemorrhage related to vitamin K antagonists (VKA-ICH). Normalisation of the international normalised ratio (INR) is recommended, but optimum haemostatic management is controversial. We assessed the safety and efficacy of fresh frozen plasma (FFP) versus prothrombin complex concentrate (PCC) in patients with VKA-ICH. We did an investigator-initiated, multicentre, prospective, randomised, open-label, blinded-endpoint trial. Patients aged at least 18 years with VKA-ICH who presented within 12 h after symptom onset with an INR of at least 2·0 were randomly assigned (1:1) by numbered sealed envelopes to 20 mL/kg of intravenous FFP or 30 IU/kg of intravenous four-factor PCC within 1 h after initial cerebral CT scan. The primary endpoint was the proportion of patients with INR 1·2 or lower within 3 h of treatment initiation. Masking of treatment was not possible, but the primary analysis was observer masked. Analyses were done using a treated-as-randomised approach. This trial is registered with EudraCT, number 2008-005653-37, and ClinicalTrials.gov, number NCT00928915. Between Aug 7, 2009, and Jan 9, 2015, 54 patients were randomly assigned (26 to FFP and 28 to PCC) and 50 received study drug (23 FFP and 27 PCC). The trial was terminated on Feb 6, 2015, after inclusion of 50 patients after a safety analysis because of safety concerns. Two (9%) of 23 patients in the FFP group versus 18 (67%) of 27 in the PCC group reached the primary endpoint (adjusted odds ratio 30·6, 95% CI 4·7–197·9; p=0·0003). 13 patients died: eight (35%) of 23 in the FFP group (five from haematoma expansion, all occurring within 48 h after symptom onset) and five (19%) of 27 in the PCC group (none from haematoma expansion), the first of which occurred on day 5 after start of treatment. Three thromboembolic events occurred within 3 days (one in the FFP group and two in the PCC group), and six after day 12 (one and five). 43 serious adverse events (20 in the FFP group and 23 in the PCC group) occurred in 26 patients. Six serious adverse events were judged to be FFP related (four cases of haematoma expansion, one anaphylactic reaction, and one ischaemic stroke) and two PCC related (ischaemic stroke and pulmonary embolism). In patients with VKA-related intracranial hemorrhage, four-factor PCC might be superior to FFP with respect to normalising the INR, and faster INR normalisation seemed to be associated with smaller haematoma expansion. Although an effect of PCC on clinical outcomes remains to be shown, our data favour the use of PCC over FFP in intracranial haemorrhage related to VKA. Octapharma.

Acute blood loss in trauma requires quick identification and action to restore circulating volume and save the patient. Massive transfusion protocols (MTPs) have become standard at Trauma Centers, in order to rapidly deliver blood products to bleeding patients. This literature review presents current standards of transfusion ratios, as well as insights into adjuncts during massive transfusions. PubMED was searched for articles from 2005 to 2020 on MTPs, the article were assessed for single vs. multi-institutional, mechanism of injury, type of MTP, timing in which blood products should be administered, timing of delivery of blood products to trauma bay, pre-hospital treatment and adjuncts, and outcomes. Eleven studies addressed transfusion ratios. Seven studies looked at timing of blood products. Nine studies addressed MTP pre-hospital treatment and adjuncts. Prior to 2015, studies supported the benefits of a balanced transfusion ratio, which was then confirmed by the PROPPR randomized controlled trial. The shorter the time to blood product delivery the better the outcomes. New advances in technology have allowed us to measure different patterns of coagulation, allowing more individualized approaches to the bleeding patient. Current massive transfusion protocols should utilize between 1:1:1 and 1:1:2 ratios of the 3 main products; plasma, platelets, and red blood cells. Massive transfusion protocols are effective in decreasing mortality. Better resuscitation efforts were seen when blood products were readily available in the trauma bay when the patient arrived and the faster the replacement of blood, the better the outcomes.

Millions of units of blood products are transfused annually to patients in the United States. Red blood cells are transfused to improve oxygen-carrying capacity in patients with or at high risk of developing symptomatic anemia. Restrictive transfusion thresholds with lower hemoglobin levels are typically clinically equivalent to more liberal thresholds. Transfusion of plasma corrects clinically significant coagulopathy in patients with or at high risk of bleeding. Mildly abnormal laboratory coagulation values are not predictive of clinical bleeding and should not be corrected with plasma. Transfused platelets prevent or treat bleeding in patients with thrombocytopenia or platelet dysfunction. Cryoprecipitate is transfused to treat hypofibrinogenemia. Many adverse reactions can occur during or after blood product transfusion. Transfusion-associated circulatory overload (i.e., volume overload) is the most common cause of mortality associated with blood products. Modifications to blood products can prevent or decrease the risks of transfusion-related adverse reactions. It is critical to quickly recognize when a reaction is occurring, stop the transfusion, assess, and support the patient. Reporting a reaction to the blood bank is part of ensuring patient safety and supporting hemovigilance efforts.

ObjectiveDespite lack of evidence supporting efficacy, prophylactic fresh frozen plasma and Octaplas transfusions may be administered to very preterm infants to reduce bleeding risk. International variation in plasma transfusion practices in neonatal intensive care units (NICUs) is poorly understood, therefore, we aimed to describe neonatal plasma transfusion practice in Europe.DesignProspective observational study.Setting64 NICUs in 22 European countries, with a 6-week study period per centre between September 2022 and August 2023.PatientsPreterm infants born below 32 weeks of gestational age.InterventionsAdmission to the NICU.Main outcome measuresPlasma transfusion prevalence, cumulative incidence, indications, transfusion volumes and infusion rates and adverse effects.ResultsA total of 92 of 1143 infants included (8.0%) received plasma during the study period, collectively receiving 177 transfusions. Overall prevalence was 0.3 plasma transfusion days per 100 admission days, and rates varied substantially across Europe. By day 28 of life, 13.5% (95% CI 10.0% to 16.9%) of infants received at least one plasma transfusion, accounted for competing risks of death or discharge. Transfusions were given for a broad range of indications, including active bleeding (29.4%), abnormal coagulation screen results (23.7%) and volume replacement/hypotension (21.5%). Transfusion volumes and infusion rates varied significantly; the most common volume was 15 mL/kg (range: 5–30 mL/kg) and the most common duration was 2 hours (range: 30 min to 6 hours).ConclusionsWe found wide variation in plasma transfusion practices in Europe, highlighting the need for evidence to inform neonatologists in daily practice and guidelines, in particular for non-bleeding indications.Trial registration numberISRCTN17267090.

Objective To determine the effectiveness of blood component therapy in the correction of trauma-induced coagulopathy during hemorrhage. Background Severe hemorrhage remains a leading cause of mortality in trauma. Damage control resuscitation strategies target trauma-induced coagulopathy (TIC) with the early delivery of high-dose blood components such as fresh frozen plasma (FFP) and platelet transfusions. However, the ability of these products to correct TIC during hemorrhage and resuscitation is unknown. Methods This was an international prospective cohort study of bleeding trauma patients at three major trauma centers. A blood sample was drawn immediately on arrival and after 4, 8 and 12 packed red blood cell (PRBC) transfusions. FFP, platelet and cryoprecipitate use was recorded during these intervals. Samples were analyzed for functional coagulation and procoagulant factor levels. Results One hundred six patients who received at least four PRBC units were included. Thirty-four patients (32 %) required a massive transfusion. On admission 40 % of patients were coagulopathic (ROTEM CA5 ≤ 35 mm). This increased to 58 % after four PRBCs and 81 % after eight PRBCs. On average all functional coagulation parameters and procoagulant factor concentrations deteriorated during hemorrhage. There was no clear benefit to high-dose FFP therapy in any parameter. Only combined high-dose FFP, cryoprecipitate and platelet therapy with a high total fibrinogen load appeared to produce a consistent improvement in coagulation. Conclusions Damage control resuscitation with standard doses of blood components did not consistently correct trauma-induced coagulopathy during hemorrhage. There is an important opportunity to improve TIC management during damage control resuscitation.

The aim of the study was to examine various haemostasis values to identify the most relevant biological indicators for detecting significant haemorrhage, to determine the effectiveness of fresh frozen plasma (FFP) transfusion. Our findings suggest that a low prothrombin time, elevated Von Willebrand Antigen, increased plasma fibrinogen, and reduced Ca2 + levels are associated with challenges in achieving proper haemostasis. However, measurements of factors II, V, VII, VIII, IX, X, XI, XIII, protein C, and protein S do not appear to be linked to difficulties in achieving adequate haemostasis. Additionally, the administration of FFP appears to impact factors V, VII, X, and II. Trial registration EudraCT number: 2019-002898-64.

Introduction Hemorrhage is the principal cause of death in the first few hours following severe injury. Coagulopathy is a frequent complication of critical bleeding. A network of Italian trauma centers recently developed a protocol to prevent and treat trauma-induced coagulopathy. A pre-post cohort multicenter study was conducted to assess the impact of the early coagulation support (ECS) protocol on blood products consumption, mortality and treatment costs. Methods We prospectively collected data from all severely injured patients (Injury Severity Score (ISS) >15) admitted to two trauma centers in 2013 and compared these findings with the data for 2011. Patients transfused with at least 3 units of packed red blood cells (PRBCs) within 24 hours of an accident were included in the study. In 2011, patients with significant hemorrhaging were treated with early administration of plasma with the aim of achieving a high (≥1:2) plasma-to-PRBC ratio. In 2013, the ECS protocol was the treatment strategy. Outcome data, blood product consumption and treatment costs were compared between the two periods. Results The two groups were well matched for demographics, injury severity (ISS: 32.9 in 2011 versus 33.6 in 2013) and clinical and laboratory data on admission. In 2013, a 40% overall reduction in PRBCs was observed, together with a 65% reduction in plasma and a 52% reduction in platelets. Patients in the ECS group received fewer blood products: 6.51 units of PRBCs versus 8.14 units. Plasma transfusions decreased from 8.98 units to 4.21 units ( P <0.05), and platelets fell from 4.14 units to 2.53 units ( P <0.05). Mortality in 2013 was 13.5% versus 20% in 2011 (13 versus 26 hospital deaths, respectively) (nonsignificant). When costs for blood components, factors and point-of-care tests were compared, a €76,340 saving in 2013 versus 2011 (23%) was recorded. Conclusions The introduction of the ECS protocol in two Italian trauma centers was associated with a marked reduction in blood product consumption, reaching statistical significance for plasma and platelets, and with a non-significant trend toward a reduction in early and 28-day mortality. The overall costs for transfusion and coagulation support (including point-of-care tests) decreased by 23% between 2011 and 2013.

The debate on replacing coagulation factors and its effect on the final outcome of the patients with acute traumatic coagulopathy (ATC) in need of transfusion is still ongoing. Therefore, the present study is designed with the aim of comparing the outcome of patients with acute traumatic coagulopathies receiving fibrinogen and fresh frozen plasma (FFP). In this quasi-experimental randomized controlled study, patients with severe blunt trauma (ISS>16) and in need of packed cells transfusion were divided into 3 groups of receiving fibrinogen, receiving FFP, and control, and their final outcome was compared. 90 patients with the mean age of 33.16±16.32years were randomly allocated to one of the 3 study groups (82.2% male). The 3 groups were similar regarding baseline characteristics. Patients receiving fibrinogen needed significantly less packed cells (p=0.044) and intravenous fluid in the initial 24h of hospitalization (p=0.022). In addition, mortality rate (p=0.029), need for admission to intensive care unit (p=0.020) and duration of hospitalization (p=0.045) were also lower in the group receiving fibrinogen. The number of sepsis cases in patients receiving fibrinogen and control group was lower than those who received FFP (p=0.001). The number of multiple organ failure cases in patients receiving fibrinogen was about one fourth of the other 2 groups (p=0.106), and a fewer number of them needed mechanical ventilation (p=0.191). No case of venous thrombosis was detected in any of the 3 groups. Multiple trauma patients in need of transfusion who received fibrinogen along with packed cells had significantly better outcomes regarding mortality, sepsis, need for admission to the intensive care unit, need for receiving packed cells, need for receiving intravenous fluids in the initial 24h, and duration of hospitalization.

Background Plasma transfusion is recommended as an initial intervention in most major haemorrhage protocols for trauma resuscitation. With availability of newer blood components, therapeutic agents and investigations for coagulopathy, the marginal benefits of high ratios of plasma to red cells is uncertain. The aim of this study was to report the association of high ratios of plasma: red cells and 28-day mortality in patients with major trauma. Methods The PATCH-Trauma trial enrolled critically bleeding patients at high risk of trauma induced coagulopathy and randomised them to receive prehospital tranexamic acid or placebo. The sub-group of patients who were managed with massive transfusions in hospital (> 4 units of red cells in first 4 h) were included for this post-hoc analysis. Associations of high ratios of plasma (more than 1 unit of plasma for every 2 units of red cells) and 28-day mortality were reported using multivariable logistic regression analysis after adjustment for potential confounders including age, neurological injury, injury severity, coagulopathy and administration of platelets, fibrinogen concentrates, cryoprecipitate and tranexamic acid. Results Among 1310 patients enrolled in the PATCH-trauma trial, 372 patients were included for this analysis; 213 (57.3%) received high ratios of plasma: red cells and 116 (31.4%) deaths were recorded at 28 days. High ratios of plasma: red cells were associated with lower mortality (adjusted odds ratio; aOR 0.50; 95%CI: 0.26–0.96). Older age (aOR 1.02; 95%CI: 1.01–1.03), initial Glasgow Coma Scale 3–8 (aOR 6.57; 95%CI: 2.92–14.80) and trauma induced coagulopathy (aOR 5.64; 95%CI: 2.87–11.1) on hospital arrival were associated with higher mortality. Conclusions Among patients with critical bleeding managed with massive transfusions, high ratios of plasma: red cells were associated with lower mortality, after controlling for potential confounders. Ongoing provision of early plasma for management of critical bleeding is indicated with consideration to prehospital plasma. Registration ClinicalTrials.gov number, NCT02187120 (Registered 09 July 2014).