Efficacy of standard dose and 30 ml/kg fresh frozen plasma in correcting laboratory parameters of haemostasis in critically ill patients.
TL;DR: Coagulation screens were poor predictors of coagulation factor levels and current guidelines on the use of FFP result in predictably small increments in coagulating factors in critically ill patients and should be reviewed.
Abstract: This study assessed the effect on coagulation tests of fresh frozen plasma (FFP), given according to guidelines compared with higher doses in critically ill patients. Group 1 (10 patients) received 12.2 ml/kg and group 2 (12 patients) 33.5 ml/kg FFP. Prothrombin time, activated partial thromboplastin time and factors I-XII were measured before and after FFP infusion. Factor levels of 30 IU/dl (1 g/l for fibrinogen) were considered haemostatic. A retrospective review showed 10 of 22 (five in group 1 and five in group 2) patients had not required FFP. Of those that needed FFP, one of five in group 1 and seven of seven in group 2 had coagulation factor levels above the target post-FFP. Increments for group 1 versus 2 were: fibrinogen 0.4 vs. 1.0 g/l, FII 16 vs. 41*, FV 10 vs. 28*, FVII 11 vs. 38*, FVIII 10 vs. 17, FIX 8 vs. 28*, FX 15 vs. 37*, FXI 9 vs. 23 and FXII 30 vs. 44 IU/dl* (*P < 0.01). In vivo recovery of coagulation factors was the same for both groups and the observed increments correlated with the dose of FFP. In conclusion, coagulation screens were poor predictors of coagulation factor levels and current guidelines on the use of FFP result in predictably small increments in coagulation factors in critically ill patients and should be reviewed.
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TL;DR: The guideline now recommends that patients be transferred directly to an appropriate trauma treatment centre and encourages use of a restricted volume replacement strategy during initial resuscitation, and may also serve as a basis for local implementation.
Abstract: Severe trauma continues to represent a global public health issue and mortality and morbidity in trauma patients remains substantial. A number of initiatives have aimed to provide guidance on the management of trauma patients. This document focuses on the management of major bleeding and coagulopathy following trauma and encourages adaptation of the guiding principles to each local situation and implementation within each institution. The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004 and included representatives of six relevant European professional societies. The group used a structured, evidence-based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale. Expert opinion and current clinical practice were also considered, particularly in areas in which randomised clinical trials have not or cannot be performed. Existing recommendations were reconsidered and revised based on new scientific evidence and observed shifts in clinical practice; new recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated. This guideline represents the fourth edition of a document first published in 2007 and updated in 2010 and 2013. The guideline now recommends that patients be transferred directly to an appropriate trauma treatment centre and encourages use of a restricted volume replacement strategy during initial resuscitation. Best-practice use of blood products during further resuscitation continues to evolve and should be guided by a goal-directed strategy. The identification and management of patients pre-treated with anticoagulant agents continues to pose a real challenge, despite accumulating experience and awareness. The present guideline should be viewed as an educational aid to improve and standardise the care of the bleeding trauma patients across Europe and beyond. This document may also serve as a basis for local implementation. Furthermore, local quality and safety management systems need to be established to specifically assess key measures of bleeding control and outcome. A multidisciplinary approach and adherence to evidence-based guidance are key to improving patient outcomes. The implementation of locally adapted treatment algorithms should strive to achieve measureable improvements in patient outcome.
1,247 citations
Cites background from "Efficacy of standard dose and 30 ml..."
...Administration of plasma to bleeding patients may stabilise fibrinogen levels, avoiding a further decrease, but plasma transfusions cannot contribute to a significant increase in fibrinogen level unless very high volumes are infused [406]....
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University of Copenhagen1, Centre Hospitalier Universitaire de Grenoble2, University of Valladolid3, University of Naples Federico II4, Innsbruck Medical University5, Ludwig Maximilian University of Munich6, Maastricht University7, University of Valencia8, Royal Lancaster Infirmary9, University of Salzburg10
TL;DR: These guidelines are intended to provide an overview of current knowledge on the subject with an assessment of the quality of the evidence in order to allow anaesthetists throughout Europe to integrate this knowledge into daily patient care wherever possible.
Abstract: The aims of severe perioperative bleeding management are three-fold. First, preoperative identification by anamesis and laboratory testing of those patients for whom the perioperative bleeding risk may be increased. Second, implementation of strategies for correcting preoperative anaemia and stabilisation of the macro- and microcirculations in order to optimise the patient’s tolerance to bleeding. Third, targeted procoagulant interventions to reduce the amount of bleeding, morbidity, mortality and costs. The purpose of these guidelines is to provide an overview of current knowledge on the subject with an assessment of the quality of the evidence in order to allow anaesthetists throughout Europe to integrate this knowledge into daily patient care wherever possible. The Guidelines Committee of the European Society of Anaesthesiology (ESA) formed a task force with members of scientific subcommittees and individual expert members of the ESA. Electronic databases were searched without language restrictions from the year 2000 until 2012. These searches produced 20 664 abstracts. Relevant systematic reviews with meta-analyses, randomised controlled trials, cohort studies, case-control studies and cross-sectional surveys were selected. At the suggestion of the ESA Guideline Committee, the Scottish Intercollegiate Guidelines Network (SIGN) grading system was initially used to assess the level of evidence and to grade recommendations. During the process of guideline development, the official position of the ESA changed to favour the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. This report includes general recommendations as well as specific recommendations in various fields of surgical interventions. The final draft guideline was posted on the ESA website for four weeks and the link was sent to all ESA members. Comments were collated and the guidelines amended as appropriate. When the final draft was complete, the Guidelines Committee and ESA Board ratified the guidelines.
883 citations
TL;DR: ROTEM®-guided haemostatic therapy, with fibrinogen concentrate as first-line haemOSTatic therapy and additional PCC, was goal-directed and fast, and a favourable survival rate was observed.
Abstract: The appropriate strategy for trauma-induced coagulopathy management is under debate. We report the treatment of major trauma using mainly coagulation factor concentrates. This retrospective analysis included trauma patients who received ≥ 5 units of red blood cell concentrate within 24 hours. Coagulation management was guided by thromboelastometry (ROTEM®). Fibrinogen concentrate was given as first-line haemostatic therapy when maximum clot firmness (MCF) measured by FibTEM (fibrin-based test) was 1.5 times normal. Lack of improvement in EXTEM MCF after fibrinogen concentrate administration was an indication for platelet concentrate. The observed mortality was compared with the mortality predicted by the trauma injury severity score (TRISS) and by the revised injury severity classification (RISC) score. Of 131 patients included, 128 received fibrinogen concentrate as first-line therapy, 98 additionally received PCC, while 3 patients with recent coumarin intake received only PCC. Twelve patients received FFP and 29 received platelet concentrate. The observed mortality was 24.4%, lower than the TRISS mortality of 33.7% (P = 0.032) and the RISC mortality of 28.7% (P > 0.05). After excluding 17 patients with traumatic brain injury, the difference in mortality was 14% observed versus 27.8% predicted by TRISS (P = 0.0018) and 24.3% predicted by RISC (P = 0.014). ROTEM®-guided haemostatic therapy, with fibrinogen concentrate as first-line haemostatic therapy and additional PCC, was goal-directed and fast. A favourable survival rate was observed. Prospective, randomized trials to investigate this therapeutic alternative further appear warranted.
591 citations
Cites background from "Efficacy of standard dose and 30 ml..."
...Chowdhury and colleagues showed that 12 mL per kg bodyweight did not sufficiently increase the concentration of the coagulation factors [45]....
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Case Western Reserve University1, Johns Hopkins University2, Mayo Clinic3, Harvard University4, Australian Catholic University5, University of Tennessee Health Science Center6, University of Kentucky7, University of Washington8, University of Pennsylvania9, Memorial Sloan Kettering Cancer Center10, New York Medical College11, Université de Montréal12, Martin Luther University of Halle-Wittenberg13, Centra14
TL;DR: This guideline provides timely, evidence-based reversal strategies to assist practitioners in the care of patients with antithrombotic-associated intracranial hemorrhage.
Abstract: The use of antithrombotic agents, including anticoagulants, antiplatelet agents, and thrombolytics has increased over the last decade and is expected to continue to rise. Although antithrombotic-associated intracranial hemorrhage can be devastating, rapid reversal of coagulopathy may help limit hematoma expansion and improve outcomes. The Neurocritical Care Society, in conjunction with the Society of Critical Care Medicine, organized an international, multi-institutional committee with expertise in neurocritical care, neurology, neurosurgery, stroke, hematology, hemato-pathology, emergency medicine, pharmacy, nursing, and guideline development to evaluate the literature and develop an evidence-based practice guideline. Formalized literature searches were conducted, and studies meeting the criteria established by the committee were evaluated. Utilizing the GRADE methodology, the committee developed recommendations for reversal of vitamin K antagonists, direct factor Xa antagonists, direct thrombin inhibitors, unfractionated heparin, low-molecular weight heparin, heparinoids, pentasaccharides, thrombolytics, and antiplatelet agents in the setting of intracranial hemorrhage. This guideline provides timely, evidence-based reversal strategies to assist practitioners in the care of patients with antithrombotic-associated intracranial hemorrhage.
524 citations
Cites background from "Efficacy of standard dose and 30 ml..."
...Although typical doses range from 5 to 20 mL/kg, a dose of 30 mL/kg produces more complete correction of coagulation factor levels [75–81]....
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TL;DR: TEM-guided haemostatic therapy with fibrinogen concentrate and PCC reduced the exposure of trauma patients to allogeneic blood products.
Abstract: Introduction
Thromboelastometry (TEM)-guided haemostatic therapy with fibrinogen concentrate and prothrombin complex concentrate (PCC) in trauma patients may reduce the need for transfusion of red blood cells (RBC) or platelet concentrate, compared with fresh frozen plasma (FFP)-based haemostatic therapy.
371 citations
Cites background from "Efficacy of standard dose and 30 ml..."
...Attempts to reduce FFP transfusion are complicated by the fact that small quantities of FFP are not effective in correcting coagulopathy [25,26]....
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References
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TL;DR: The risk of transmitting the human immunodeficiency virus (HIV), the human T-cell lymphotropic virus (HTLV), the hepatitis C virus (HCV), and the hepatitis B virus (HBV) from screened blood units donated during the window period following a recent, undetected infection is estimated.
Abstract: Background Accurate estimates of the risk of transfusion-transmitted infectious disease are essential for monitoring the safety of the blood supply and evaluating the potential effect of new screening tests. We estimated the risk of transmitting the human immunodeficiency virus (HIV), the human T-cell lymphotropic virus (HTLV), the hepatitis C virus (HCV), and the hepatitis B virus (HBV) from screened blood units donated during the window period following a recent, undetected infection. Methods Using data on 586,507 persons who each donated blood more than once between 1991 and 1993 at five blood centers (for a total of 2,318,356 allogeneic blood donations), we calculated the incidence rates of seroconversion among those whose donations passed all the screening tests used. We adjusted these rates for the estimated duration of the infectious window period for each virus. We then estimated the further reductions in risk that would result from the use of new and more sensitive viral-antigen or nucleic acid s...
1,757 citations
"Efficacy of standard dose and 30 ml..." refers background in this paper
...…FFP is important because blood product exposure is associated with significant adverse effects such as allergic reactions and volume overload and the potential risk of transmission of infectious agents, including variant Creutzfeldt-Jacob disease (Schreiber et al, 1996; Burthem & Roberts, 2003)....
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TL;DR: The principal conclusions of the task force are that red blood cell transfusions should not be dictated by a single hemoglobin "trigger" but instead should be based on the patient's risks of developing complications of inadequate oxygenation.
Abstract: In 1994, the American Society of Anesthesiologists established the Task Force on Blood Component Therapy to develop evidence‐based indications for transfusing red blood cells, platelets, fresh‐frozen plasma, and cryoprecipitate in perioperative and peripartum settings. The guidelines were developed according to an explicit methodology. The principal conclusions of the task force are that red blood cell transfusions should not be dictated by a single hemoglobin \"trigger\" but instead should be based on the patient's risks of developing complications of inadequate oxygenation. Red blood cell transfusion is rarely indicated when the hemoglobin concentration is greater than 10 g/dL and is almost always indicated when it is less than 6 g/dL. The indications for autologous transfusion may be more liberal than for allogeneic (homologous) transfusion. The risks of bleeding in surgical and obstetric patients are determined by the extent and type of surgery, the ability to control bleeding, the actual and anticipated rate of bleeding, and the consequences of uncontrolled bleeding. Prophylactic platelet transfusion is ineffective when thrombocytopenia is due to increased platelet destruction. Surgical and obstetric patients with microvascular bleeding usually require platelet transfusion if the platelet count is less than 50 x 109 /l and rarely require therapy if it is greater than 100 x 10 sup 9 /l. Fresh‐frozen plasma is indicated for urgent reversal of warfarin therapy, correction of known coagulation factor deficiencies for which specific concentrates are unavailable, and correction of microvascular bleeding when prothrombin and partial thromboplastin times are > 1.5 times normal. It is contraindicated for augmentation of plasma volume or albumin concentration. Cryoprecipitate should be considered for patients with von Willebrand's disease unresponsive to desmopressin, bleeding patients with von Willebrand's disease, and bleeding patients with fibrinogen levels below 80–100 mg/dL. The task force recommends careful adherence to proper indications for blood component therapy to reduce the risks of transfusion.
951 citations
TL;DR: Hemostatically effective levels of factor IX cannot be achieved, in most instances, by the conventional use of FFP in patients requiring reversal of their anticoagulant therapy and clotting factor concentrates are the only effective option where complete and immediate correction of the coagulation defect is indicated.
Abstract: Haemorrhage, including intracranial bleeding, is a common, potentially lethal complication of warfarin therapy and rapid and complete reversal of anticoagulation may be life-saving Fresh frozen plasma (FFP) and vitamin K are most frequently administered Because of the variable content of vitamin K-dependent clotting factors in FFP, and the effects of dilution, the efficacy of this approach is open to doubt We have therefore compared the effects of FFP and clotting factor concentrates on the INRs and clotting factor levels of orally anticoagulated subjects requiring rapid correction of their haemostatic defect In many, the pre-treatment INR was considered to be dangerously above the target therapeutic range In the 12 patients given FFP, the INR did not completely correct (range 16-38, mean 23) indicating an ongoing anticoagulated state in all In contrast, the INR in 29 subjects given clotting factor concentrates was completely corrected in 28 (range 09-38, mean 13) Following treatment, marked differences were observed in clotting factor IX levels between the two groups The median factor IX level was 19 u/dl (range 10-63) following FFP infusion and 685 u/dl (range 31-111) following concentrate In FFP treated patients, poorer responses were also observed for each of the other vitamin K-dependent clotting factors but these were less marked than for factor IX, which was present in low concentrations in some batches of FFP Thus, haemostatically effective levels of factor IX cannot be achieved, in most instances, by the conventional use of FFP in patients requiring reversal of their anticoagulant therapy Clotting factor concentrates are the only effective option where complete and immediate correction of the coagulation defect is indicated in orally anticoagulated patients with life or limb-threatening haemorrhage
388 citations
"Efficacy of standard dose and 30 ml..." refers background or result in this paper
...The low increments in coagulation factors observed in this study are in line with findings from studies on the reversal of warfarin, which showed that FFP given at a dose of about 12 ml/kg was only successful in raising factors II, VII, IX and X by between 9 and 14 IU/dl (Makris et al, 1997)....
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...This is an extrapolation of clinical experience from patients with inherited individual coagulation factor deficiencies (Bloom, 1994) and follows studies performed on the reversal of warfarin (Makris et al, 1997)....
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349 citations
TL;DR: The average LBT was 4 min 37 sec±3 min 48 sec (sd) in 10 patients, but their clotting indices were not different from those of other patients as mentioned in this paper.
Abstract: Contraindications for percutaneous liver biopsy are often derived arbitrarily from coagulation status of peripheral blood, but no objective data are available on the duration of bleeding from the site of liver biopsy. “Liver bleeding time” (LBT) was measured after liver biopsy had been performed at laparoscopy in 200 consecutive patients using a 1.8-mm-diameter Menghini needle. LBT was then analyzed in relation to prothrombin time, platelet count, whole blood clot time, length of biopsy cylinder, and liver histopathology. There was no correlation among any of these variables. The average LBT was 4 min 37 sec±3 min 48 sec (sd). In 10 patients LBT was prolonged over 12 min\((\bar X \pm 2SD)\), but their clotting indices were not different from those of other patients. Bleeding could be stopped easily by compression if necessary. This lack of correlation may be explained by the high concentration of clotting factors in hepatic parenchyma and by mechanical compression of the needle track by the elastic tissue in the liver. It is concluded that indices of coagulation in the peripheral blood used in this study are unreliable guides of the risk of bleeding after liver biopsy and, hence, are of limited value in determining contraindications to this procedure.
307 citations
"Efficacy of standard dose and 30 ml..." refers background in this paper
...Patients who are being managed in intensive care units (ICU) have multiple risk factors for developing abnormal coagulation tests although there is a poor correlation between coagulation screen results and risk of bleeding during invasive procedures (Ewe, 1981; Eisenberg et al, 1982)....
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...It is already recognized that coagulation screens are poor predictors of bleeding following invasive procedures (Ewe, 1981; Eisenberg et al, 1982)....
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