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Prothrombin complex concentrate in surgical patients: retrospective evaluation of vitamin K antagonist reversal and treatment of severe bleeding
Kerstin S Schick, Jan M Fertmann, Karl-Walter Jauch, Johannes N Hoffmann
Critical Care , 2009, DOI: 10.1186/cc8186
Abstract: The case notes of 50 patients requiring urgent oral anticoagulation reversal (n = 12) or with severe perioperative coagulopathic bleeding (n = 38) who received an infusion of prothrombin complex concentrate (Beriplex P/N(R) 500) at the surgical department of the University of Munich Hospital, Germany were retrospectively reviewed. Efficacy of prothrombin complex concentrate application was evaluated using the Quick test, reported as an international normalized ratio, hemodynamic measurements and requirement for blood products. Safety assessments included whole blood hemoglobin levels and specific parameters of organ dysfunction.Baseline characteristics were comparable, except that mean baseline international normalized ratio and hemoglobin levels were significantly higher (P < 0.01) in anticoagulation reversal than in bleeding patients. In anticoagulation reversal, the international normalized ratio was significantly reduced (from 2.8 +/- 0.2 at baseline to 1.5 +/- 0.1, P < 0.001) after one prothrombin complex concentrate infusion (median dose 1500 IU; lower quartile 1,000, upper quartile 2,000). No major bleeding was observed during surgery after prothrombin complex concentrate administration. Only one patient received platelets and red blood cell transfusion after prothrombin complex concentrate administration. In bleeding patients, infusion of prothrombin complex concentrate (median dose 2,000 IU; lower quartile 2,000, upper quartile 3,000) significantly reduced the INR from 1.7 +/- 0.1 at baseline to 1.4 +/- 0.1 (P < 0.001). This decrease was unrelated to fresh frozen plasma or vitamin K administration. Bleeding stopped after prothrombin complex concentrate administration in 4/11 (36%) patients with surgical bleeding and 26/27 (96%) patients with diffuse bleeding. Hemoglobin levels increased significantly from baseline in bleeding patients (P < 0.05) and mean arterial pressure stabilized (P < 0.05). No thrombotic events or changes in organ function were reported
Use of Prothrombin Complex Concentrate for Vitamin K Antagonist Reversal before Surgical Treatment of Intracranial Hemorrhage
Yun Wong
Clinical Medicine Insights: Case Reports , 2012, DOI: 10.4137/CCRep.S6433
Abstract: Background: Oral anticoagulant therapy (OAT) is used to prevent/treat thromboembolism. Major bleeding is common in patients on OAT; eg, warfarin increases intracranial hemorrhage (ICH) risk. Case: A 71-year-old male on warfarin (to reduce stroke risk) presented at Accident and Emergency Minor Injuries Unit with headache after reportedly sounding 'drunk'. On triage, the patient appeared lucid and well. However, International Normalized Ratio (INR) was 4.1. Head computed tomography (CT) indicated a large right-sided subdural hematoma. Prothrombin complex concentrate (PCC; Beriplex P/N, CSL Behring) with vitamin K normalized the INR within minutes of administration. The patient underwent neurosurgery without complications, and was discharged after 5 days, with no residual neurological symptoms. Conclusions: ICH patients can present with no neurological signs. In OAT patients with headache, INR must be established; if $3.0, normalization of INR and head CT are essential. PCC is the best option to rapidly reverse anticoagulation and correct INR pre-surgery.
Reversal of Vitamin K Antagonist (VKA) effect in patients with severe bleeding: a French multicenter observational study (Optiplex) assessing the use of Prothrombin Complex Concentrate (PCC) in current clinical practice
Thibaut Desmettre, Emilie Dehours, Charles-Marc Samama, Suchin Jhundoo, Frédéric Pujeau, Christian Guillaudin, Claudine Hecquart, Pierre Clerson, Jean Crave, Roland Jaussaud
Critical Care , 2012, DOI: 10.1186/cc11669
Abstract: All consecutive patients with VKA-related bleeding treated with a 4-factor PCC (Octaplex?) were selected in 33 French hospitals. Collected data included demographics, site and severity of bleeding, modalities of PCC administration, International Normalized Ratio (INR) values before and after PCC administration, outcomes and survival rate 15 days after infusion.Of 825 patients who received PCC between August 2008 and December 2010, 646 had severe bleeding. The main haemorrhage sites were intracranial (43.7%) and abdominal (24.3%). Mean INR before PCC was 4.4 ± 1.9; INR was unavailable in 12.5% of patients. The proportions of patients who received a PCC dose according to guidelines were 15.8% in patients with initial INR 2-2.5, 41.5% in patients with INR 2.5-3, 40.8% in patients with INR 3-3.5, 26.9% in patients with INR > 3.5, and 63.5% of patients with unknown INR. Vitamin K was administered in 84.7% of patients. The infused dose of PCC did not vary with initial INR; the mean dose was 25.3 ± 9.8 IU/Kg. Rates of controlled bleeding and target INR achievement were similar, regardless of whether or not patients were receiving PCC doses as per the guidelines. No differences in INR after PCC treatment were observed, regardless of whether or not vitamin K was administered. INR was first monitored after a mean time frame of 4.5 ± 5.6 hours post PCC. The overall survival rate at 15 days after PCC infusion was 75.4% (65.1% in patients with intracranial haemorrhage). A better prognosis was observed in patients reaching the target INR.Severe bleeding related to VKA needs to be better managed, particularly regarding the PCC infused dose, INR monitoring and administration of vitamin K. A dose of 25 IU/kg PCC appears to be efficacious in achieving a target INR of 1.5. Further studies are required to assess whether adjusting PCC dose and/or better management of INR would improve outcomes.Vitamin K antagonists (VKAs) are oral anticoagulants that inhibit liver production of vitamin
Prothrombin Complex Concentrate for Rapid Reversal of Warfarin Anticoagulation to Allow Neuraxial Blockade  [PDF]
Conor Skerritt,Stephen Mannion
Case Reports in Anesthesiology , 2014, DOI: 10.1155/2014/126864
Abstract: The development of Prothrombin Complex Concentrates (PCCs) has led to better outcomes in patients receiving emergency reversal of warfarin. However, most published data describes the use of PCCs in the setting of major bleeding or emergent major surgery, with little information on neuraxial blockade. We describe a case of rapid warfarin reversal using PCC and subsequent surgery under spinal anaesthesia in an 87-year-old lady, for whom general anaesthesia was deemed high risk. Her international normalised ratio (INR) on the morning of surgery was 1.8, precluding neuraxial blockade; however, it was felt that given, the need for imminent surgery, immediate reversal of the warfarin was indicated. We administered a single dose of 23?units/kg PCC and 5?mg vitamin K. Her INR 1 hour following PCC was 1.2, and spinal anesthetic was administered. The patient then underwent excision of melanoma deposits from her leg and groin dissection. There were no complications, the patient recovered satisfactorily, and there were no thrombotic or hemorrhagic events at 30 days postoperatively. This case study demonstrates a novel use of PCCs; in certain patients, PCCs may be safely used for immediate reversal of warfarin to allow for neuraxial blockade, safer anaesthesia, and better outcomes. 1. Introduction The development of Prothrombin Complex Concentrates (PCCs) has led to better outcomes in patients receiving emergency reversal of warfarin anticoagulation [1–4]. However, most of the published data describes the use of PCCs in the setting of major bleeding or emergent major abdominal surgery, with a dearth of information on neuraxial blockade. We describe a case of rapid warfarin reversal using PCC and subsequent surgery under spinal anaesthesia, with a good surgical outcome and no thrombotic or haemorrhagic events at 30 days. 2. Case/Methods An 87-year-old lady was scheduled for urgent palliative removal of malignant melanoma and satellite lesions from her lower leg and ipsilateral groin dissection for metastatic disease. Her background history included atrial fibrillation which was rate controlled (digoxin) and required anticoagulation (warfarin). Her background also included mitral regurgitation, hypertension, and hypothyroidism. As her mobility was severely limited by osteoarthritis of the hip, it was difficult to clinically establish her exercise tolerance, and it was decided that she would be more suitable for neuraxial blockade than general anaesthesia. She was instructed to discontinue warfarin for 4 days prior to her planned surgery, which she did. However, on the
Goal-directed coagulation management of major trauma patients using thromboelastometry (ROTEM?)-guided administration of fibrinogen concentrate and prothrombin complex concentrate
Herbert Sch?chl, Ulrike Nienaber, Georg Hofer, Wolfgang Voelckel, Csilla Jambor, Gisela Scharbert, Sibylle Kozek-Langenecker, Cristina Solomon
Critical Care , 2010, DOI: 10.1186/cc8948
Abstract: 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 <10 mm. Prothrombin complex concentrate (PCC) was given in case of recent coumarin intake or clotting time measured by extrinsic activation test (EXTEM) >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.Coagulopathy has been shown to be present in approximately 25 to 35% of all trauma patients on admission to the emergency room (ER) [1,2]. This represents a serious problem for major trauma patients and accounts for 40% of all trauma-related deaths [3]. Coagulopathy forces a strategy of early and rapid haemostatic treatment to prevent exsanguination. F
Superiority of Prothrombin Complex Concentrate versus Frozen Fresh Plasma in Cardiology Patients with Warfarin Intoxication–Observational Study  [PDF]
Alexandre de Matos Soeiro, Maria Cristina César, Bruno Biselli, Aline Siqueira Bossa, T. de Carvalho Andreucci Torres Leal, Maria Carolina Feres de Almeida Soeiro, Carlos V. Serrano, Ludhmila Abra?o Hajjar, Múcio Tavares Oliveira
Open Journal of Emergency Medicine (OJEM) , 2017, DOI: 10.4236/ojem.2017.52007
Abstract: Objective: The objective of this study was to analyse the reversibility of the anticoagulant effect of warfarin by comparing prothrombin complex concentrate (PCC) versus frozen fresh plasma (FFP) in cardiology patients with serious warfarin intoxication. Methods: This was an observational and retrospective study comprising 67 patients (18 in group I [PCC] and 49 in group II [FFP]). The primary endpoint was the reversal of anticoagulant effect of warfarin after 2 and 24 hours of PCC or FFP administration. Comparisons between the groups were made using T-test and Q-square. Multivariate analyses were conducted using logistic regression, and the results were considered significant when p < 0.05. Complementary analysis was performed using the ROC curve, calculating the area under the curve (AUC), and calculating the cut-off score for the relation between PCC (UI/kg) or FFP (ml/kg) and INR reversibility. Results: The medium dose used was 27.6 UI/kg of PCC and 14.5 ml/kg of FFP. Significant differences were observed between groups I and II in the INR reversibility measurements after 2 hours (33.3% vs. 6.1%, p = 0.001) and 24 hours (38.9% vs. 12.2%, p = 0.009) as well as in the occurrence of pulmonary edema (5.6% vs. 42.9%, OR = 11.10, p = 0.04). The AUC for PCC was 0.891 (CI 95% [0.72 - 1.0]), and for FFP, it was 0.291 (CI 95% [0.09 - 0.49]). Conclusions: PCC is better than FFP treatment in reversing the warfarin intoxication after 2 and 24 hours of administration. Furthermore, PCC showed lower pulmonary edema in cardiology patients.
ROTEM?-guided coagulation factor concentrate therapy in trauma: 2-year experience in Venice, Italy
Alberto Grassetto, Marco De Nardin, Bernadetta Ganzerla, Monica Geremia, Debora Saggioro, Elena Serafini, Silvia Zampieri, Manuela Toffoli, Daniele Penzo, Antonio Bossi, Carlo Maggiolo
Critical Care , 2012, DOI: 10.1186/cc11322
Abstract: In contrast to fixed-ratio treatment, coagulation factor concentrate therapy guided by point-of-care monitoring allows patients' actual needs to be targeted [3]. Our initial experience with ROTEM? (Tem International GmbH, Munich, Germany) indicated correlation between the clinical condition and extent of coagulopathy, suggesting a need for the early identification and treatment of coagulopathy that ROTEM? enables. Altogether, these factors provided a rationale for implementing ROTEM?-guided therapy for trauma patients in our hospital.In our experience, this approach is feasible and can replace formula-driven treatment. We found that coagulation factor concentrates (fibrinogen concentrate and prothrombin complex concentrate) correct coagulopathy effectively and rapidly, indicated by normalisation of ROTEM? parameters among bleeding trauma patients (Table 1). European guidelines for managing trauma raised the target fibrinogen concentration to 1.5 to 2 g/l [4], which we find difficult to reach without using fibrinogen concentrate. Without a comparator group, our data are insufficient to show reduced red blood cell transfusion or improvements in morbidity/mortality. However, we did see a progressive reduction in fresh frozen plasma consumption. Another advantage of using a ROTEM?-guided approach is the opportunity to detect hyperfibrinolysis. As reported elsewhere, we found that fulminant hyperfibrinolysis is associated with high mortality. Fulminant hyperfibrinolysis may potentially be considered the last gasp of the coagulation system; it may be a marker not only of severe coagulopathy, but also of poor clinical outcome. Our experience also suggests that patients with massive bleeding may benefit from immediate, proactive administration of 1 g tranexamic acid followed by 2 to 4 g fibrinogen concentrate, with further doses as soon as ROTEM? results are available.Fibrinogen concentrate is currently imported in Italy and we use it according to the manufacturer's label.
Prothrombin time in retinitis pigmentosa
Vinchurkar Manisha
Indian Journal of Ophthalmology , 1998,
Abstract: The prothrombin time was recorded for 87 primary retinitis pigmentosa (RP) patients belonging to three different clinical categories. All categories showed prothrombin time higher than normal. There was no correlation between the age of onset and the prothrombin time, nor between duration of disease and the prothrombin time. The high prothrombin time in patients with RP suggests that further study of prothrombin time and related factors may help in better understanding of the pathogenesis of RP.
The progress of prothrombin time measurement
Juha Eero Horsti
Hematology Reports , 2009, DOI: 10.4081/hr.2009.e19
Abstract: Warfarin is the most widely used medicine for oral anticoagulant therapy (OAT). It inhibits the synthesis of coagulation factors II, VII, IX, and X in the liver and results in the production of inactive or partially active versions of these factors. Inactive coagulation factors interfere with prothrombin time measurement (Quick and Owren PT) measuring the sum of coagulation activity and inhibition. The narrow therapeutic range here involves a danger of serious complications and the risk of bleeding or thrombosis. The new-generation PT method can measure coagulation activity and inhibition separately. This new technique promotes patient care and anticoagulant medication (warfarin, dicoumarol) based on coagulation activity in vivo. Both therapy and laboratory controls should be unquestionably accurate and based solely on in vivo coagulation activity. Inactive coagulation factors (inhibition) render measurement, calibration, and harmonization. The use of the new-generation PT method based on measurement of coagulation activity in vivo could develop vitamin K antagonist (VKA) therapy for the marked benefit of patients.
Epidemiological Clinical Features and Evolution of Gastroduodenal Ulcer Bleeding in a Tertiary Care Hospital in Spain, during the Last Seven Years  [PDF]
Eugenia Lauret,Jesús Herrero,Lorena Blanco,Olegario Casta?o,Maria Rodriguez,Isabel Pérez,Verónica Alvarez,Adolfo Suárez,Luis Rodrigo
Gastroenterology Research and Practice , 2013, DOI: 10.1155/2013/584540
Abstract: Background. Gastroduodenal ulcer bleeding is a common medical emergency. The aim of this study was to analyze the characteristics of bleeding episodes and to identify changes in the clinical trends over seven years. Methods. Retrospective observational clinical study on a cohort of 272 consecutive adult patients with peptic ulcer bleeding, during the 2006–2012 period. Results. Mean annual admission rate was 12.8 per 100.000 inhabitants. Men were predominant (71%), with a mean age of 66.6 years. Comorbidities were present in 131 cases (48.2%) and 156 patients (57.4%) had received ulcerogenic drugs. Duodenal ulcer was the commonest location (61%). Endoscopic therapy was necessary in 183 cases (67.3%) and rebleeding occurred in 30 patients (11%). Overall mortality rate was 5.5%, with a significant association with the presence of comorbidities ( ). There were no differences in trends of annual hospitalization, clinical features at presentation, and outcomes during this 7-years period. Conclusions. Annual hospitalization rates and prognosis of peptic ulcer bleeding have remained unchanged in the study period. This may be due to the fact that the effect of improved approach on this condition is probably counteracted by risk factors such as older age, severe comorbidities, and ulcerogenic drugs consumption, which have also remained stable over recent years. 1. Introduction Peptic ulcer bleeding remains a major clinical problem in the emergency setting, in Western countries. During the last decades, mortality rates from this gastrointestinal disorder have been reported to be stable, ranging between 5% and 15% worldwide [1, 2]. Despite increased knowledge about this condition, the use of improved diagnostics tools, the great advances in endoscopic therapy, and the routine use of ulcer treatment with proton pump inhibitors (PPIs) as well as eradication therapies against Helicobacter pylori, the published data on the changes in incidence and mortality for ulcer hemorrhage have been divergent [3–6]. In the nationwide population-based time-trend studies, a decline in general hospitalization rates was described over time, except among the elderly [4, 5]. By contrast, in regional population-based studies, the incidence of peptic ulcer bleeding was found unchanged [6]. The growing elderly population with presence of comorbidities and the gradual increase in prescription number of low-dose aspirin (ASA), nonsteroidal anti-inflammatory drugs (NSAID), and other antiplatelet or anticoagulant drugs have been recognized as some of the reasons for the expected changes on
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