scholarly journals Indications, Efficacy and Complications of Kcentra Use in Reversing Coagulopathy

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3820-3820 ◽  
Author(s):  
Nithya Sritharan ◽  
Darrell Triulzi
Keyword(s):  
Deep Vein Thrombosis ◽  
Ischemic Stroke ◽  
Adverse Events ◽  
Conflicts Of Interest ◽  
Oral Anticoagulants ◽  
Coagulation Factor ◽  
Invasive Procedure ◽  
Vein Thrombosis ◽  
Urgent Surgery ◽  
Deep Vein

Abstract Introduction Direct acting oral anticoagulants are rapidly replacing warfarin, the most commonly used anticoagulant for patients with atrial fibrillation, pulmonary embolism (PE) and deep vein thrombosis (DVT). However, there is limited data on the efficacy and adverse effects of the commercial Kcentra used in these patients. Kcentra, the only approved PCC in the USA, is FDA approved for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure. In this study we examine the indications for administration of Kcentra, efficacy of the PCC in several coagulopathies, incidence of adverse events including ischemic stroke and DVT/ PE, and overall mortality. Methods Retrospective analysis of inpatients at UPMC Presbyterian, Shadyside and Mercy, admitted between February 2016 and 2017 was done. A total of 213 patients, with history of stroke / DVT / PE who received Kcentra were grouped based on the cause of coagulopathy, sites of bleed (CNS or non-CNS) or the clinical setting of Kcentra administration. Definitions of the International Society on Thrombosis and Hemostasis (ISTH) / Scientific and Standardization Committee were used to assess the efficacy of management. Among the patients on Warfarin, only non-CNS and prophylactic administration group were included here as those with CNS bleeding were part of an earlier study. Adverse events measured were incidence of ischemic stroke and DVT/ PE during their hospital stay. Results The 213 patients who received Kcentra included those on warfarin (40%), apixaban (21%), Rivaroxaban (23%), with the remaining 16% including patients with hepatic cirrhosis, disseminated intravascular coagulation and those with coagulopathy related to heparin/ fondaparinux or antiplatelets (ASA, clopidogrel). The study group included those with CNS bleeds (33%), non-CNS bleeds (37%) and those in the prophylactic, pre-operative setting (30%). The majority of the non-CNS bleeds were patients with gastrointestinal bleeding (45%), with the rest including the musculoskeletal (31%) and intra-abdominal / intra-thoracic (16%) bleeding. Mortality was highest in patients with cirrhosis (n = 15), DIC (n = 8), and on anti-platelet medications (n = 2) at 100%, followed by 60% in patients on heparin / fondaparinux (n = 5). The mortality was markedly lower (~13%) in patients on Coumadin, Apixaban and Rivaroxaban. 2 of the patients, previously on rivaroxaban, developed multiple CNS infarcts. Thromboembolic events were significantly higher (40%) in patients with cirrhosis, with moderate effect in the Rivaroxaban group (14.5%) when compared to coumadin (2.3%) and apixaban (0%). Conclusions Kcentra was used in several off-label clinical settings, with comparable mortality among the coumadin, rivaroxaban and apixaban groups and no identifiable benefit in the setting of cirrhosis, DIC or antiplatelet medications, but with an increased incidence of deep vein thrombosis and stroke. Disclosures No relevant conflicts of interest to declare.

Trial of Aspirin and RA 233 in Prevention of Post-operative Deep Vein Thrombosis

1973 ◽  
Vol 30 (01) ◽  
pp. 018-024 ◽  
Author(s):  
Edward H. Wood ◽  
Colin R.M. Prentice ◽  
D. Angus McGrouther ◽  
John Sinclair ◽  
George P. McNicol
Keyword(s):  
Deep Vein Thrombosis ◽  
Controlled Trial ◽  
Oral Anticoagulants ◽  
Antithrombotic Agent ◽  
Fractured Neck Of Femur ◽  
Neck Of Femur ◽  
Vein Thrombosis ◽  
Effective Prophylaxis ◽  
Deep Vein ◽  
Calf Vein

SummaryAlthough the oral anticoagulants provide effective prophylaxis against postoperative deep vein thrombosis following fracture of neck of femur there is a need for an antithrombotic agent which needs less laboratory control and does not cause haemorrhagic complications. It has been suggested that drugs causing inhibition of platelet function may fulfil these requirements. A controlled trial was carried out in which aspirin, RA 233, or a combination of these drugs was compared with a placebo in the prevention of post-operative deep vein thrombosis. In thirty patients undergoing surgery for fractured neck of femur the incidence of post-operative calf vein thrombosis, as detected by 125I-fibrinogen scanning, was not significantly different between the untreated and treated groups.

Intensive Initial Oral Anticoagulation and Shorter Heparin Treatment in Deep Vein Thrombosis

1984 ◽  
Vol 52 (03) ◽  
pp. 276-280 ◽  
Author(s):  
Sam Schulman ◽  
Dieter Lockner ◽  
Kurt Bergström ◽  
Margareta Blombäck
Keyword(s):  
Deep Vein Thrombosis ◽  
Oral Anticoagulation ◽  
Dose Group ◽  
Low Dose ◽  
Clinical Signs ◽  
Coagulation Factor ◽  
High Dose ◽  
Vein Thrombosis ◽  
Heparin Treatment ◽  
Deep Vein

SummaryIn order to investigate whether a more intensive initial oral anticoagulation still would be safe and effective, we performed a prospective randomized study in patients with deep vein thrombosis. They received either the conventional regimen of oral anticoagulation (“low-dose”) and heparin or a more intense oral anticoagulation (“high-dose”) with a shorter period of heparin treatment.In the first part of the study 129 patients were randomized. The “low-dose” group reached a stable therapeutic prothrombin complex (PT)-level after 4.3 and the “high-dose” group after 3.3 days. Heparin was discontinued after 6.0 and 5.0 days respectively. There was no difference in significant hemorrhage between the groups, and no clinical signs of progression of the thrombosis.In the second part of the study another 40 patients were randomized, followed with coagulation factor II, VII, IX and X and with repeated venograms. A stable therapeutic PT-level was achieved after 4.4 (“low-dose”) and 3.7 (“high-dose”) days, and heparin was discontinued after 5.4 and 4.4 days respectively. There were no clinical hemorrhages, the activity of the coagulation factors had dropped to the same level in both groups at the time when heparin was discontinued and no thromboembolic complications occurred.Our oral anticoagulation regimen with heparin treatment for an average of 4.4-5 days seems safe and reduces in-patient costs.

Congenital Antithrombin III Deficiency in 3 Families (7 Affected Members)

1979 ◽  
Author(s):  
J. Conard ◽  
M. Samama ◽  
M. H. Horellou ◽  
B. Cazenave ◽  
P. Griguer ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Antithrombin Iii ◽  
Oral Anticoagulants ◽  
Vena Cava ◽  
Oral Contraception ◽  
Vein Thrombosis ◽  
Heparin Treatment ◽  
At Iii ◽  
Antithrombin Iii Deficiency ◽  
Deep Vein

A congenital Antithrombin III (AT III) deficiency affecting 7 members of 3 families is reported.The first throrabo-embolic accidents were observed between the age of 22 and 35 : they were spontaneous or occured after delivery or oral contraception. in one patient, a deep vein thrombosis was observed during heparin treatment. in 2 cases, recurrent pulmonary embolic episodes required vena cava ligation. No thromboembolic accident was observed during oral anticoagulation.AT III was measured by an amidolytic method and by the Mancini method on plasma and serum ; the antithrombin activity was determined on serum by the von Kaulla method. in 7 patients, a decreased AT III was found by all the methods performed. The AT III level was around 50 % in patients treated or not by oral anticoagulants One patient was studied during heparin treatment and then under oral anticoagulants : AT III levels were lower under heparin.

scholarly journals Apixaban Anti-Xa Level Monitoring in Treatment of Provoked Acute Upper Extremity Deep Vein Thrombosis for Patient on Dialysis: A Case Report

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 14-14
Author(s):  
Guillaume Roberge ◽  
Philip S. Wells
Keyword(s):  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Upper Extremity ◽  
Conflicts Of Interest ◽  
Subcutaneous Fat ◽  
Chronic Hemodialysis ◽  
Vein Thrombosis ◽  
Acute Venous Thromboembolism ◽  
Deep Vein ◽  
Trough Levels

Background. Patients with end stage renal disease on dialysis are at higher risk of major bleeding and recurrent thrombosis and as such, treatment of acute venous thromboembolism (VTE) is challenging. Ideally, treatment would avoid inpatient admission as for most other patients with acute VTE. DOACs represent the easiest option but there are concerns over bioaccumulation increasing bleeding risk. Despite the absence of a standardized therapeutic range, anti-Xa trough level is measured to monitor potential DOACs bioaccumulation and thus, used for safety surveillance. Methods. We describe a case of a 51 yo female, 36 kg, on chronic hemodialysis with a provoked acute upper extremity deep vein thrombosis. Due to a lack of subcutaneous fat and calciphylaxis we were reluctant to use low molecular weight heparin and warfarin. She was treated with apixaban 2,5 mg twice daily for 6 weeks. Over 4 weeks, the apixaban anti-Xa trough levels were measured on dialysis days 12 hours after the morning dose. Results. The anti-Xa trough levels ranged from 58 to 84 ng/mL, similar to what is expected in patients with normal kidney function. There were no adverse events in the 3 months after anticoagulation initiation. Conclusion. We saw no evidence of bioaccumulation. This indicates a potential role for apixaban low doses in acute venous thromboembolism for patients on dialysis. Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: The use of Apixaban for treatment of acute venous thromboembolism in patient on dialysis has not been approved.

scholarly journals Estimating the risk of thrombotic events in people with congenital hemophilia A using US claims data

2021 ◽  
Author(s):  
Imi Faghmous ◽  
Francis Nissen ◽  
Peter Kuebler ◽  
Carlos Flores ◽  
Anisha M Patel ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Ischemic Stroke ◽  
Hemophilia A ◽  
Incidence Rates ◽  
Thrombotic Risk ◽  
Vein Thrombosis ◽  
Deep Vein ◽  
Similar Incidence

Aim: Compare thrombotic risk in people with congenital hemophilia A (PwcHA) to the general non-hemophilia A (HA) population. Patients & methods: US claims databases were analyzed to identify PwcHA. Incidence rates of myocardial infarction, pulmonary embolism, ischemic stroke, deep vein thrombosis and device-related thrombosis were compared with a matched cohort without HA. Results: Over 3490 PwcHA were identified and 16,380 individuals matched. PwcHA had a similar incidence of myocardial infarction and pulmonary embolism compared with the non-HA population, but a slightly higher incidence of ischemic stroke and deep vein thrombosis. The incidence of device-related thrombosis was significantly higher in PwcHA. Conclusion: This analysis suggests that PwcHA are not protected against thrombosis, and provides context to evaluate thrombotic risk of HA treatments.

Analysis of therapy effectiveness of deep vein thrombosis of lower limbs with warfarin and rivaroxaban in the long-term period

2020 ◽  
Author(s):  
А.А. Полянцев ◽  
Д.В. Фролов ◽  
Д.В. Линченко ◽  
Ю.В. Щелокова ◽  
Т.А. Литвинова ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Oral Anticoagulants ◽  
Lower Limbs ◽  
Prophylactic Regimen ◽  
Therapy Regimen ◽  
Vein Thrombosis ◽  
Group 2 ◽  
Deep Vein ◽  
Group 1

Введение. Влияние стандартной и альтернативных схем антикоагулянтной терапии на степень и скорость реканализации глубоких вен привлекает внимание современных исследователей. Цель исследования: сравнение эффективности терапии тромбоза глубоких вен (ТГВ) нижних конечностей варфарином и ривароксабаном в отдаленном периоде. Материалы и методы. В исследование включено 94 пациента с ТГВ нижних конечностей, которые были разделены на 2 группы в зависимости от назначенной схемы лечения. Средний возраст 50 пациентов группы 1 составил 44,0 12,6 лет, 44 больных группы 2 39,5 11,7 лет. Пациентам группы 1 был назначен варфарин, группы 2 ривароксабан в течение 6 мес после выписки. Конечная точка наблюдения 4 года. Результаты. Прием антикоагулянта ранее установленного срока прекратили 18 (36) пациентов из группы 1 и 2 (4,5) пациента из группы 2. Режим эластической компрессии в обеих группах пациенты соблюдали нерегулярно. Рецидив венозных тромбоэмболических осложнений в группе 1 отмечен в 11 (22) случаях, в группе 2 у 7 (15,9) пациентов. Отрицательная динамика ультразвукового обследования складывалась у пациентов обеих групп: у 16 пациентов группы 1 и у 9,1 группы 2 появились признаки поражения ранее неизмененных вен или окклюзия ранее проходимой вены после перенесенного тромбоза без клиники острого венозного тромбоза в анамнезе. Трофические расстройства отмечены у одного пациента группы 2 и у 1/3 пациентов группы 1 к четвертому году наблюдения. Значимые отличия между группами были получены по таким параметрам, как приверженность к лечению и степень тяжести венозной недостаточности, оцениваемая клинически, в пользу ривароксабана. Заключение. Неудовлетворительные результаты лечения при использовании стандартной схемы терапии ТГВ требуют назначения препаратов из группы новых оральных антикоагулянтов с возможным внедрением схемы профилактического приема. Introduction. Effect of standard and alternative anticoagulant therapy regimens on the degree and rapidity of deep vein recanalization attracts the attention of modern researchers. Aim: to compare the treatment effectiveness of deep vein thrombosis (DVT) of lower limbs with warfarin and rivaroxaban in the long-term period. Materials and methods. The study included 94 patients with DVT of lower limbs they were divided into 2 groups depending on the prescribed treatment regimen. The average age of 50 patients of group 1 was 44.0 12.6 years, 44 patients of group 2 39.5 11.7 years. Warfarin was prescribed to patients of group 1, rivaroxaban to patients of group 2 treatment was prescribed for 6 months after discharge. The endpoint of observation was 4 years. Results. 18 (36) patients from group 1 and 2 (4.5) patients from group 2 stopped taking the anticoagulant earlier than target date. Elastic compression treatment patients in both groups kept irregularly. Recurrence of venous thromboembolic complications in group 1 was noted in 11 (22) cases, in group 2 in 7 (15.9) patients. The negative ultrasound dynamics was observed in patients of both groups: 16 of patients in group 1 and 9.1 in group 2 had lesion signs of previously unchanged veins or occlusion of a previously passable vein after thrombosis without clinic of acute venous thrombosis. Trophic disorders were identified in 1 patient in group 2 and in 1/3 of patients in group 1 by the 4th year of observation. Significant differences between the groups were obtained in favor of rivaroxaban according to such parameters as adherence to treatment and the severity of venous insufficiency. Conclusion. Unsatisfactory results of DVT treatment with standard therapy regimen require the administration of new oral anticoagulants with the possible introduction of prophylactic regimen.

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