GUIDELINE for ANTITHROMBOTIC REVERSAL Table 1
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Effectiveness of Preemptive Antifibrinolysis with Tranexamic Acid
Lei et al. BMC Musculoskeletal Disorders (2020) 21:465 https://doi.org/10.1186/s12891-020-03488-8 STUDY PROTOCOL Open Access Effectiveness of preemptive antifibrinolysis with tranexamic acid in rheumatoid arthritis patients undergoing total knee arthroplasty: a study protocol for a randomized controlled trial Yiting Lei1†, Jiacheng Liu1†, Xi Liang1, Ning Hu1, Fuxing Pei2 and Wei Huang1* Abstract Background: Patients with rheumatoid arthritis (RA) who have undergone total knee arthroplasty are at increased risk of requiring a blood transfusion. This study is designed to compare the effects of preemptive antifibrinolysis of single-dose and repeat-dose tranexamic acid (TXA) in in RA patients undergoing total knee arthroplasty (TKA). Methods/design: The study will be a double-blind randomized controlled trial with two parallel groups of RA patients. Group A will be given 100 ml normal saline twice daily starting from 3 days before the operation, Group B will be given TXA 1.5 g twice daily starting from 3 days before the operation. All patients will be given TXA 1.5 g 30 min before the operation. The primary outcomes will be evaluated with total blood loss and hidden blood loss. Other outcome measurements such as, fibrinolysis parameters, inflammatory factors, visual analogue scale for post- operative pain, analgesia usage, coagulation parameters, transfusion, the length of stay (LOS), total hospitalization costs, the incidence of thromboembolic events and other complications will be recorded and compared. Recruitment is scheduled to begin on 1 August 2020, and the study will continue until 31 May 2021. Discussion: In current literature there is a lack of evidence with regard to the efficacy of TXA in RA patients. -
Safety of Tirofiban for Patients with Acute Ischemic Stroke in Routine Clinical Practice
EXPERIMENTAL AND THERAPEUTIC MEDICINE 10: 169-174, 2015 Safety of tirofiban for patients with acute ischemic stroke in routine clinical practice YUAN-QUN ZHU1, YAN-JUN ZHANG2, HAI-LIN RUAN3, QING LIU2, QIN ZHAN2 and QIONG LI2 1Department of Neurology, Liuzhou Worker's Hospital, The Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, Guangxi 545005; 2Department of Geriatrics, People's Hospital of Zhengzhou, Zhengzhou, Henan 450003; 3Department of Emergency, Liuzhou Worker's Hospital, The Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, Guangxi 545005, P.R. China Received April 11, 2014; Accepted December 8, 2014 DOI: 10.3892/etm.2015.2495 Abstract. The aim of the present study was to investigate the Introduction safety of tirofiban alone and in combination with various treat- ments in acute ischemic stroke (AIS). A total of 120 patients Acute ischemic stroke (AIS) is a common cause of morbidity with AIS were included in the study, and these patients were and mortality worldwide. Thrombolysis with recombinant divided into three treatment groups: Group A (tirofiban alone, tissue plasminogen activator (rtPA) is the only proven beneficial n=68), group B (tirofiban plus thrombolytic therapy, n=26), therapy in AIS, and this is received by <2% of patients (1). The and group C (tirofiban as a ‘bridging therapy’, n=26). Risk inaccessibility of this treatment to the majority of patients is due factors, stroke severity, initial imaging, treatment regimens, to a number of factors: A lack of adequate transport facilities complications and long‑term outcomes were analyzed. In and infrastructure, including facilities for thrombolysis in most total, eight patients (6.7%) [six patients (23.1%) in group B centers; the high cost of tPA; and a lack of awareness among and two patients (7.7%) in group C] had hemorrhage during the public and doctors (2). -
Summary of the Product Characteristics
Tirofiban hydrochloride Hikma Pharma GmbH SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT <TIROFIBAN>® *50 micrograms/mL Solution for infusion <TIROFIBAN>® *250 micrograms/mL Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION <TIROFIBAN> Solution: 1 ml of solution for infusion contains 56 micrograms of tirofiban hydrochloride monohydrate which is equivalent to 50 micrograms Tirofiban. This medicinal product contains 31 mmol (or 715 mg) sodium per bag (250 ml). To be taken into consideration by patients on a controlled sodium diet. <TIROFIBAN> Concentrate: 1 ml of concentrate for solution for infusion contains 281 micrograms of tirofiban hydrochloride monohydrate which is equivalent to 250 micrograms Tirofiban. 50 ml of concentrate for solution for infusion contains 14,05 mg of tirofiban hydrochloride monohydrate which is equivalent to 12,5 mg Tirofiban. This medicinal product contains less than 1 mmol sodium (23 mg) per vial (50 ml), i.e. essentially ‘sodium- free’. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM <TIROFIBAN> Solution: Solution for Infusion (250 ml bag) A clear, colourless solution. <TIROFIBAN> Concentrate: Concentrate for solution for infusion. A clear, colourless concentrated solution. * in the following document the abbreviated terms detailed below are used. • <TIROFIBAN> means <TIROFIBAN> Solution for Infusion or <TIROFIBAN> Concentrate for Solution for Infusion. • <TIROFIBAN> Solution will be used when referring to <TIROFIBAN> Solution for Infusion -
The Role of Low-Molecular-Weight Heparin in the Management of Acute Coronary Syndromes Marc Cohen, MD, FACC Newark, New Jersey
CORE Metadata, citation and similar papers at core.ac.uk Provided by ElsevierJournal - ofPublisher the American Connector College of Cardiology Vol. 41, No. 4 Suppl S © 2003 by the American College of Cardiology Foundation ISSN 0735-1097/03/$30.00 Published by Elsevier Science Inc. doi:10.1016/S0735-1097(02)02901-7 The Role of Low-Molecular-Weight Heparin in the Management of Acute Coronary Syndromes Marc Cohen, MD, FACC Newark, New Jersey A substantial number of clinical studies have consistently demonstrated that low-molecular- weight heparin (LMWH) compounds are effective and safe alternative anticoagulants to unfractionated heparins (UFHs). They have been found to improve clinical outcomes in acute coronary syndromes and to provide a more predictable therapeutic response, longer and more stable anticoagulation, and a lower incidence of UFH-induced thrombocytopenia. Of the several LMWH agents that have been studied in large clinical trials, including enoxaparin, dalteparin, and nadroparin, not all have shown better efficacy than UFH. Enoxaparin is the only LMWH compound to have demonstrated sustained clinical and economic benefits in comparison with UFH in the management of unstable angina/ non–ST-segment elevation myocardial infarction (NSTEMI). Also, LMWH appears to be a reliable and effective antithrombotic treatment as adjunctive therapy in patients undergoing percutaneous coronary intervention. Clinical trials with enoxaparin indicate that LMWH is effective and safe in this indication, with or without the addition of a glycoprotein IIb/IIIa inhibitor. The efficacy demonstrated by enoxaparin in improving clinical outcomes in unstable angina/NSTEMI patients has led to investigations of its role in the management of ST-segment elevation myocardial infarction. -
Anticoagulant Effects of Statins and Their Clinical Implications
Review Article 1 Anticoagulant effects of statins and their clinical implications Anetta Undas1; Kathleen E. Brummel-Ziedins2; Kenneth G. Mann2 1Institute of Cardiology, Jagiellonian University School of Medicine, and John Paul II Hospital, Krakow, Poland; 2Department of Biochemistry, University of Vermont, Colchester, Vermont, USA Summary cleavage, factor V and factor XIII activation, as well as enhanced en- There is evidence indicating that statins (3-hydroxy-methylglutaryl dothelial thrombomodulin expression, resulting in increased protein C coenzyme A reductase inhibitors) may produce several cholesterol-inde- activation and factor Va inactivation. Observational studies and one ran- pendent antithrombotic effects. In this review, we provide an update on domized trial have shown reduced VTE risk in subjects receiving statins, the current understanding of the interactions between statins and blood although their findings still generate much controversy and suggest that coagulation and their potential relevance to the prevention of venous the most potent statin rosuvastatin exerts the largest effect. thromboembolism (VTE). Anticoagulant properties of statins reported in experimental and clinical studies involve decreased tissue factor ex- Keywords pression resulting in reduced thrombin generation and attenuation of Blood coagulation, statins, tissue factor, thrombin, venous throm- pro-coagulant reactions catalysed by thrombin, such as fibrinogen boembolism Correspondence to: Received: August 30, 2013 Anetta Undas, MD, PhD Accepted after major revision: October 15, 2013 Institute of Cardiology, Jagiellonian University School of Medicine Prepublished online: November 28, 2013 80 Pradnicka St., 31–202 Krakow, Poland doi:10.1160/TH13-08-0720 Tel.: +48 12 6143004, Fax: +48 12 4233900 Thromb Haemost 2014; 111: ■■■ E-mail: [email protected] Introduction Most of these additional statin-mediated actions reported are independent of blood cholesterol reduction. -
GP Iib/Iiia Adult Cardiology Treatment Dosing and Monitoring Guidelines
GP IIb/IIIa Inhibitor Adult Cardiology Treatment Dosing and Monitoring Guidelines During times of eptifibatide shortage, the following guidance is available for tirofiban usei Eptifibatide (Integrilin®) Tirofiban (Aggrastat®) Dosing Loading dose: 180 mcg/kg IV bolus (max: 22.6 mg) Loading dose: 25 mcg/kg IV over 5 minutes ii ACS Maintenance infusion: 2 mcg/kg/minute (max: 15 mg/hr) up to 72 hours Maintenance infusion: 0.15 mcg/kg/minute continued for up to 18 (until discharge or CABG surgery) hours st 1 Loading dose: 180 mcg/kg IV bolus (max: 22.6 mg) Loading dose: 25 mcg/kg IV over 5 minutes ii PCI Maintenance infusion: 2 mcg/kg/minute (max: 7.5 mg/hr) continued for Maintenance infusion: 0.15 mcg/kg/minute continued for up to 18 up to 18 to 24 hours hours 2nd loading dose: 180 mcg/kg IV bolus (max: 22.6 mg) should be administered 10 minutes after the first bolus Dose Adjustment For CrCl ≤ 50 mL/minute: For CrCl ≤ 60 mL/minute: 1st loading dose: 180 mcg/kg IV bolus (max: 22.6 mg) Loading dose: 25 mcg/kg IV over 5 minutes Maintenance infusion: 2 mcg/kg/minute (max 7.5 mg/hr) Maintenance infusion: 0.075 mcg/kg/minute continued for up to 18 2nd loading dose (if PCI): 180 mcg/kg IV bolus (max: 22.6 mg) should be hours administered 10 minutes after the first bolus For end-stage renal disease: CONTRAINDICATED Contraindications − Severe hypersensitivity reaction to eptifibatide − Severe hypersensitivity reaction to tirofiban − History of bleeding diathesis or evidence of active abnormal bleeding − A history of thrombocytopenia following prior -
Summary of the Product Characteristics
Tirofiban hydrochloride Welding GmbH & Co.KG 1.3 Product Information SUMMARY OF THE PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT <TIROFIBAN>® *50 micrograms/mL Solution for infusion <TIROFIBAN>® *250 micrograms/mL Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION <TIROFIBAN> Solution: 1 ml of solution for infusion contains 56 micrograms of Tirofiban hydrochloride monohydrate which is equivalent to 50 micrograms Tirofiban. This medicinal product contains 31 mmol (or 715 mg) sodium per bag (250 ml). To be taken into consideration by patients on a controlled sodium diet. <TIROFIBAN> Concentrate: 1 ml of concentrate for solution for infusion contains 281 micrograms of Tirofiban hydrochloride monohydrate which is equivalent to 250 micrograms Tirofiban. 50 ml of concentrate for solution for infusion contains 70.2514,05 mg of Tirofiban hydrochloride monohydrate which is equivalent to 62.512,5 mg Tirofiban. This medicinal product contains less than 1 mmol sodium (23 mg) per vial (50 ml), i.e. essentially ‘sodium- free’. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM <TIROFIBAN> Solution: Solution for Infusion (250 ml bag) A clear, colourless solution. <TIROFIBAN> Concentrate: Concentrate for solution for infusion. A clear, colourless concentrated solution. * in the following document the abbreviated terms detailed below are used. • <TIROFIBAN> means <TIROFIBAN> Solution for Infusion or <TIROFIBAN> Concentrate for Solution for Infusion. • <TIROFIBAN> Solution will be used when referring to <TIROFIBAN> -
Statistical Analysis Plan – Part 1
NCT03251482 Janssen Research & Development Statistical Analysis Plan – Part 1 A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design, Dose Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery Protocol 64179375THR2001; Phase 2 JNJ-64179375 Status: Approved Date: 18 October 2017 Prepared by: Janssen Research & Development, LLC Document No.: EDMS-ERI-148215770 Compliance: The study described in this report was performed according to the principles of Good Clinical Practice (GCP). Confidentiality Statement The information in this document contains trade secrets and commercial information that are privileged or confidential and may not be disclosed unless such disclosure is required by applicable law or regulations. In any event, persons to whom the information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed by them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as privileged or confidential. 1 Approved, Date: 18 October 2017 JNJ-64179375 NCT03251482 Statistical Analysis Plan - Part 1 64179375THR2001 TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................................... 2 LIST OF IN-TEXT TABLES AND FIGURES ............................................................................................... -
Antiplatelets, Anticoagulants and Bleeding Risk and Ppis
GP INFOSHEET – ANTITHROMBOTICS AND BLEEDING RISK Author(s): Dr. Stuart Rison; Dr. John Robson; Version: 1.6; Last updated 28/11/2019 ANTIPLATELETS, ANTICOAGULANTS AND BLEEDING RISK – WHICH AGENTS AND FOR HOW LONG?; WHY USE PPIs? KEY RECOMMENDATION Patients taking anticoagulants or antiplatelet medicines at high bleed risk should be considered for a Proton Pump Inhibitor (PPI). PPIs reduce bleeding risk by 70% or more. Patients age 65 years or more on anticoagulants or antiplatelet agents are at increased risk because of their age and bleeding risk continues to rise exponentially at older ages. PPIs are recommended in patients on anticoagulants or antiplatelet agents: o At any age with previous GI bleeding o Age 75 years or older o 65 years or older with additional risk factors (see box below) o Interacting medication Dual antiplatelet therapy (DAPT) for cardiac conditions - typically aspirin + clopidogrel - is rarely justified for more than 1 year. Review use for more than one 1 year and in conjunction with the cardiologist consider whether this can revert to a single agent. Dual-pathway therapy for atrial fibrillation - both an anticoagulant and one or more antiplatelet agents- is also rarely justified for longer than 1 year. Consider anticoagulant alone with appropriate specialist advice. ADDITIONAL GI-BLEED RISK FACTORS Anaemia Hb <11g/L Impaired renal function (eGFR<30) Upper GI inflammation (and of course previous GI bleeding) Liver disease Interacting medicines (NSAIDs, SSRI/SNRIs, bisphosphonates, lithium, spironolactone, phenytoin, carbamazepine) WHAT DO WE MEAN BY ANTITHROMBOTICS? Antithrombotics reduce blood clot formation1. There are two main categories: 1. Antiplatelet agent – inhibit platelet aggregation e.g. -
Current Status of Antifibrinolytics in Cardiopulmonary Bypass and Elective Deep Hypothermic Circulatory Arrest Jeffrey A
Anesthesiology Clin N Am 21 (2003) 527–551 Current status of antifibrinolytics in cardiopulmonary bypass and elective deep hypothermic circulatory arrest Jeffrey A. Green, MD*, Bruce D. Spiess, MD Department of Anesthesiology, Virginia Commonwealth University, Medical College of Virginia Campus, 1200 East Broad Street, PO Box 980695, Richmond, VA 23209 USA Bleeding after cardiopulmonary bypass Cardiopulmonary bypass (CPB) alters the hemostatic balance and predisposes cardiac surgery patients to an increased risk of microvascular bleeding. Bleeding and the need for transfusion are among the most common complications of cardiac surgery. In fact, until recently, blood transfusions seemed to be required for about 50% of all cardiac surgery patients [1]. Currently, CPB accounts for 10% to 20% of the transfusions performed in the United States [2,3]. Transfusion, however, exposes patients to added risks such as infectious disease transmission [4], transfusion reactions [5], graft-versus-host disease [6], transfusion-induced lung injury [7], and decreased resistance to postoperative infection [8,9]. Transfusion increases the risk of infection by 35% to 300% and increases the risk of pneumonia in coronary artery bypass (CABG) patients by 5% per unit transfused [10]. The primary purported benefit of transfusion, increased oxygen carrying capacity, has not been definitively proven. Excessive postoperative bleeding may necessitate surgical reexploration, increasing morbidity, and mortality. Postoperatively, the risk of excessive bleeding is 11% [11], and 5% to 7% of patients lose more than 2 L of blood in the first 24 hours after CPB [12]. Reexploration for hemorrhage is required in 3.6% to 4.2% of patients [13], and mortality rates range from 10% to 22% [14]. -
Proposal for Inclusion of Tranexamic Acid in the Who List of Essential Medicines
PROPOSAL FOR INCLUSION OF TRANEXAMIC ACID IN THE WHO LIST OF ESSENTIAL MEDICINES General items 1. Summary statement of the proposal for inclusion, change or deletion. Tranexamic acid (TXA) is included in the EML as a medicine affecting the blood/medicines affecting coagulation. This proposal is to request the inclusion of TXA in the World Health Organization (WHO) Model Lists of Essential Medicines (EML) for treatment of postpartum haemorrhage (PPH) as an additional indication in the section covering maternal health medicines. TXA should be administered to the woman, as part of the standard PPH treatment package, as soon as possible after the onset of bleeding and within 3 hours of birth.1 TXA should be administered at a fixed dose of 1 g in 10 ml (100 mg/ml) IV at 1 ml per minute, with a second dose of 1 g IV if bleeding continues after 30 minutes. TXA is a competitive inhibitor of plasminogen activation and reduces bleeding by inhibiting the breakdown of fibrinogen and fibrin clots. In 2017, a large randomized controlled trial showed that early use of IV TXA reduces death due to bleeding in women with PPH, regardless of the cause, and with no adverse maternal effects.2 Based on this evidence, on the Cochrane systematic review on the efficacy of TXA for PPH, and on an individual meta-analysis of 40,138 bleeding patients, WHO updated its PPH treatment recommendations to include use of TXA for treatment of PPH in 2017.1,3 2. Relevant WHO technical department and focal point Department of Reproductive Health and Research (RHR). -
Urticaria and Angioedema
Urticaria and Angioedema This guideline, developed by Robbie Pesek, MD and Allison Burbank, MD, in collaboration with the ANGELS team, on July 23, 2013, is a significantly revised version of the guideline originally developed by Jeremy Bufford, MD. Last reviewed by Robbie Pesek, MD September 14, 2016. Key Points Urticaria and angioedema are common problems and can be caused by both allergic and non- allergic mechanisms. Prompt diagnosis of hereditary angioedema (HAE) is important to prevent morbidity and mortality. Several new therapeutic options are now available. Patients with urticaria and/or angioedema should be referred to an allergist/immunologist for symptoms that are difficult to control, suspicion of HAE, or to rule out suspected allergic triggers. Definition, Assessment, and Diagnosis Definitions Urticaria is a superficial skin reaction consisting of erythematous, raised, blanching, well- circumscribed or confluent pruritic, edematous wheals, often with reflex erythema.1-3 Urticarial lesions are typically pruritic, and wax/wane with resolution of individual lesions within 24 hours. Angioedema is localized swelling of deep dermal, subcutaneous, or submucosal tissue resulting from similar vascular changes that contribute to urticaria.1,2 Angioedema may be pruritic and/or painful and can last for 2-3 days depending on etiology.3 1 Urticaria alone occurs in 50% of patients and is associated with angioedema in 40% of patients. Isolated angioedema occurs in 10% of patients.1,2 Hereditary angioedema (HAE) is a disorder involving defects in complement, coagulation, kinin, and fibrinolytic pathways that results in recurrent episodes of angioedema without urticaria, usually affecting the skin, upper airway, and gastrointestinal tract.4 In children, acute urticaria is more common than chronic forms.