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Lessons from ximelagatran: issues for future studies evaluating new oral direct thrombin inhibitors for venous thromboembolism prophylaxis in orthopedic surgery

The authors concluded that the risk-benefit profile of ximelagatran used as thromboprophylaxis in total hip and knee replacement surgery depended on the surgery type, initial timing of administration and probably dose. This was generally a well-conducted review, but given the limited number and heterogeneous nature of the studies, the conclusion should be treated with caution.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2009

Direct thrombin inhibitors in acute coronary syndromes: effect in patients undergoing early percutaneous coronary intervention

AIMS: We evaluated the effect of direct thrombin inhibitors (DTIs) in patients undergoing early percutaneous coronary intervention (PCI), using the DTI Trialists' Collaboration database of 35,970 patients from 11 randomized trials of DTIs vs. heparin.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2005

Meta-analysis of randomized controlled trials on risk of myocardial infarction from the use of oral direct thrombin inhibitors

Dabigatran has been associated with greater risk of myocardial infarction (MI) than warfarin. It is unknown whether the increased risk is unique to dabigatran, an adverse effect shared by other oral direct thrombin inhibitors (DTIs), or the result of a protective effect of warfarin against MI. To address these questions, we systematically searched MEDLINE and performed a meta-analysis on randomized trials that compared oral DTIs with warfarin for any indication with end point of MIs after randomization. We furthermore performed a secondary meta-analysis on atrial fibrillation stroke prevention trials with alternative anticoagulants compared with warfarin with end point of MIs after randomization. A total of 11 trials (39,357 patients) that compared warfarin to DTIs (dabigatran, ximelagatran, and AZD0837) were identified. In these trials, patients treated with oral DTIs were more likely to experience an MI than their counterparts treated with warfarin (285 of 23,333 vs 133 of 16,024, odds ratio 1.35, 95% confidence interval 1.10 to 1.66, p = 0.005). For secondary analysis, 8 studies (69,615 patients) were identified that compared warfarin with alternative anticoagulant including factor Xa inhibitors, DTIs, aspirin, and clopidogrel. There was no significant advantage in the rate of MIs with the use of warfarin versus comparators (odds ratio 1.06, 95% confidence interval 0.85 to 1.34, p = 0.59). In conclusion, our data suggest that oral DTIs were associated with increased risk of MI. This increased risk appears to be a class effect of these agents, not a specific phenomenon unique to dabigatran or protective effect of warfarin. These findings support the need for enhanced postmarket surveillance of oral DTIs and other novel agents.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

Direct thrombin inhibitors compared with vitamin K antagonists in people with atrial fibrillation for preventing stroke

Question: We wanted to compare the effectiveness and safety of direct thrombin inhibitors (DTIs) with vitamin K antagonists in people with atrial fibrillation (AF) to prevent stroke.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Venous Thromboembolism Prophylaxis in Orthopedic Surgery [Internet]

This is an evidence report prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center (EPC) examining the comparative efficacy and safety of prophylaxis for venous thromboembolism in major orthopedic surgery (total hip replacement [THR], total knee replacement [TKR], and hip fracture surgery [HFS]) and other nonmajor orthopedic surgeries (knee arthroscopy, injuries distal to the hip requiring surgery, and elective spine surgery).

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US).

Version: March 2012
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Pharmacologic and Mechanical Prophylaxis of Venous Thromboembolism Among Special Populations [Internet]

Venous thromboembolism (VTE) is a prevalent and avoidable complication of hospitalization. Patients hospitalized with trauma, traumatic brain injury, burns, or liver disease; patients on antiplatelet therapy; obese or underweight patients; those having obesity surgery; or with acute or chronic renal failure have unequal risks for bleeding and thrombosis and may benefit differently from prophylactic therapy medication.

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US).

Version: May 2013
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Safe and Effective Anticoagulation in the Outpatient Setting: A Systematic Review of the Evidence [Internet]

The primary objectives of this systematic review were to: 1. Determine whether specialized anticoagulation clinics (ACC) are more effective and safer than care in non-specialized clinics (e.g., primary care clinics, physician offices) for management of long- term anticoagulation in adults; 2. Determine whether patient self testing (PST), either alone or in combination with patient self management (PSM), is more effective and safer than standard care; and 3. Identify the risk factors for serious bleeding in patients on chronic anticoagulant therapy.

Evidence-based Synthesis Program - Department of Veterans Affairs (US).

Version: February 2011
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New Oral Anticoagulants for the Prevention of Thromboembolic Events in Patients with Atrial Fibrillation [Internet]

Atrial fibrillation (AF), the most common cardiac rhythm abnormality, is associated with substantial morbidity. AF-related mortality is mainly attributable to complications of stroke. Stroke risk can be quantified using a validated tool such as the CHADS2 score. Warfarin, a vitamin K antagonist, is the standard of care for patients with AF and has demonstrated efficacy in the prevention of stroke. Warfarin has a narrow therapeutic window, produces varied responses among patients, and interacts with some types of food and other drugs, all of which necessitates routine laboratory monitoring.

CADTH Therapeutic Review - Canadian Agency for Drugs and Technologies in Health.

Version: 2012
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Comparative Effectiveness of Newer Oral Anticoagulants and Standard Anticoagulant Regimens for Thromboprophylaxis in Patients Undergoing Total Hip or Knee Replacement [Internet]

Venous thromboembolic (VTE) events are important causes of morbidity in elective total hip replacement (THR) and total knee replacement (TKR) procedures. Current guidelines recommend thromboprophylaxis in patients undergoing THR or TKR, although the American Academy of Orthopaedic Surgeons (AAOS) guidelines suggest individual assessment of patients when choosing the specific thromboprophylaxis strategy. Low molecular weight heparin (LMWH) and adjusted-dose warfarin are the most commonly used anticoagulants for thromboprophylaxis in the United States, but a number of other treatment options are available, including unfractionated heparin, aspirin, mechanical devices, and newer oral anticoagulants.

Evidence-based Synthesis Program - Department of Veterans Affairs.

Version: December 2012
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Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care [Internet]

This report evaluates the level of evidence currently available to support the effectiveness and safety of using recombinant activated coagulation factor VII (rFVIIa) for clinical indications not approved by the U. S. Food and Drug Administration (FDA). rFVIIa is approved for a variety of uses in hemophilia patients who have developed antibody inhibitors that compromise the use of standard factor replacement. Use of this costly biologic product has expanded beyond these hemophilia-related indications to encompass a range of off-label uses, most of which are in-hospital uses. These uses differ substantially from the drug’s FDA approved label. The purpose of this report is two-fold: (1) To document the full range of clinical indications for which rFVIIa is being used and the types of studies available to evaluate these uses and (2) To provide a comparative effectiveness review of rFVIIa vs. usual care for several in-hospital clinical indications: intracranial hemorrhage, massive bleeding secondary to trauma, and the selected surgical procedures of cardiac surgery, liver transplantation, and prostatectomy.

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US).

Version: May 2010
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Enabling Medication Management Through Health Information Technology

The objective of the report was to review the evidence on the impact of health information technology (IT) on all phases of the medication management process (prescribing and ordering, order communication, dispensing, administration and monitoring as well as education and reconciliation), to identify the gaps in the literature and to make recommendations for future research.

Evidence Reports/Technology Assessments - Agency for Healthcare Research and Quality (US).

Version: April 2011
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Heavy Menstrual Bleeding

Heavy menstrual bleeding (HMB) has an adverse effect on the quality of life of many women. It is not a problem associated with significant mortality. Many women seek help from their general practitioners and it is a common reason for referral into secondary care.

NICE Clinical Guidelines - National Collaborating Centre for Women's and Children's Health (UK).

Version: January 2007
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Comparative Effectiveness of Warfarin and Newer Oral Anticoagulants for the Long-Term Prevention and Treatment of Arterial and Venous Thromboembolism [Internet]

The Veterans Health Administration (VHA) System serves a largely older, male population with a high prevalence of chronic atrial fibrillation (AF) and venous thromboembolism (VTE). Many veterans with chronic AF have risk profiles for stroke that, according to current clinical guidelines, place them in a risk group where chronic anticoagulation is recommended. Adjusted-dose warfarin has been the preferred approach to chronic anticoagulation in the VHA, and in many VHA settings, specialized therapeutic drug-monitoring services provide high-quality warfarin treatment. However, the advent of newer anticoagulants with the promise of simplified long-term anticoagulation requires reconsideration of current treatment practices. The purpose of this systematic review was to study the comparative effectiveness of warfarin and the newer oral anticoagulants used for the long-term prevention and treatment of arterial and venous thromboembolism. An evaluation of newer oral anticoagulants for VTE prophylaxis in the perioperative period will be the subject of a later report.

Evidence-Based Synthesis Program - Department of Veterans Affairs.

Version: April 2012
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Outcomes of Genetic Testing in Adults with a History of Venous Thromboembolism

To address whether Factor V Leiden (FVL) testing alone, or in combination with prothrombin G20210A testing, leads to improved clinical outcomes in adults with a personal history of venous thromboembolism (VTE) or to improved clinical outcomes in adult family members of mutation-positive individuals.

Evidence Reports/Technology Assessments - Agency for Healthcare Research and Quality (US).

Version: June 2009
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Comparative Effectiveness of Radiofrequency Catheter Ablation for Atrial Fibrillation [Internet]

The Agency for Healthcare Research and Quality (AHRQ) commissioned this report to review the evidence for the clinical effects and safety of radiofrequency catheter ablation (RFA) for the management of atrial fibrillation (AF). Over the past decade, RFA has rapidly evolved as a tool for managing AF in select patients. This rapid evolution has been driven by an enhanced understanding of the triggers and etiology of AF and the development of advanced catheter and imaging technologies.

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US).

Version: July 2009
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The Management of Inadvertent Perioperative Hypothermia in Adults [Internet]

Inadvertent perioperative hypothermia is a common but preventable complication of perioperative procedures, which is associated with poor outcomes for patients. Inadvertent perioperative hypothermia should be distinguished from the deliberate induction of hypothermia for medical reasons, which is not covered by this guideline.

NICE Clinical Guidelines - National Collaborating Centre for Nursing and Supportive Care (UK).

Version: April 2008
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Treatment of heparin-induced thrombocytopenia: a critical review

This review assessed the effects of replacing heparin with new anticoagulants in patients with heparin-induced thrombocytopenia. The authors' conclusions appear to be that lepirudin and argatroban are effective anticoagulants, but the evidence was limited and further research is required. The authors correctly acknowledged the limitations of evidence from the included observational studies.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2004

Treatments for swelling of an artery in the groin following vascular procedures

People with heart disease and diseased leg arteries often undergo investigations and treatments that involve placing a needle into the main artery in the groin (endovascular procedures, for example diagnostic arteriogram, angioplasty, cardiac catheterization). One possible complication is the formation of a large swelling in the artery (a pseudoaneurysm) in the groin. This happens when the hole that the needle makes in the wall of the artery does not seal properly afterwards and blood collects, causing pain, swelling and bruising. Small pseudoaneurysms may clot spontaneously or surgery may be required. Less invasive treatment is now possible to stop the blood flow into the swelling. This involves sedation or analgesia to allow pressure to be placed over the puncture in the artery using a special mechanical device or a probe guided by ultrasound. Another option is injection of a clotting agent (thrombin) through the skin into the swelling.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Topical haemostatic agents for skin wounds: a systematic review

This review evaluated the effectiveness of haemostatic agents in patients with donor site split-skin graft wounds. The authors concluded that epinephrine and fibrin sealant appeared superior agents for stopping bleeding in patients with skin wounds from burns. Limited data means that the results warrant cautious interpretation; this reflects the emphasis of the authors' conclusion.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2011

New types of anticoagulants to prevent deep vein thrombosis and pulmonary embolism following total hip or knee replacement surgery

Venous thromboembolism is the presence of a blood clot that blocks a blood vessel within the venous system; it includes deep vein thrombosis (DVT) and pulmonary embolism (PE) which can be fatal. Venous thromboembolism occurs in 44% to 90% of those patients who undergo total hip or knee replacement and who do not receive anticoagulants (blood thinning drugs).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2011

Medical Encyclopedia

  • Congenital afibrinogenemia
    Congenital afibrinogenemia is a rare, inherited blood disorder in which the blood does not clot normally. It occurs when there is a  protein called fibrinogen is totally lacking. This protein is needed for the blood to clot.
  • Factor X deficiency
    Factor X (ten) deficiency is a disorder caused by too little of a protein called factor X in the blood. It leads to problems with normal blood clotting (coagulation).
  • Pulmonary Embolism
    A pulmonary embolism is a sudden blockage in a lung artery.
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