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Prothrombin complex concentrate (PCC) is a drug that contains a source of proteins involved in the human blood clotting process. Patients medicated with vitamin K antagonists (blood thinning drug) have low blood levels of these important blood clotting proteins. Therefore these patients will be at increased risk of spontaneous and traumatic bleeding events. Also, when these patients experience a bleeding event, this will lead to progressive loss of these important blood clotting proteins. This process causes a vicious circle, thereby increasing risks of illness and death.

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

Version: July 7, 2015

This guideline contains recommendations about general principles of blood transfusion, and applies to a range of conditions and different settings. It does not include recommendations relating to specific conditions and provides guidance on:

NICE Guideline - National Clinical Guideline Centre (UK).

Version: November 2015

The use of prothrombin complex concentrates (PCCs) and fibrinogen concentrates (FIBCs) to achieve hemostasis in the perioperative setting as alternatives to allogeneic blood products remains controversial. To examine the efficacy and safety of PCCs and FIBCs, we conducted a systematic review-in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement-to compare the use of these transfusion alternatives in bleeding surgical patients. We performed a literature search of English articles published between July 1997 and July 2012 in MEDLINE via PubMed, The Cochrane Library, and CINAHL. Five randomized trials and 15 nonrandomized studies with a comparator group were included in the final review. Studies were sorted into 1 of the following 3 clinical settings: cardiac surgery, non-cardiac surgery, and reversal of warfarin anticoagulation. Risk of bias was assessed using the Cochrane risk of bias tool. With the exception of 2 randomized controlled trials, the existing body of literature on the use of PCCs and FIBCs in the perioperative setting was assessed to have a high degree of methodological bias. Overall, prospective studies in the cardiac surgery grouping suggested that patients receiving FIBC and/or PCCs required less allogeneic blood transfusion and had less chest tube drainage. In studies of warfarin reversal, PCCs more rapidly corrected the International Normalized Ratio compared to plasma; however, in the setting of intracranial hemorrhage, functional outcomes were poor regardless of the reversal strategy. With regards to safety outcomes, reporting was not uniform and raises concerns of underreporting. Adequately powered, methodologically sound trials would be required for more definitive conclusions to be drawn about the efficacy of PCCs and FIBC over conventional blood components for the treatment of perioperative coagulopathy in bleeding patients.

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

Version: 2013

Prothrombin complex concentrates (PCCs) are recommended as the treatment of choice in warfarin-related coagulopathy. However, the risk of thromboembolic complications associated with their use is not well defined. We performed a meta-analysis to estimate the rate of thromboembolic complications in patients receiving vitamin K antagonists (VKAs) treated with PCCs for bleeding or before urgent surgery. Medline and Embase databases were searched. Two reviewers performed study selection and extracted data independently. Studies providing data on incidence of thromboembolic complications in VKA-treated patients were eligible for the study. Weighted mean proportion of the rate of thromboembolic complications and the mortality rate were calculated. Twenty-seven studies (1,032 patients) were included. Seven studies used 3-factor, and 20 4-factor PCCs. Twelve patients had a thromboembolic complication (weighted mean 1.4%; 95% CI 0.8-2.1), of which two were fatal. The incidence of thromboembolic events was 1.8% (95% CI 1.0-3.0) in patients treated with 4-factor PCCs, and 0.7% (95% CI 0.0-2.4) in patients treated with 3-factor PCCs. Total mortality rate was 10.6% (95% CI 5.9-16.6). In conclusion, our results suggest there is a low but quantifiable risk of thromboembolism in VKA-treated patients receiving PCCs for anticoagulation reversal. These findings should be confirmed in randomised, controlled trials.

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

Version: 2011

INTRODUCTION: Prothrombin complex concentrates are used for rapid reversal of vitamin K antagonists in patients with bleeding or those requiring surgery or invasive procedures. Current guidelines suggest 4-factor products are preferred over 3-factor prothrombin complex concentrates.

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

Version: 2012

Two of the five guidelines in the NICE Trauma Suite relate to fractures. These are titled non-complex and complex fractures. In broad terms the non-complex fractures are those likely to be treated at the receiving hospital, whereas the complex fractures require transfer or the consideration of transfer of the injured person to a specialist centre.

NICE Guideline - National Clinical Guideline Centre (UK).

Version: February 2016

Two of the five guidelines in the NICE trauma suite relate to fractures. These are titled non-complex and complex fractures. In broad terms, non-complex fractures are those likely to be treated at the receiving hospital, whereas complex fractures require transfer or the consideration of transfer of the injured person to a specialist.

NICE Guideline - National Clinical Guideline Centre (UK).

Version: February 2016

The scope of this guideline is the assessment, imaging and early management of spinal injury and does not address rehabilitation. It is important to recognise that early management is intrinsically connected to rehabilitation and some later complications may be avoided with changes in early care. Early and ongoing collaborative multidisciplinary care across a trauma network is vital in ensuring that the patient with a spinal injury receives the best possible care.

NICE Guideline - National Clinical Guideline Centre (UK).

Version: February 2016

This guideline provides guidance on the assessment and management of major trauma, including resuscitation following major blood loss associated with trauma. For the purposes of this guideline, major trauma is defined as an injury or a combination of injuries that are life-threatening and could be life changing because it may result in long-term disability. This guideline covers both the pre-hospital and immediate hospital care of major trauma patients but does not include any management after definitive lifesaving intervention. It has been developed for health practitioners and professionals, patients and carers and commissioners of health services.

NICE Guideline - National Clinical Guideline Centre (UK).

Version: February 2016

A trauma service provides care for people who have sustained physical injuries. These injuries are often the result of an accident but can be sustained in other circumstances. Injuries range from minor to serious life-threatening trauma. The scope of this guidance is the delivery of services for people with major trauma in the initial phase of care, exploring areas of uncertainty and variation.

NICE Guideline - National Clinical Guideline Centre (UK).

Version: February 2016

Infusion of bypassing agents, such as recombinant activated FVII (rFVIIa) and plasma‐derived activated prothrombin complex concentrate (APCC), are suggested as alternative therapies to factor VIII (haemophilia A) or IX (haemophilia B) for individuals who no longer respond to these treatments because they develop inhibitory antibodies. The ultimate goal of treatment is to preserve the individual's joints, otherwise destroyed by recurrent bleeds. We therefore evaluated the effectiveness and safety of bypassing agents when used to prevent, as compared to treat, bleeds. We also compared different doses of bypassing agents in men with hemophilia A or B with inhibitors as a preventative (prophylactic) therapy.

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

Version: September 25, 2017

Alcohol is the most widely used psychotropic drug in the industrialised world; it has been used for thousands of years as a social lubricant and anxiolytic. In the UK, it is estimated that 24% of adult men and 13% of adult women drink in a hazardous or harmful way. Levels of hazardous and harmful drinking are lowest in the central and eastern regions of England (21–24% of men and 10–14% of women). They are highest in the north (26–28% of men, 16–18% of women). Hazardous and harmful drinking are commonly encountered amongst hospital attendees; 12% of emergency department attendances are directly related to alcohol whilst 20% of patients admitted to hospital for illnesses unrelated to alcohol are drinking at potentially hazardous levels. Continued hazardous and harmful drinking can result in dependence and tolerance with the consequence that an abrupt reduction in intake might result in development of a withdrawal syndrome. In addition, persistent drinking at hazardous and harmful levels can also result in damage to almost every organ or system of the body. Alcohol-attributable conditions include liver damage, pancreatitis and the Wernicke’s encephalopathy. Key areas in the investigation and management of these conditions are covered in this guideline.

NICE Clinical Guidelines - National Clinical Guideline Centre (UK).

Version: 2010

The purpose of this report is to review the clinical effectiveness and cost of strategies to identify over-anticoagulation states and strategies to treat bleeding associated with the use of dabigatran, rivaroxaban, and apixaban, with the broader aim to help inform future listing recommendations and decisions, as well as clinical practice.

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

Version: April 2012

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

The study found that viscoelastic testing may be effective in reducing the numbers of cardiac surgery patients receiving red blood cell transfusion, platelet transfusion and fresh frozen plasma transfusion, compared with a management strategy based on standard laboratory tests.

Health Technology Assessment - NIHR Journals Library.

Version: July 2015

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

The objectives of this health technology assessment were to evaluate the accuracy, and clinical and cost-effectiveness of point-of-care (POC) international normalized ratio (INR) devices compared with standard lab testing, and between POC INR devices. A systematic review was performed to evaluate the accuracy and clinical effectiveness of POC INR. We also performed a primary economic analysis of the cost-effectiveness of POC INR from a Canadian perspective, as well as a review of the health services impact in Canada.

CADTH Optimal Use Report - Canadian Agency for Drugs and Technologies in Health.

Version: July 2014

Venous thromboembolism (VTE) is a condition in which a blood clot (a thrombus) forms in a vein and then dislodges to travel in the blood (an embolus). A venous thrombus most commonly occurs in the deep veins of the legs or pelvis; this is then called a deep vein thrombosis (DVT). Blood flow through the affected vein can be limited by the clot, and it can cause swelling and pain in the leg. If it dislodges and travels to the lungs, to the pulmonary arteries, it is called a pulmonary embolism (PE), which in some cases may be fatal. VTE as a term includes both DVT and PE. Major risk factors for VTE include a prior history of DVT, age over 60 years, surgery, obesity, prolonged travel, acute medical illness, cancer, immobility, thrombophilia (an abnormal tendency for the blood to clot) and pregnancy.

NICE Clinical Guidelines - National Clinical Guideline Centre (UK).

Version: June 2012

Study found that the post D-dimer model performed strongly and could be useful to predict individuals’ risk of recurrence of venous thromboembolism at any time up to 2–3 years, thereby aiding patient counselling and treatment decisions.

Health Technology Assessment - NIHR Journals Library.

Version: February 2016

This clinical guideline concerns the management of hypertensive disorders in pregnancy and their complications from preconception to the postnatal period. For the purpose of this guideline, ‘pregnancy’ includes the antenatal, intrapartum and postpartum (6 weeks after birth) periods. The guideline has been developed with the aim of providing guidance in the following areas: information and advice for women who have chronic hypertension and are pregnant or planning to become pregnant; information and advice for women who are pregnant and at increased risk of developing hypertensive disorders of pregnancy; management of pregnancy with chronic hypertension; management of pregnancy in women with gestational hypertension; management of pregnancy for women with pre-eclampsia before admission to critical care level 2 setting; management of pre-eclampsia and its complications in a critical care setting; information, advice and support for women and healthcare professionals after discharge to primary care following a pregnancy complicated by hypertension; care of the fetus during pregnancy complicated by a hypertensive disorder.

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

Version: August 2010

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