
Observatory of Invasive Procedures and Bleeding in Patients Treated With New Oral Anticoagulants...
Venous ThromboembolismAtrial FibrillationThe arrival on the market of direct oral factor Xa and factor IIa inhibitors (dabigatran (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) and others soon to come) raises novel questions among clinicians confronted with the emergency management of patients treated with these new drugs. It is likely that these new oral anticoagulants (NOACs) will eventually win a significant market share in the indications secondary prevention of venous thromboembolism and prevention of cardioembolic events in patients with nonvalvular atrial fibrillation, due to their net clinical benefit and their practicality of use compared with vitamin K antagonists (VKAs). However, despite the fact that NOACs reduce the incidence of intracranial bleeding by about half compared with VKAs, the risk remains significant; furthermore, in clinical trials, these drugs had little or no effect on reducing the incidence of major extracranial bleeding. In everyday practice, where the indication could be expanded to unselected populations and due to a potential for misuse, it is likely that the incidence of bleeding complications will be higher than that reported in clinical trials. Indeed, the numerous alerts emanating from regulatory agencies in various countries (US, Australia, etc.) bear witness to this, and should serve as a reminder that these anticoagulants have a real potential for bleeding complications and, in the absence of an antidote, there is no validated management strategy. Furthermore, as these drugs can be prescribed for months or years, patients may eventually be exposed to situations at high hemorrhagic risk, such as emergency surgery or invasive procedures, trauma, etc. Analysis of data from the trial : dabigatran versus warfarin in patients with atrial fibrillation (RE-LY) showed that during the two years of follow-up, approximately 25% of the patients underwent an invasive procedure, ranging from pacemaker insertion to major surgery. Thus, a large proportion of patients treated with NOACs are concerned by this issue. In anticipation of a gradually increasing influx of patients in a critical situation (active bleeding or need to rapidly secure hemostasis before an invasive procedure), it is urgent to define the conduct to adopt based on the experience gained from the earliest cases. This is the objective of the French-speaking GIHP-NACO observatory set up by the GIHP (French Working Group on Perioperative Hemostasis). For the moment, then, the management recommendations derive from expert opinions based on pharmacokinetic data and on the partial correction of NOAC-induced hypocoagulability by various nonspecific procoagulants (non-activated or activated prothrombin complex concentrates, recombinant factor VIIa). These procoagulants are currently used in an empirical manner to control bleeding, with as many successes as failures reported in the literature, and their benefit-risk ratio in these patients is therefore uncertain.

Pro-coagulant Markers and Anticoagulant Failure in Cancer Patients at Risk for Recurrence of Venous...
Venous ThromboembolismDeep-Vein Thrombosis2 moreThe presence of clots in the veins of arms and/or legs or lungs of Cancer patients decreases their quality of life, delays their treatment and may cause death. The best way to avoid new clots is by giving blood thinners before clots are formed, but even some patients who are taking blood thinners may form blood clots. A major problem is that it is difficult to know which patients form clots while they are receiving blood thinners, a situation called treatment failure. Several studies have shown that by doing blood tests that measure the formation of clots, the investigators could know if the patient is responding to the blood thinners. If this is proven, the investigators will be able to apply these tests to all patients.

An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®...
Venous ThromboembolismThe objective of this study is to observe the safety, tolerability, and compliance in the use of Fragmin® for prolonged thromboprophylaxis in post-surgery high-risk orthopedic patients.

Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip...
ArthroplastyReplacement1 moreAn observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment

Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage
Intracerebral HemorrhageTo evaluate the efficacy of using IPC during the acute phase of ICH in the prevention of VTE. To assess the safety and efficacy of additional therapy with enoxaparin. To compare the efficacy and safety of the European and American guideline recommendations. To provide an efficient and safe thromboprophylaxis for several weeks until the patient is able to walk.

Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non...
Leg InjuriesWinter Sport Resorts1 moreThe purpose of this study is to evaluate the impact of thromboembolic diseases and heparin complications in patients with a lower limb trauma supported by physicians of mountain.

Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection
ThromboembolismThis post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism. (ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)

Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly...
Brain and Central Nervous System TumorsThromboembolismRATIONALE: Patients with gliomas may be at risk for developing blood clots. Learning about the risk factors for developing blood clots may help doctors plan better treatment for gliomas. PURPOSE: This clinical trial is studying risk factors for developing blood clots in patients who are undergoing cancer treatment for newly diagnosed gliomas.

Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery
ThromboembolismUnspecified Adult Solid Tumor1 moreRATIONALE: A test that detects abnormal blood clotting in patients with cancer may help doctors plan cancer surgery. PURPOSE: This laboratory study is looking at a new blood test to detect abnormal clotting in patients with metastatic cancer undergoing surgery.

Mutations, Hormone Therapy (HRT) and Venous Thromboembolism
Cardiovascular DiseasesVenous Thromboembolism1 moreTo assess the interaction between hormone replacement therapy and the prothrombotic mutations, Factor V Leiden and the recently described prothrombin mutation (20210A) on the incidence of venous thromboembolism (VTE) in a population-based case-control study conducted at Group Health Cooperative of Puget Sound (GHC).