View clinical trials related to Venous Thromboembolism.
Filter by:This is a local, prospective, multicenter, non-interventional, observational study. Primary objective is to describe how in "real life" thromboprophylaxis is carried out after the discharge from a hospital in the patients who undergo elective knee and hip replacement and who receive Xarelto during hospitalization.
Rationale: After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous thromboembolism (VTE) or deep venous thrombosis (DVT) potentially resulting in a fatal pulmonary embolism (PE). Two novel agents, dabigatran and rivaroxaban, recently gained market authorisation for prevention of venous thromboembolism after knee arthroplasty. However, there are no clinical trials with dabigatran and/or rivaroxaban and the comparator nadroparin. Nadroparin is used in the most Dutch departments of orthopaedic surgery after total knee arthroplasty. Also safety of the new oral agents with long term use of 42 days is not available for total knee arthroplasty. Our aim is to compare the long term use of dabigatran and rivaroxaban versus nadroparin on safety after total knee arthroplasty (TKA) in a clinical explorative pilot study by observing the incidence of major bleeding and clinical relevant non-major bleeding using a standardized model of bleeding definitions. Objective: The primary objective of this study is to compare the clinical safety with long term use of the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus subcutaneous administered nadroparin by observing the incidence of major bleeding and clinical relevant non-major bleeding in patients after knee arthroplasty surgery. The secondary objectives of this study are effectivity of the agents, compliance, hospital stay, re-hospitalisation, outpatient clinic visits and interventions following complications. Additionally, coagulation monitoring, knee flexion range of motion, Knee injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS) and relationship between health statuses and surgery parameters will be evaluated. Study design: The study is designed as non-inferiority randomized open label controlled pilot study. A total of 150 patients will be included, 50 patients in each treatment group (dabigatran, rivaroxaban and nadroparin). Study population: Patients ≥ 18 years and weighing more than 40 kg, participate in the 'joint care program' for primary elective total knee arthroplasty and want to provide signed informed consent are eligible for the study. Intervention: Patients receive subcutaneously nadroparin or oral rivaroxaban or oral dabigatran after knee replacement surgery. Main study parameters/endpoints: The primary safety outcome is the incidence of bleeding events occurring during the study period of 135 days (including follow-up). Major bleeding events and clinically relevant non-major bleeding events were defined according to accepted guidelines.
The purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and effectiveness of fondaparinux injection in patients with venous thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom fondaparinux was injected 10 mg/day. ("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)
The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE). ("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)
The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central line catheter. The device is designed to be placed in the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The primary endpoint is freedom from serious adverse events (SAE), defined as death, symptomatic pulmonary embolism or major bleeding .
Venous thromboemboli (VTE) are abnormal blood clots that commonly form in the blood vessels of the legs or lungs. They can block normal blood flow, damage organs, and even cause death. The risk of VTE is increased in people who are sick or immobile. VTE is the most common preventable cause of death in hospitalized patients, and its VTE prevention should be a top patient safety priority. Though there is good evidence that injectable blood thinners and/or compression stockings can prevent VTE, over 30% of hospitalized medical patients in Hamilton, Ontario receive inappropriate prevention. Hamilton Health Sciences Corporation is in the process of introducing "electronic order sets" - computer programs that help doctors order medications and other healthcare interventions for their patients. The investigators would like to study if these electronic order sets can help improve the rate of appropriate VTE prevention in hospitalized medical patients. The investigators will examine the rate before and after the introduction of electronic order sets at the Juravinski Hospital and the Hamilton General Hospital. Doctors at the Hamilton General Hospital will also get to use an additional computer program, called a computerized decision support system (CDSS), that helps them decide on the best strategy to prevent VTE in individual patients. The rates of VTE prevention at each hospital will be compared to each other, and to the rates at St. Joseph's Healthcare Hamilton, which will receive neither the order sets nor the CDSS.
Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months. International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH.
It is not known how to best restart warfarin after temporary withdrawal. Participants will be randomized to two groups. Group 1 will restart warfarin at their usual maintenance dose, group 2 will restart warfarin at double their maintenance dose for two days followed by their usual maintenance dose. The main outcome parameter will be the number of patients who are back in therapeutic INR (international normalized ratio) range 4, and 9 days after restarting anticoagulation with warfarin. Thromboembolic and/or bleeding events will be recorded as additional parameters. These data will be collected by a standardized telephone interview at 1 month. In addition, the investigators will evaluate a possible prothrombotic state by measuring the potential of thrombin generation and D-dimers in the subset of patients visiting HHS-General Hospital for their INR tests.
Venous thromboembolism (VTE) has considerably harmful effects on morbidity and mortality of cancer patients. Several guidelines recommendations have been made about the use of anticoagulation for the prevention and treatment of VTE in Western patients with cancer. In Western VTE guidelines, all solid cancer patients receiving abdominal major surgery are strongly recommended to receive pharmacologic prophylactic anticoagulation such as low molecular weight heparin (LMWH) in the perioperative periods. These guideline recommendations are based on high incidence of postoperative VTE development in Western cancer patients. However, there have been many cumulative data about the effect of different ethnicity on the VTE development and more and more investigators and clinicians admit that Asian ethnicity has lower incidence of VTE than Western ethnicity. Therefore, it may not be advisable to apply Western guidelines as it is to the clinical situation of Asian cancer patients. Although gastric cancer is the common cancer in Asia, there is no prospective data on the incidence of VTE development during the postoperative period of gastric cancer surgery. In other words, Asian doctors including Korean clinicians don't know the exact incidence of surgery-related VTE. From their clinical experiences, most Korean surgeons think that the incidence of postoperative VTE development is rare. They also have much concern about the complications such as bleeding that might be caused by routine use of pharmacologic thromboprophylaxis during the perioperative periods. Therefore, in most clinical situation, Korean surgeons do not perform perioperative pharmacologic thromboprophylaxis using LMHW. Considering these clinical situations in Korea, the uncritical acceptance of Western guidelines is inappropriate. The necessity of pharmacologic thrombo-prophylaxis can be answered only from the results of the prospective study on the incidence of postoperative VTE development after gastric cancer surgery. Moreover, current surgical trend in cancer patients is minimally invasive approach such as laparoscopic surgery. However, the necessity of pharmacologic thromboprophylaxis in patients receiving laparoscopic cancer surgery has not been evaluated even in Western countries. Western guidelines also cannot exactly answer whether pharmacologic thromboprophylaxis is really necessary in cancer patients receiving laparoscopic cancer surgery. On above backgrounds, this study was designed.
This prospective randomized study aims to determine whether intermittent pneumatic compression (IPC), 75 patients, beneath functional bracing compared to treatment-as-usual in plaster cast, 75 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote healing of sutured acute Achilles tendon ruptures. At two weeks post surgery, the IPC intervention will be ended and both patient groups will be immobilized in an orthosis until follow-up at six weeks. The endpoint of the first part of the study is VTE events. The primary outcome will be the DVT-incidence at two weeks, assessed using screening compression duplex ultrasound (CDU) by two ultrasonographers masked to the treatment allocation. Secondary outcome will be the DVT-incidence at 6 weeks. 1) Deep Vein Thrombosis (DVT) detected by CDU , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography. The endpoint of the second part of the study is tendon healing quantified at 2 weeks by microdialysis followed by quantification of markers for tendon repair. The endpoint of the third part of the study is the functional outcome of the patients at one year post-operatively using four reliable and valid scores, i.e. the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group's questionnaire (EQ-5D) as well as the validated heel-rise test.