Active clinical trials for "Thromboembolism"

Venous thromboembolism (VTE) is a common cause of morbidity and mortality among critically ill patients. No uniform standard model of VTE risk for critically ill patients was formatted by now. In 2020, Viarasilpa et al. developed the ICU⁃VTE rating table, mainly for ICU patients. However, it lacks validation. We examined and compared how well the ICU-VTE score predict and stratify VTE risk in comprehensive ICU patients.

This study will assess the safety and effectiveness of a drug called apixaban for the treatment of upper extremity deep vein thrombosis (UEDVT) and clinically important bleeding. Subjects will receive apixaban 10 mg by mouth twice a day for 7 days, followed by 5 mg by mouth twice a day for a duration of 11 weeks. There will be a followup visit at 12 weeks for all participants. A total of 375 are to be enrolled. The study drug has been approved to treat blood clots. The study drug has not been studied uniquely for the treatment of blood clots in the upper extremity however. Because it is unknown whether it is effective to treat blood clots in the upper extremity, the principal investigator cannot guarantee that there will be benefit to study subjects; however, it is hoped that the information obtained from this research study will help treat patients in the future.

This is a pilot, randomized, open-labelled study. Eligible patients will be enrolled and randomized 1:1 into "anticoagulation" arm or "anticoagulation plus atorvastatin" arm, with atorvastatin given at 40 mg orally daily for 3 months. The targeted total accrual is 80 patients, with 40 in each arm. Patients will be recruited from the hospitals and clinics at The Ohio State University Wexner Medical Center. Follow up visits are planned at enrollment, 3 months, and 9 months after randomization. At each follow up, blood will be obtained and assessments will include structured interviews of signs and symptoms of recurrent venous thromboembolism (VTE), bleeding, post thrombotic syndrome, and adverse events from study drugs.

The Researchers are studying whether a vascular boot warming program plus standard of care anticoagulation can be a safe and effective method to resolve Deep Vein Thrombosis (DVT) ±Pulmonary Embolism (PE) earlier and prevent development of post-thrombotic syndrome (PTS). Additionally, to learn whether a more detailed imaging of the affected lower extremities will provide a more accurate and reliable method to guide treatment for this condition.

Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate evidence. More than 12 months of treatment are currently recommended, and the grade of recommendation is low. The PROLONG study has recently evaluated the predictive role of D-dimer measurement after withholding oral anticoagulant treatment in patients with a first episode of VTE. Patients with a positive D-dimer had a significantly higher incidence of VTE recurrences than patients with a negative D-dimer and required resumption of the antithrombotic treatment. Based on the results of this and of previous cohort studies, it appears safe to withhold treatment in patients with negative D-dimer values and to continue treatment in patients with altered D-dimer levels. Aim of this study is therefore to assess the negative predictive value of D-dimer also in patients with recurrent VTE and to evaluate the clinical utility of this approach in this patient setting.

Background Patients with cancer and a first deep venous thrombosis of the leg or pulmonary embolism (venous thromboembolism, VTE) are generally treated with low molecular weight heparin (LMWH)injections for 6 months, since this treatment is associated with a reduced incidence of recurrent VTE compared to vitamin K antagonists (VKA). It is recommended that patients with active malignancy (metastatic cancer and/or ongoing cancer treatment)continue anticoagulant treatment. However, it is unknown whether LMWH is still superior compared to VKA for the long-term anticoagulant treatment. Aim The aim of this study is to evaluate whether low-molecular-weight heparin more effectively reduces recurrent VTE compared to vitamin K antagonists in patients with cancer who have already completed 6 to 12 months of anticoagulant treatment because of deep venous thrombosis of the leg or pulmonary embolism. Hypothesis The investigators hypothesize that LMWH is more effective compared to VKA in the long-term treatment of VTE in cancer patients who have already been treated for 6-12 months with anticoagulants. Design This is a multicenter, multinational, randomized, open label trial. Patients Patients with a malignancy (all types, solid and hematological) who have received 6-12 months of anticoagulation for VTE and have an indication for continuing anticoagulation, will be randomly assigned to six additional months of LMWH or VKA. LMWH will be administered in a weight-adjusted scheme, with 65-75% of therapeutic doses. All types of LMWH and VKA are allowed, as long as weight adjusted dosing is possible for LMWH. The target INR will be 2.0-3.0. The primary efficacy outcome is symptomatic recurrent VTE, i.e. deep vein thrombosis and pulmonary embolism. The primary safety outcome is major bleeding. Sample size A total of 65 to 87 recurrent VTE events are needed to show a 50% reduction with LMWH as compared to VKA (type I error 0.05, two-sided, power respectively 80 and 90%). To observe 75 events, with a 10% event rate per half year in the VKA arm and 5% in the LMWH arm a total of 1000 patients will need to be included. Organisation Outcomes will be adjudicated by a central adjudication committee. A steering committee will be formed, preferably consisting of one member of every participating center. An electronic case report form will be used for data collection. Also, an electronic trial master file will be used.

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may help prevent blood clots in patients being treated with gemcitabine for unresectable or metastatic pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without dalteparin in treating patients who have unresectable or metastatic pancreatic cancer.

This is an observational study in which data from people with atrial fibrillation who received or are currently receiving the drug apixaban to prevent thromboembolic events (blood clots that travel through the blood stream to plug another smaller vessel) are studied. In observational studies, only observations are made without specified advice or interventions. Atrial Fibrillation (AF) is a condition of having irregular and often rapid heartbeat. AF can lead to the formation of blood clots in the heart and to embolism, a condition that happens when a blood clot travels through the blood stream to plug another smaller vessel. This can lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from AF can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. This is a complex series of steps that must occur in a specific sequence. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs). OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding. In the beginning, there was only one main class of OAC called vitamin k antagonists (VKAs) prescribed in usual practice. VKAs work by lowering the number of coagulation factors in the blood. Over the years, newer OAC medications have become available which act more specifically by interrupting one or more of the coagulation steps and preventing the blood from clotting. The study treatment apixaban works by blocking a very specific step in the blood clotting process, the activation of a protein called Factor Xa. Newer OACs are also called direct oral anticoagulants (DOACs). DOACs require less monitoring by doctors, but an increased risk of bleeding remains. Bleedings can be an important reason for stopping therapy. One type of bleeding called patient relevant bleeding (PRB) has not been intensely studied so far. PRB is a type of minor bleeding which is bothersome, but which does not require medical treatment as it has no important impact on a person's health. It needs to be distinguished from so called clinically relevant non-major bleeding (CRNMB). CRNMB stands for a type of bleeding which may have an important impact on a person's health and needs medical attention, but when treated, is not likely to have a negative impact on a person's health. Only limited information is available for PRB and CRNMB related to the treatment with DOACs in real-world settings. In this study, researchers want to collect more data about how often PRB and CRNMB occur in people with AF treated with apixaban. In addition, researchers want to learn how these medical problems affect the treatment with apixaban under real-world conditions. To do this, researchers will count the number of participants in usual practice who have PRB or CRNMB and who are being treated with apixaban at the time of this ongoing study or who have recently taken this drug, but have switched to another OAC, who have PRB or CRNMB and have decided to stop or to continue their treatment with apixaban. In addition, characteristics of each participant and the reason for continuation or discontinuation of apixaban will be collected and described. The data for this study will come from patient surveys. Besides this data collection, no further tests or examinations are planned in this study. The participants who take their apixaban treatment during this study will receive their treatments as prescribed by their doctors during routine practice according to the approved product information. The data will be from participants who will be identified for the survey using last 12-months data from the database called HealthCore Integrated Research Database (HIRD). The data will be collected for each participant for 12 months before the participant starts the survey. The study will end as soon as the planned number of surveys has been reached or at the end date of the study.

In renally impaired patients with acute venous thromboembolism (VTE), standard-of-care (SOC) anticoagulation, i.e. heparins-vitamin K antagonists (VKA), at therapeutic dosage is associated with an increased risk of thromboembolic and bleeding complications compared to patients with normal renal function. Direct oral anticoagulants (DOAs) have been shown to be at least as effective and safe as SOC in VTE treatment. But in the clinical trials, moderate renally impaired patients were poorly represented and patients with severe renal insufficiency not at all. So no dose reduction was considered. Surprisingly, DOAs have been approved for VTE treatment in moderate and severe renally impaired patients. There is need to evaluate a reduced dose of DOAs for VTE treatment in patients with moderate and severe renal insufficiency. We plan to evaluate reduced doses of 2 DOAs (apixaban, rivaroxaban) compared to SOC in VTE patients with moderate or severe renal insufficiency in terms of net clinical benefit (recurrent VTE and major bleeding) at 3 months.

Approximately 2 million patients in North America are currently treated with the blood thinner warfarin. These patients have every year more than 200,000 invasive procedures, for which warfarin must be stopped to avoid bleeding complication. To protect the patient against blood clots and stroke while warfarin is stopped, most physicians today order "bridging" with low-molecular-weight heparin (LMWH). This is another blood thinner and it is injected under the skin during 3 days before the procedure. For implantation of pacemaker or defibrillator (27,000/year in Canada) the "bridging" routines vary a lot.The common "bridging" treatment with LMWH for 3 days before pacemaker surgery causes bleeding in the "pocket" where the pacemaker is placed in about 5%. For comparison, patients not on any blood thinners develop this bleeding in 2% after this surgery. "Pocket bleeding" may require evacuation of the blood collection and may cause infection. "Pocket bleeding" is thus a fairly common and clinically important but rarely a dangerous bleeding complication. It is a suitable safety endpoint in a study of "bridging" of blood thinners. LMWH costs $80-120, for which some patients are not covered. They have to be taught self-injection technique or have a nurse come to their home. The main hypothesis is if patients on blood thinners can be managed more conveniently before and after pacemaker surgery, without injections, without increased risk of pocket bleeding.