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89 active trials for Venous Thromboembolism

Aspirin for Prevention of Venous Thromboembolism Among Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy

This is a pilot study to determine the safety and efficacy of low dose aspirin for the prevention of venous thromboembolism among women with advanced ovarian cancer receiving neoadjuvant chemotherapy.

Start: August 2020

Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.

Start: May 2020

Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study

This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.

Start: April 2016

Study to Compare the Effectiveness of Rivaroxaban (Xarelto) Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism in Routine Clinical Practice in Germany

Researcher in this study want to compare the effectiveness of Rivaroxaban (Xarelto) versus low-molecular-weight heparin (LMWH) and phenprocoumon for the treatment and secondary prevention of venous thromboembolism by evaluating routine clinical practice data from research database in Germany. VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism). Treatment of VTE traditionally consists of acute anticoagulation treatment with heparin (mainly LMWH), followed by maintenance oral anticoagulation with vitamin-K antagonists (in Germany mainly phenprocoumon). Rivaroxaban, a direct-acting oral anticoagulants (DOAC), is an alternative VTE treatment and has been approved for both the acute and maintenance phase of VTE treatment. The study will enroll adult male or female patients who are newly diagnosed with VTE and are already on the treatment with Rivaroxaban or LMWH and phenprocoumon. Researchers are especially interested whether patients experience under treatment any VTE events or fatal bleedings.

Start: June 2020

Thrombosis Outcomes in Pediatric Venous Thromboembolism

'The TOP Study' is a prospective cohort study whose main objective is to develop better prognostic biomarkers and identify children at risk of adverse thrombotic outcomes very early in the course after an initial venous thromboembolic events (VTE). The study will compare biomarkers in children that develop poor VTE outcomes (such as recurrence, postthrombotic syndrome and post PE impairment ) after an initial VTE with those that do not develop such outcomes.

Start: May 2016

Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)

The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This study is a company sponsored, one- arm prospective cohort study with patients to whom Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).

Start: November 2015

Apixaban for the Acute Treatment of Venous Thromboembolism in Children

To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.

Start: November 2015

Prevention of Arteriovenous Thrombotic Events in Critically-Ill COVID-19 Patients Trial

This is a multicenter, open-label, 2x2 factorial, randomized-controlled trial in critically-ill patients with novel coronavirus disease 2019 (COVID-19) evaluating the efficacy and safety of full-dose vs. standard prophylactic dose anticoagulation and of antiplatelet vs. no antiplatelet therapy for prevention of venous and arterial thrombotic events.

Start: August 2020

Computerized Registry of Patients With Venous Thromboembolism (RIETE)

The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive data registry of consecutive patients with venous thromboembolism. The main objective is to provide information on the Internet to help physicians to improve their knowledge on the natural history of thromboembolic disease, particularly in those subgroups of patients who are usually not recruited in randomized clinical trials (pregnant women, elderly patients, disseminated cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of decreasing mortality, frequency of thromboembolic recurrences as well as bleeding complications and arterial events. As an additional objective RIETE is also aimed to create predictive scores that help physicians to better identify patients with high risk of presenting some of these complications. The primary parameters recorded by the registry comprise details of each patient's clinical status, including any coexisting or underlying conditions, and the type, dose, duration and outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.

Start: March 2001

Venous Thrombosis Virtual Surveillance in COVID

The overall goal of the VVIRTUOSO study is to determine the incidence of VTE including symptomatic DVT and PE after hospital discharge in patients with COVID-19 by implementing a pragmatic patient-centred prospective virtual VTE monitoring program in Canada and the United States.

Start: January 2021

Validation of the 4TS RAM in the Prevention of Venous Thromboembolism in Patients With Plasma Cell Dyscrasias.

Patients with newly diagnosed symptomatic multiple myeloma per IMWG criteria prior to therapy initiation are enrolled in the study. The aim of the study is to investigate clinical and disease related risk factors for venous thromboembolism (VTE) in these patients as well as possible biomarkers of hypercoagulability linked with the occurrence of venous thromboembolism at diagnosis and during the disease course. The purpose is to create a risk assessment model for VTE in newly diagnosed multiple myeloma patients and make the model more accurate by combining relevant clinical and disease characteristics with biomarkers of cellular and plasma hypercoagulability. A standardized clinical research form is completed for all patients at baseline, 3, 6 and 12 month follow up to include relevant clinical, patient-related, disease-related and treatment related data. Blood sampling also takes place at baseline and 3,6,12 months to assess multiple biomarkers of plasma and cellular hypercoagulability. In addition lowe limb ultrasound is performed at baseline, 6 and 12 months. The primary endpoint is VTE occurrence. Following the elaboration of the ROADMAP-CAT-MM risk assessment model we will prospectively validate it. We expect that patients who are classified, as high risk according to the ROADMAP-CAT-MM will experience symptomatic VTE more frequently and will have higher morbidity and mortality rates during the follow-up. The prospective validation of the ROADMAP-CAT-MM will provide guidance for the use and choice of thromboprophylaxis in these patients and will identify high risk patients eligible for thromboprophylaxis with low molecular weight heparin (tinzaparin). In addition to symptomatic patients with multiple myeloma the study aims to investigate VTE risk in all plasma cell dyscrasias and will recruit patients with monoclonal gammopathy of undetermined significance, asymptomatic multiple myeloma, primary amyloidosis and Waldenström's macroglobulinemia.

Start: June 2014

RIVET-Case Control Study

The risk of venous thromboembolism (VTE) associated with the use of chlormadinone acetate (CMA) is currently unknown as the available data have significant limitations and lack data on direct comparison between levonorgestrel (LNG) and CMA containing COCs. This new study is designed to assess the VTE risk associated with CMA containing COCs compared to LNG containing COCs in a large case-control study. The objective of this study is to compare the VTE risk of COCs containing CMA 2mg / EE 30µg, compared to COCs containing LNG 0.15mg and 30µg ethinylestradiol (EE).

Start: June 2016

A Universal Electronic Health Record-based IMPROVE VTE Risk Assessment Model for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients

This study will be a multicenter clustered randomized trial of patients in hospitals in which a universal "SMART on FHIR" platform-based EHR-embedded IMPROVE DD VTE clinical prediction rules (CPRs) with electronic order entry has been incorporated into required admission and discharge EHR workflow versus hospitals following UMC for VTE risk assessment of medically ill patients. The patient population will consist of hospitalized, medically ill (non-surgical, non-obstetrical) individuals aged > 60 years.

Start: December 2020

Cancer Associated Thrombosis : What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO

Venous thromboembolism is a common and fatal disease closely related to cancer. The therapeutic challenge is major due to the high risk of recurrent thromboembolism and bleeding in patients with cancer. Guidelines recommend the use of low molecular-weight heparin for the treatment of Cancer-Associated venous Thromboembolism (CAT) at least for 3 to 6 months of treatment. However, recent advances through the results of several therapeutic trials such as CARAVAGGIO (NCT03045406) open the door to the use of Direct Oral AntiCoagulants (DOACs) as first-line therapy. Nevertheless, extrapolation of its results may be limited owing to a large number of inclusion and exclusion criteria, which may have selected a reduced population. The proportion of patients admitted with acute CAT who may not eligible to a trial as CARAVAGGIO is unknown.

Start: April 2021

LEAVE Safe With DOACs

Given the risks associated with direct oral anticoagulants (DOAC)s and the lack of defined pathways for patients prescribed this class of medications, the study intervention has the potential for enormous impact in preventing medication errors and improving the quality of care transition, patient knowledge, and adherence with DOAC therapy.

Start: December 2019

Clotting Parameters After Medical Abortion

Venous thromboembolism (VTE - blood clots that form in deep veins or in the lungs) has been identified as a leading cause of death in economically developed countries for pregnant and recently-pregnant women. There is evidence that clotting parameters can take up to 6 weeks to return to normal for women who have had term deliveries, however there is an absence of information on time taken for clotting parameters to normalise following abortion. As such, existing guidelines are based solely on expert opinion and recommend durations of VTE prevention from as short as 7 days, up to 6 weeks following abortion. All women are assessed for risk of VTE, but data are needed to inform an evidence-based approach to prevention of VTE in these women. The findings from this pilot study have the potential to inform clinical guidance and possibly a larger study subsequently.

Start: March 2021

Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait

Background: Venous thromboembolism (VTE) includes the abnormal clotting of blood in a deep vein of the upper or lower limbs (deep vein thrombosis) that may travel to and block a blood vessel in the lung (pulmonary embolism). Some people with sickle cell disease (SCD)-a red blood cell disorder-seem to be at greater risk for developing these blood clots. Researchers want to study the blood of people with SCD and VTE as well as healthy people to develop better treatments to prevent blood clots. Objective: To study blood clotting in SCD because it is the most common cause of vascular death after a heart attack or stroke. Eligibility: People ages 18-80 who have SCD (with or without a history of blood clots) or the trait for SCD, and healthy volunteers Design: Participants will be screened with medical history, physical exam, and medical records review. They will give blood samples. Participants will have phone calls either every 3 months or once a year, for 2 years. They will give updates on their health. They may give additional medical records. The phone calls may last up to 30 minutes. If participants have a VTE or pain crisis episode, they may visit the Clinical Center. These visits may last up to 4 hours. They will repeat the screening tests and give blood samples. Some participants may be invited to take part in blood studies. After 2 years, some participants will have a follow-up visit at the Clinical Center. Participation will last for about 2 years.

Start: September 2020

A Clinical Cohort Study of Safety and Effectiveness of Venous Thromboembolism Prophylaxis in Critical Ill Patients

The purpose of this study is to analyze the effect of the prophylaxis of venous thromboembolism in the critical ill patients, and at the same time, to find out the risk of venous thromboembolism and hemorrhage events occurred under the prophylaxis.

Start: November 2014

START-Register: Survey on Anticoagulated Patients Register

This is a phase 4 cohort prospective, open, national, multicentre study that collects data on history of patients treated chronically with anticoagulant drugs, including the novel direct oral anticoagulants (DOACs). The Registry is designed solely for observational purposes and is not intended to have any influence on the treatment of the single patients included. Patients are included when they start the anticoagulant treatment, whatever the drug used, or when they shift from a vitamin K antagonist (VKA) drug to one of the novel direct oral anticoagulants, provided that the therapy is expected to last at least 3 months. The general aims of the study are to provide a better evaluation of efficacy and safety of different treatment options, and to improve our understanding of the risks/benefits of the various anticoagulant drugs and the different therapy options. The Registry is open to the participation of clinical centres or individual professionals (now called Participants) that are involved with management of anticoagulated patients.

Start: October 2011

Apixaban for Extended Anticoagulation (APIDULCIS)

The study aims at optimizing the long-term and extended management of patients with a first episode of venous thromboembolism (proximal deep vein thrombosis with or without pulmonary embolism) (VTE). Patients at high risk of recurrence (with altered D-dimer test), who had received anticoagulation (whatever the drug used) for 12-15 months after the first episode of thrombosis, will be treated with Apixaban 2,5 mg x 2 for 18 months as extended treatment. Patients at low risk, with normal D-dimer test, will stop anticoagulation definitely.

Start: August 2018