Prophylactic Anticoagulation for Catheter-related Thrombosis
Venous Thrombosis Due to Central Venous Access Device (Disorder)Prophylactic Anticoagulation1 moreThe main objective of this study is to compare the efficacy and safety of aspirin, low molecule heparin and rivaroxaban for preventing catheter-related thrombosis in middle-to-high-risk ambulatory patients with cancer and implantable venous access ports.
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort
Treatment of Venous Thromboembolism in Cancer PatientsProphylaxis of Recurrent Venous Thromboembolism in Cancer PatientsPatients with active cancer are ~5-fold more likely to develop a venous thromboembolism (VTE) than those without. When VTE occurs, cancer patients carry an up to a 3-fold higher rate of thrombosis recurrence and ~twice the risk of bleeding during anticoagulation. Therefore, it is critical to utilize anticoagulants that optimize efficacy while minimizing bleeding risk when treating cancer-associated thrombosis (CAT). Guidelines list direct-acting oral anticoagulants (DOACs) as an alternative to low molecular-weight heparin (LMWH) for treatment of CAT. The strength-of-recommendation for DOACs is based on data from multiple randomized controlled trials (RCTs) comparing them to LMWHs to treat CAT, with results suggesting DOACs may reduce thrombosis risk but with potentially more frequent bleeding (particularly in those with certain gastrointestinal and genitourinary cancers). Observational studies evaluating DOACs for CAT treatment have been published, but these studies have been either single-arm, evaluated cancer subtypes not recommended for DOAC treatment, were of limited sample size and/or employed heterogeneous definitions of active cancer. We seek to evaluate the effectiveness and safety of rivaroxaban versus LMWH for CAT treatment in active cancer patients using a large de-identified electronic health record database. Retrospective cohort analysis using US Optum® De-Identified EHR data. We will use Optum EHR (electronic health records) data from November January 1, 2012 through latest available data (currently September 2020).
Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data
Deep Vein ThrombosisPulmonary EmbolusInvestigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Incidence of Deep Vein Thrombosis at Doppler Echo in Covid-19 Patients With SARS-Cov-2 Pneumopathy...
Deep Vein ThrombosisThe main objective of the study is to determine the incidence of deep vein thromboses at Doppler echo in patients with SARS-Cov-2 pneumopathy upon their entry into ICU and after 7 days of hospitalization in ICU. This is a monocentric interventional study (RIPH 2).
Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects
Stent ThrombosisIschemic Stroke2 moreThe goal of this study is to predict and prevent adverse drug events by investigating the impact of genetic variants, demographics, and environmental factors in subjects status post myocardial infarction and percutaneous coronary insertion who have experienced adverse drug events while on P2Y12 inhibitors.
CHIPs-VTE Study in Hospitalized Patients With Lung Cancer
Venous Thromboembolic DiseasePulmonary Embolism1 moreVenous thromboembolism (VTE) is a common complication of malignancies, in particular to lung cancer. Patients with lung cancer in surgical and medical departments are at high risk of VTE development. Prophylaxis is one major way to to prevent it. Currently, VTE prophylaxis is mainly based on VTE-risk assessment. However, all patients hospitalized for cancer are at intermediate or high risk of VTE but their bleeding risk vary. To improve effect of VTE prophylaxis and reduce bleeding events in patients with lung cancer, we will conduct an open-label parallel randomized clinical tria to assess the effect of bleeding risk based prophylaxis strategy among lung cancer patients. We hypothesize that VTE prophylaxis based on bleeding risk assessment with a short post-discharge treatment course is superior to VTE propohylaxis based on VTE risk assessment among hospitalized patients with lung cancer A sample of 3200 eligible patients will be randomized into experimental or control group with an allocation rate of 1:1. Stratified by medical/surgical units, block randomization with a varying block size of 4 or 6 will be adopted to randomize patients into experimental or control group. In experimental group, patients will undergo bleeding risk assessment and receive prophylaxis according to bleeding risk during hospitalization, and they will also receive an extended pharmacological prophylaxis of 5mg Rivaroxaban once daily for up to 15 consecutive days after discharge. In control group, patients will receive routine VTE prophylaxis, VTE risk assessment and prophylaxis if indicated during hospitalization according to current policies for hospitals in China but no further treatment prophylaxis after discharge. Patients in both groups will be followed up for 30 days. The primary outcome is symptomatic and asymptomatic objectively proven VTE (deep vein thrombosis (DVT) and/or pulmonary embolism (PE)) within 30 days after initiation of randomization. Ultrasound and CTPA will be performed to detect DVT and PE, respectively. Clinically relevant bleeding (non-major clinically relevant and major bleeding, HIT) and death are secondary outcomes.
Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy...
Multiple MyelomaPlasma Cell Neoplasm1 moreRATIONALE: Studying samples of blood in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how patients respond to treatment. PURPOSE: This research study is studying biomarkers related to thrombosis in patients with newly diagnosed multiple myeloma receiving chemotherapy.
Prophylaxis of Thromboembolic Complications Trial: Thromboprophylaxis Needed in Below Knee Plaster...
Deep Vein ThrombosisPulmonary EmbolismObjective: The purpose of this study is to determine the need for thromboprophylaxis in patients with a fracture of the lower extremity being treated conservatively in a below-knee plaster cast and to assess if both of the two tested prophylactic treatments are effective for this indication. Hypothesis: Nadroparine and Fondaparinux are both effective in preventing a thromboembolic event in patients with a nonsurgical fracture of a lower extremity immobilised in a below-knee plaster cast.
Coagulation Changes in Trauma Patients
Deep Vein ThrombosisHypothesis to be tested: placement of a central venous catheter will induce a systemic hypercoagulable state. To determine this, the investigators will measure thromboelastography (TEG), PT(prothrombin time), PTT (partial thromboplastin time), Prothrombin Fragment 1.2, Factor VIII, and VonWillebrand's Factor. In addition, duplex ultrasound will be performed to correlate the laboratory coagulation values with functional changes (i.e. deep venous thrombosis).
Patterns of Non-Adherence to Dual Anti-Platelet Regimen In Stented Patients
Medication Non-adherenceStent ThrombosisThe purpose of this observational research study is to determine when and why patients discontinue, interrupt, or disrupt the regimen of anti-platelet medications prescribed following stent implantation, and to examine the relationship between specific patterns of non-adherence and patient outcomes.