Phase I Study of Direct Coagulation Factor Xa Inhibitor SYHA136 Tablets in Chinese Healthy Volunteers...
Venous ThrombosisThe trial used single-center, randomized, double-blind, placebo-controlled, single-dose ascending study. The trial planned to enroll fifty-six healthy volunteers. The subjects were allocated to eight dose groups, including 0.5 mg (3+1), 1 mg (3+1), 2.5 mg (6+2), 5 mg (6+2), 10 mg (6+2), 20 mg (6+2), 35 mg(6+2) and 50 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.
Registry of Angiovac Procedures In Detail Outcomes Database-RAPID Registry
Venous Thromboembolic DiseaseDeep Venous Thrombosis2 moreVenous thromboembolic disease is a significant cause of morbidity and mortality. The purpose of the RAPID registry is to collect information on the Angiovac procedure and Angiovac device used in the treatment of deep venous thrombosis (DVT), right heart pathology and pulmonary embolism.
Study Comparing Modified Lee White Clotting Time Against Twenty Minute Whole Blood Clotting Test...
Coagulation DefectSnake Bites20 minute Whole Blood Clotting Test(20'WBCT) recommended by World Health Organisation guidelines is probably the most routinely employed bed side screening tool in the country. The Modified Lee and White (MLW) method gives a value which when performed serially gives a trend in clotting time which the investigators hypothesise to be a better tool in serially assessing the victim compared to the 20'WBCT. The investigators propose that delayed reading of both MLW and 20'WBCT to check for clot stability at 30 minutes also provides added information in management of snake bite victims.
Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
ThrombosisThis is an ADME study. Human radiolabeled mass balance studies are performed as part of drug development to obtain information about the absorption, distribution, metabolism, and excretion (ADME) of a study treatment. The goals of human ADME studies include the assessment of absorption, distribution, routes and rates of excretion, mass balance, and metabolite profile and identification.
Evaluating Dose Regimen of Intravenous Unfractionated Heparin and Low Molecular Weight Heparin in...
COVID-19Deep Vein Thrombosis2 moreTo see whether our increased dosing regimen of unfractionated heparin (UF) and low molecular weight heparin (LMWH) in COVID-19 patients was effective at preventing thrombo-embolic complications. We did regular anti-Xa tests to optimise the dose of our thromboprophylaxis. Furthermore, we want to examine the time it takes to reach adequate anti-Xa levels, to determine additional risk factors and do a subgroup analysis. Lastly, we will study if there are possible complications of our thromboprophylactic therapy.
A Study to Gather Information About Rivaroxaban in Patients in the United Kingdom Who Have Cancer...
Treatment of Venous Thromboembolism in Cancer PatientsPatients with cancer are more likely than those without cancer to develop blood clots (deep vein thrombosis and pulmonary embolism), which are treated using blood thinners (anticoagulants). When clots occur, cancer patients carry a higher risk of recurring clots and more likely to bleed on blood thinning treatments. Therefore, it is critical to use blood thinners that optimize the safety and benefits. There are two main types of blood thinners that are recommended. The tablets which are direct-acting oral anticoagulants and the injections (low molecular-weight heparin). Clinical trials show the tablets may reduce clot risk but may potentially lead to more frequent bleeding, particularly in those with certain risk factors such as stomach ulcers, previous bleeding problems, certain cancer type. We aim to examine the effectiveness and safety of the tablets versus the injections for treatment of clots in cancer patients, to better understand these treatments' benefits and risks.
Venous Thrombosis Virtual Surveillance in COVID-19
Covid19Venous Thromboembolism2 moreThe 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.
Taurolock Hep 500 Versus Unfractionated Heparin as Anti-inflammatory in Hemodialysis Catheters....
Hemodialysis Catheter InfectionThrombosis; Dialysis CatheterTo assess the efficacy of Taurolock-hep500™ as anticoagulant and antimicrobial catheter lock solution in comparison to unfractionated heparin as alock solution to improve performance of hemodialysis catheters and quality of hemodialysis .
Tumescent Anesthesia Antibiotic Delivery (TAAD)
Surgical Site InfectionThrombosis1 moreThis is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic delivery: Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food & Drug Administration (FDA) has approved our Investigational New Drug (IND) application to conduct this RCT. An IND application was necessary because subcutaneous injection of antibiotics in general, and cefazolin and metronidazole in particular are considered to be "off-label". In addition, the tumescent formulation of cefazolin (1gm) and metronidazole (500mg/100ml) in a dilute solution of lidocaine (1gm), epinephrine (1mg) in 100ml and sodium bicarbonate (10mEq/10ml) added a 1000ml bag of 0.9% sodium chloride (total volume 1210ml) is also considered "off-label." This trial will also prospectively study the HK Surgical SubQKath, an over-the-needle subcutaneous catheter specifically designed to deliver relatively large volumes of a relatively dilute TAAD solution. The TAAD trial will document the safety and efficacy of the HK SubQKath
Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs
Intracranial HemorrhageTraumatic4 moreOral antithrombotic medications (OAM) are used for the prevention and treatment of thrombotic disorders. Among hemorrhagic complications of OAMs, intracranial hemorrhage (ICH) may have particularly devastating consequences with high morbidity, disability and mortality rates. The efficacy and safety profiles of OAMs are generally assessed in randomized controlled trials (RCT), but included patients are often highly selected and may not be representative of users in everyday clinical practice in terms of follow-up routines, age, gender, drug compliance, and polypharmacy. Moreover, it is often unclear whether or not traumatic ICHs are registered and reported in RCTs. Drifts in indications and treatment criteria may also be seen in everyday practice and drug discontinuation due to precautionary concerns including compliance, fall risk and comorbidity may be forgotten. Collectively, these factors may lead to other and potentially higher traumatic ICH rates in general clinical use than reported in RCTs. The incidence rates of traumatic ICH in patients on OAMs in the general population remain unknown. In this nationwide registry based pharmacoepidemiological study we will investigate the incidence and case fatality of traumatic ICH in users of OAMs in Norway from 2008 through 2014.