View clinical trials related to Thrombosis.
Filter by:The proposed trial is a pragmatic, registry linked, prospective, randomized (1:1) controlled, open-label parallel group clinical trial with blinded endpoint assessment of 1600 patients to test if intravenous tenecteplase (0.25 mg/kg body weight, max dose 25 mg) is non-inferior to intravenous alteplase (0.9 mg/kg body weight) in patients with acute ischemic stroke otherwise eligible for intravenous thrombolysis as per standard care. All patients will have standard of care medical management on an acute stroke unit. There are no additional trial specific management recommendations. Patients will be followed for approximately 90-120 days.
Patients undergoing electrophysiology studies (EPS) and cardiac ablation procedure for the treatment of cardiac arrhythmias may be at increased risk of deep vein thrombosis (DVT) during or after the procedure, which may lead to pulmonary embolus which can be life threatening. The study will use Doppler ultrasound scanning at 24h and between 10-14 days post EPS and cardiac ablation to assess the incidence of undiagnosed DVT. A positive finding may provide support for a larger clinical trial to assess the benefit of prophylactic anticoagulation post EPS procedure.
The purpose is to assess the safety of a management strategy based on colour doppler ultrasound (CDUS) and D-Dimer test results for the diagnosis exclusion of recurrent deep vein thrombosis (DVT) of the lower limbs. DVT recurrence requires using anticoagulant treatment to prevent thrombosis progression. Given an increased bleeding risk with prolonged treatment, an accurate diagnosis for recurrence is needed. However, the diagnosis of a new thrombosis in a previously involved leg is difficult. Imaging modalities and criteria that are currently used for the diagnosis may be equivocal and unable to discriminate between an old clot and a new one recently developed at the same site. An increase in vein diameter after vein compression by the ultrasound probe was suggested as a diagnostic criterion for a new DVT. This method has many limitations in clinical practice, mainly a lack of availability of a previous measurement and a poor inter-observer agreement. Colour Doppler ultrasound enables to study both the thrombus and the blood flow characteristics that might help to overcome these limitations. CDUS is a well-known method for the diagnosis of vascular diseases and is used in every day clinical practice for the diagnosis of a first DVT and DVT recurrence but CDUS has never been assessed for DVT recurrence in a study. The diagnosis of DVT recurrence may be easily established using the same criteria as for a first DVT episode. Our hypothesis is that CDUS associated with D-Dimer can safely rule out the diagnosis of DVT recurrence while maintaining a good specificity. The strategy consists in performing first a CDUS that helps to classify patients as having (positive CDUS) or not having (negative CDUS) a new thrombosis. In the case of an equivocal CDUS, a D-Dimer test is performed. If the D-dimer is normal, the diagnosis of DVT recurrence is ruled out and the patient is not treated. If the D-dimer is abnormal, the diagnosis cannot be excluded nor confirmed and a second CDUS is performed on D7±2. Meanwhile, patients are not treated by anticoagulants. An unchanged CDUS on D7±2 qualifies patients as free from a new DVT and they are not treated. Conversely a change in CDUS qualifies patients as having a new DVT which requires anticoagulant treatment. All patients have a 3-month follow-up for the assessment of potential venous thromboembolic events.
Inflammation is a normal immune response to tissue healing. However, uncontrolled and unresolved inflammation can initiate and further induce several chronic manifestations that contribute to chronic disorders such as atherosclerosis and cardiovascular disease (CVD). A 'cross-talk' between platelets, endothelial cells and leukocytes, accompanied by activation and aggregation of platelets, contribute to inflammation-related atherogenic, atherosclerotic and athero-thrombotic events. Platelet Activating Factor (PAF) and Thrombin are the most potent platelet agonists inducing platelet activation and aggregation that are also implicated in the patho-physiology of platelets and endothelium and thus in inflammation-related chronic disorders. Therefore, the inhibition of PAF and Thrombin related pathways of platelet aggregation, coagulation and inflammation provide a potential therapeutic strategy for anti-platelet, anti-coagulation and suppression of inflammatory responses in CVDs and other chronic disorders. The investigators have previously reported bio-active lipid molecules with strong anti-PAF and anti-Thrombin effects to be present in natural, non-toxic food, microorganisms, plants and especially in several marine sources. The plethora of in vitro beneficial bio-activities of marine polar lipids (PLs) against atherosclerosis and CVDs indicate therapeutic potential. Recently, the investigators have also demonstrated that PLs extracted from Irish, organic farmed salmon (Salmo salar) display strong in vitro anti-thrombotic effects against platelet aggregation, bio-activities that were related to inhibitory effect against PAF and Thrombin pathways. The present study investigates the putative anti-platelet effects in healthy human subjects following ingestion of a novel supplement containing food-grade extracts of bio-active salmon polar lipids (FGE-Salmon-PLs). The study has a double blind randomized cross-over placebo-controlled design in healthy subjects. Each Subject will be administrated the FGE-Salmon-PLs Food Supplement capsules for 28 days (a capsule containing 0.125 g of FGE-Salmon-PLs per day) and platelet sensitivity against both PAF and Thrombin will be tested in blood samples of each subject just before and after the supplement administration. The same tests will be conducted in blood samples of each participant in a crossover design before and after 28 days of placebo capsules administration (a capsule containing 0.125 g of glycerin per day).
The aim of this study is to report the clinical presentation, Microbiological, laboratory and imaging evaluation, prothrombotic factors analysis, medical and surgical management and outcomes in children with Otogenic Cerebral Sinus Vein Thrombosis (CSVT).
Covered stents (CS) are a potentially lifesaving treatment for grade III coronary perforation but delivery can be challenging, and the long-term durability and safety including risk of acute stent thrombosis are unknown. The GNOCCI study aims to evaluate long term outcomes after coronary perforation including patients treated with covered stents.
A well-functioning vascular access is essential for providing adequate life-sustaining treatment in patients with end stage renal disease on maintenance hemodialysis. The preferred long-term vascular access is the arteriovenous fistula (AVF), which is created using the vessels of the patient by surgically connecting an artery with a superficial vein to increase the blood flow (Qa) in the venous system, which will dilate allowing the insertion of two needles, one to carry the blood to the dialyzer, and the other to return the cleansed blood to the body with the aid of a dialysis machine. Unfortunately, the high prevalence of vascular disease of the hemodialysis patients make difficult to create an adequate AVF in as many as 20 to 60% of the patients.In these persons, a valid alternative is the arteriovenous graft: in graft method an artery is surgically connected to a vein with a short piece of synthetic soft tube which is implanted under the skin. Needles are inserted in the graft during the dialysis treatment. Compared to an AV, however, graft is at higher risk of complications. The most frequent complication is thrombosis (i.e. the formation of blood clot inside the graft). Usually, thrombosis is the consequence of an underlying significant stenosis (i.e. a greater than 50% narrowing of the vessel or graft lumen by comparison with the lumen of a normal adjacent vessel or graft) and its hemodynamic consequences of decreasing the access blood flow (Qa) and/or increasing pressure within the graft. Therefore, all vascular access guidelines recommend regular noninvasive screening programs of grafts for timely identification of a stenosis associated with some type of functional or hemodynamic impairment, because its repair may prevent thrombosis and lengthen the useful life of the access. Screening methods include clinical monitoring and surveillance, which uses special equipment either to assess the hemodynamic consequences of stenosis by measuring Qa and static venous intra-access pressure ratio (VAPR) or to visualize the stenosis by means of duplex ultrasound (DU). Guidelines also state that there is insufficient evidence to prefer one method to another due to the lack of adequate comparative studies. The purpose of our study is to identify an optimal screening program for stenosis detection and elective repair by comparing the diagnostic performance for stenosis and incipient thrombosis of all the available screening tools in the same graft population
Blood clots occurring in the legs and in the lungs are relatively common; they occur in around 3 in a 1000 people per year. They can cause disability and are also potentially life threatening. When a clot occurs in the legs it is called a deep vein thrombosis or DVT. When they occur in the lungs they are called a pulmonary embolism or PE. The risk for DVT and PE is higher in people with conditions which cause inflammation. The most common of these are inflammatory bowel disease (ulcerative colitis and Crohn's disease), rheumatoid arthritis, and psoriatic arthritis (a condition comprised of psoriasis and joint inflammation). What is not known is how much higher the risk of DVT and PE is in these groups compared with people without inflammatory disease, and what causes the excess risk in these people. This study aims to assess the measure the exact increase in risk for DVT and PE in people with these inflammatory conditions and to identify which risk factors are most strongly associated with the increased risk. These data should help with an understand the causes of blood clot risk in these inflammatory conditions and in identify targets for reducing risk.
The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200 cancer patients, about 5 times higher than in the general population. These events are of crucial importance, since nearly 10% of cancer patients died from thromboembolic events (EVT), making them the second leading cause of death in this population. In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% - 2% before 1990 to 4% since 1990. Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients. Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy. In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified. Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet aggregation (AGP) and / or direct oral anticoagulant (AOD). In this study, the investigator means by hypocoagulability any situation modifying the normal coagulation system.
Immune thrombocytopenia (ITP) is a rare autoimmune disease (annual incidence: 3-4/105 inhabitants) leading to an increased risk of spontaneous bleeding. ITP is said "primary" when not associated to other systemic disease (lymphoma, systemic autoimmune disease, chronic infectious disease…). First-line treatment is based on corticosteroids. Intravenous immunoglobulin (IVIg) is added in case of serious bleeding. In about 70% of adult cases, ITP becomes persistent or chronic (lasting >3 months and >12 months, respectively). Second-line treatments are then indicated. Among them, thrombopoietin-receptor agonists (TPO-RAs), romiplostim and eltrombopag are increasingly used. Splenectomy is used as ultimate treatment. Paradoxically, the risk of thrombosis is higher in ITP patients in comparison with the general population, due to the release of young hyperactive platelets from bone marrow. The incidence of thrombosis in ITP patients has been estimated between 0.5 and 3/100 patients-years. However, risk factors for thrombosis in ITP are not known, except splenectomy that is used in very few patients now. The role of other ITP treatments in thrombosis occurrence has been evoked, particularly for corticosteroids and IVIg. TPO-RAs have been associated with a risk of thrombosis in clinical trials and pharmacovigilance studies, even in case of low or normal platelet count. However, this risk has not been measured in the real-life practice, adjusted for other risk factors for thrombosis.