A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.
ArthroplastyReplacement2 moreThe goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.
Postmenopausal Estrogen/Progestin Interventions (PEPI)
Bone DiseasesCardiovascular Diseases9 moreTo assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
The Angel® Catheter Pivotal Clinical Trial
Pulmonary EmbolismDeep Vein Thrombosis2 moreThe primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).
Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)...
Pulmonary EmbolismThromboembolism3 moreThis is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial
Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries
Deep Vein Thrombosis (DVT)Pulmonary EmbolismThe use of prophylaxis for venous thromboembolism (VTE) remains grossly underused for women who undergo gynecologic surgery for benign conditions world wide and especially in developing countries including our region. Having a research in our locality for the first time might raise awareness of the importance of VTE prophylaxis.
EXercise Training for the Prevention of Cancer Thrombosis (EXPECT) Pilot Trial
Cancer ThrombosisPatients with lymphoma or cancer who are receiving chemotherapy in the outpatient setting are at risk for blood clots which form in the veins. The occurrence of blood clots has major implications on personal health including the need for blood thinners and monitoring, potential bleeding, and complications related to blood clots on cardiovascular health. The goal of this study is to determine whether aerobic exercise training is a therapeutic strategy to offset risk of blood clots and improve quality of life among cancer patients during chemotherapy.
Diagnosis Exclusion of Recurrent Deep Vein Thrombosis of the Lower Limbs
Deep Vein ThrombosisThe 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.
Safety and Efficacy Study of AB002 (E-WE Thrombin) in End Stage Renal Disease Patients on Chronic...
End Stage Renal DiseaseThrombosisThis study evaluates the safety and efficacy of AB002 (E-WE thrombin) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts. Within each cohort the patients will be randomized to receive either AB002 (E-WE thrombin) or placebo (at a ratio of 2:1 active: placebo).
Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients
NeoplasmsThe study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among cancer patients.
Isometric Preoperative Exercise on Autologous Arteriovenous Fistulas. Randomized Clinical Trial...
Arteriovenous Fistula ThrombosisArteriovenous Fistula StenosisA good vascular access (VA) is vital for hemodialysis (HD) patients. The start of HD with autologous arteriovenous fistula (AVF) means higher survival, lower sanitary costs and complications. The distal forearm AVF is known as the best option but not all patients are good candidates for this surgery, and there is a primary failure rate between 20 and 50% published in literature. The choice of the optimal AVF for each patient is conditioned mainly by the anatomical and hemodynamic characteristics of the artery and the vein chosen to perform the anastomosis. These characteristics can be modified by performing physical exercise Some vascular access guidelines suggest the performance of isometric exercises in the pre and postoperative period of the AVF confection. However, there is very little data in literature on the possible efficacy of preoperative exercise, although small published observational studies point to an improvement in the venous and arterial caliber. Regarding the postoperative exercises, they do seem to improve maturation, however the degree of evidence in literature is low and there is no consensus on the exercise protocol to follow. We present an open-label, multicenter, prospective, controlled and randomized study in order to evaluate the usefulness of preoperative isometric exercise (PIE) in pre-dialysis patients or in prevalent HD with indication of performing a new AVF. The randomization will be 1: 1, one group of patients will perform PIE for 8 weeks and the other group of patients will be a control group. The main purpose will be to evaluate if there is a lower rate of primary failure in the PIE group compared with control group.