View clinical trials related to Hemostatic Disorders.
Filter by:A single centre, double-blind, randomized, parallel group, placebo-controlled study in healthy subjects conducted in two parts: Part 1: Single ascending doses in healthy subjects aged 18 to 49 years to assess safety, pharmacokinetics (PK) and pharmacodynamic (PD) effects of VMX-C001. Part 2: Healthy subjects aged 50 to 79 years to assess safety, PK and PD effects of VMX-C001 in the presence of DOACs.
The damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ARDS. We aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx. Furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx. The detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.
This cross-sectional pilot study will examine the blood clotting patterns in children with chronic kidney disease stages 3, 4, and 5. A total of 30 participants will be enrolled with 10 participants for each stage of chronic kidney disease. Blood specimens will be collected from each participant during a routine clinic visit, and will then be processed to evaluate blood clotting characteristics according to thrombelastography and more conventional clotting tests.
The quality of the reversion of these serious hemorrhagic accidents under oral anticoagulants depends on the adequate use of reversion products but also on the speed of obtaining hemostasis data allowing to evaluate the effectiveness of this "chemical" hemostasis. . Clot formation can be studied using different visco-elastic methodologies (thromboelastography or thromboelastometry) with a detectable change in clot formation with oral anticoagulants. These techniques have been proven in patients who are often unstable and present with severe trauma with hemorrhagic shock, thus making it possible to guide the transfusion protocol. However, the level of recommendations in these patients, who are often polyhydrated and poly-transfused, is grade 1c due to small-scale studies with difficulty in analyzing the values of the visco-elasticity parameters in these patients. In addition, these methods are little used in current practice because of their difficult reading. The use of visco-elastic methods in patients on oral anticoagulants has been little studied. However, taking an oral anticoagulant mainly causes coagulation disorders. The use of these methods would make it possible to assess the impact of the anticoagulant on hemostasis and to verify the correct reversion of hemostasis parameters. Quantra®, one of the visco-elastic methods, would make it possible to speed up the evaluation in the context of biology relocated to the patient's bed with a simplified reading of the factors involved in the formation of the clot in order to allow an immediate evaluation the quality of the reversion performed which may have an impact on the re-administration of reversion products or even an adaptation of the dose of reversion products according to the initial parameters at the time of severe bleeding before reversion. The objective of this pilot study is to study the metrological evolution, before and after reversion, of the hemostasis parameters evaluated by the Quantra® system from HemoSonics in a patient being his own control in the context of a severe hemorrhage occurring on oral anticoagulants (VKA or DOA).
Chamomile may possess anticoagulant effects based on the presence of coumarin-like compounds within the flower. This randomized, placebo-controlled complete crossover study will investigate the impact of chamomile ingestion on coagulation.
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.
The purpose of this study to evaluate the translational application of the safe and effective treatment of Narrow-Band Ultraviolet light B-band (NB-UVB) to high-risk COVID-19 patients in an effort to improve their immune and hemostatic imbalance to increase survival and improve outcomes.
Psychological stress (PSS) is one of the most common problems among healthcare providers during COVID-19 pandemic. PSS influences the homeostatic equilibrium of the body, involving activation of the sympathetic nervous system and hypothalamus pituitary adrenal (HPA) axis. Copeptin; C-terminal portion of Vasopressin (AVP) precursor is stable. Nevertheless, Evidence about influence of PSS on copeptin levels is lacking. The reason we are doing this research is to determine the level of psychological stress among healthcare providers exposed to at the time of work in intensive care unit (ICU) during COVID-19 pandemic; They will be appraised every assembly for psychological stress level; before start of duty shifts (first time), one week after start (second time) and two weeks after departure from shift duties in ICU (third time) for assessment of psychological stress level and stress hormones.
BT200 is a PEGylated aptamer that binds to the A1 domain of human von Willebrand factor (VWF). At low doses, BT200 blocks the clearance of VWF antigen (VWF Ag) from the circulation and causes an increase in concentrations of both VWF Ag and Factor VIII (FVIII), but has negligible effect on the activity of either. At higher doses, BT200 blocks clearance of VWF and also inhibits its activity, but still does not inhibit FVIII activity. Therefore, low dose BT200 could potentially be used to correct deficiency of VWF and/or FVIII in patients with hereditary bleeding disorders. This study is designed as a "basket design" pilot study to determine the relevant dose and pharmacological activity of BT200 in such patients. In this open basket study up to 25 patients with the following congenital blood-clotting disorders are to be included: Patients with hemophilia A, heterozygous carriers of hemophilia A with subnormal FVIII levels; patients with von Willebrand syndrome (VWD) type 1, "Vicenza type", and with VWD type 2b. Participants will receive BT200 subcutaneously on day 0, day 4 and day 7 in the first week and then once a week for a total of five weeks - initially in a dose of 3 mg, then in week 3 individually after response in a dose of 3 to 9 mg. Subsequently, blood samples are taken once a week for a further three weeks (wash-out phase). Patients may be enrolled in an additional pharmacokinetics sub-study. For this purpose, approximately three blood samples are taken to estimate the half-life of substituted FVIII under the influence of BT200. The primary objective of this study is to obtain clinical proof of mechanism for BT200 in one or more hereditary bleeding disorders.
No randomized controlled trial (RCT) has investigated the effect of prophylactic fresh frozen plasma (FFP) transfusion in septic or critically ill patients with coagulation abnormalities. The last Surviving Sepsis Campaign therefore suggests with a very low quality of evidence "against the use of fresh frozen plasma during septic shock to correct clotting abnormalities in the absence of bleeding or planned invasive procedures". However, expert opinion highlights that FFP should be transfused "when there is a documented deficiency of coagulation factors (increased prothrombin time, international normalized ratio - INR, or partial thromboplastin time) and the presence of active bleeding or before surgical or invasive procedures". Disseminated intravascular coagulation (DIC) is responsible for such a severe deficiency of coagulation factors. Supplementing the intense deficit of coagulation factors with plasma containing non-activated coagulation factors is therefore a rational therapy in DIC patients. OctaplasLG® is a donor plasma product, with unique features compared to standard fresh frozen plasma: standardized concentrations of natural pro-/anti-coagulation factors; a standardized volume; pathogen free. OctaplasLG® should reduce the "inflammatory hit" on the endothelium, including the glycocalyx, by having standardized levels of coagulation proteins, which can give more sustainable support to the endothelial regeneration as compared to standard fresh frozen plasma.