Active clinical trials for "Hemostatic Disorders"

The aim of the study is to test if patients under oral anticoagulation therapy who are going to participate in the education program will have better Health-related quality of life, higher rate in pharmacological treatment adherence and better self efficacy to manage the treatment.

Frozen plasma (FP) is commonly transfused to patients with abnormal coagulation results prior to medical procedures associated with a risk of bleeding (e.g. involving a needle or incision). The most frequent group that requires FP transfusions are patients admitted to an intensive care unit. These patients frequently have abnormal coagulation tests and also frequently require invasive medical procedures that can be associated with bleeding. While FP transfusions can improve abnormal coagulation test results, there is no evidence to suggest that prophylactic FP transfusions will reduce bleeding associated with medical procedures in patients with mild coagulation abnormalities. Additionally, it is known that important adverse complications occur with FP transfusions. The investigators will undertake a pilot randomized controlled trial in non-bleeding ICU patients who require an invasive medical procedure (central venous catheterization, chest tube, thoracocentesis, paracentesis, biopsy, fluid drainage) in 3 Canadian hospitals. Patients with an abnormal coagulation test (INR between 1.5 to 2.5) will receive a FP transfusion or no treatment prior to an invasive procedure. The primary outcome for this pilot study will be feasibility (the number of patients enrolled per month). Other important outcomes will include those that will be evaluated in the definitive trial including bleeding post procedure, red cell transfusions, adverse transfusion reactions, mortality and hospital length of stay. The objective of the study is to enrol 80 patients over 2 years in 3 Canadian hospitals.

Oral anticoagulants vitamin K antagonists (VKA) have been used for many years in the treatment of thromboembolic disorders, which are among the most costly diseases in terms of public health resources. According to the Agence française de sécurité sanitaire des produits de santé (AFSSAPS), it was estimated at about 900,000 the number of patients treated with VKA in 2008 (more than 1% of the French population). VKA are at the origin of many adverse effects, given their narrow therapeutic window. They are the cause of the death of approximately 5000 patients per year. The use of this therapy is a priority axis of reflection for the Haute Autorité de Santé. The interregion G4 (Nord Pas de Calais, Normandy, Picardy), with more than 9 million people, is particularly affected by this problem. University hospitals of our interregion, given their very substantial regional referral activity, are actually involved in managing VKA adverse side effects. Elderly population constitutes the majority of prescriptions. The main objective of this study is to compare INR of people older than 75 years measured by traditional method with those measured by capillary method with INRatio2 supply. The secondary objective is to show that this measure is not affected by the presence or absence of anti-phospholipid antibodies, probably very prevalent in the elderly, as well as to test the variability of INR measurement between different hospital.

Severe coagulopathy and operative bleeding are common in liver and multivisceral transplant recipients. This is related to reduced synthesis and function of clotting proteins in end-stage liver disease, thrombocytopaenia, thrombocytopathy, accelerated fibrinolysis, portal hypertension, inflammatory adhesions and intraoperative hemodilution. A pro-coagulant state is also a common finding in both groups, sometimes associated with fatal thromboembolism, and the balance between anti- and pro-coagulant effects is easily disrupted by intraoperative events. Use of point-of-care intraoperative viscoelastic testing, capable of discriminating between various potential causes of coagulopathy and of identifying some hypercoagulable states, is now routine in this setting. This has been shown to guide treatment faster and more reliably than standard laboratory screening tests. However, traditional viscoelastic tests based on a pin-and-cup arrangement are sensitive to technical error, movement and physical clot disruption, and the validity of measurements is highly dependent on operator training. A newer method (TEG® 6S) based on light reflection from a blood meniscus reduces scope for operator error but remains sensitive to movement. Measurement of ultrasonic resonance (or 'sonic estimation of elasticity via resonance [SEER] sonorheometry') using the Quantra® analyzer surgery appears to minimize these problems in studies performed in healthy volunteers, in spinal surgery and in both elective and urgent cardiac procedures. Pilot testing in the latter group suggests it may also differentiate qualitatively between fibrinogen and platelet deficiency, but the range of intrinsic coagulation disturbances in this context is limited. This study proposes to assess the validity of the Quantra® analyzer in a population with more extreme coagulopathy, including severe fibrinolysis, and recognized thrombophilic states.

Trauma continues to be the major killer of young Americans, mainly due to hemorrhage or brain injury. In trauma centers, up to a quarter of these severely injured patients arrive with a coagulopathy and thereby experience an increased risk of death, despite the current standard of medical and surgical management. The PI for this grant proposal is a fellowship-trained trauma surgeon who works full-time at Grady Memorial Hospital (GMH), the only Level I Trauma Center in Atlanta. It is only one of four Level 1 trauma centers for the entire state of Georgia. This research is a direct extension of the retrospective research the PI has previously published. Her retrospective research discovered a previously undescribed form of coagulopathy, early trauma induced coagulopathy (ETIC), which cannot be explained by present paradigms. Two civilian trauma articles as well as military data from the Iraq war have substantiated the occurrence of ETIC, but no prospective literature has defined it or its kinetics. More importantly, the results from these studies represent a new paradigm shift, in which ETIC appears to be a primary dysfunction which is independently associated with death. Therefore, its early identification and correction is crucial for our mechanistic understanding, and ultimately, our choice of interventions and improved survival. GMH is a high-volume trauma center that sees patients with a variety of injury mechanisms, and, therefore, is the perfect setting to confirm ETIC. First, the project will confirm the prevalence of ETIC with an observational prospective cohort of injured patients. Data on the coagulation system and risk factors, both known and suspected, of all patients will be collected upon patient arrival as well as patient outcome with all identifying information protected. This is the first prospective research project that will allow simultaneous control of confounders associated with outcome and thereby scientifically validate the occurrence of ETIC. One unique component of our data collection is a focus on the timing of events as they relate to the development and consequences of coagulopathy, to account for the dynamic process. At the completion of data collection, a matched cohort of ETIC and non-ETIC blood samples will be tested for coagulation factors to provide insight into ETIC's pathophysiology. In the short term, our conclusions will assist us in our approach to resuscitation of the bleeding trauma patient as some trauma centers have already started to change protocols based on our present incomplete understanding of trauma-induced coagulopathy. In addition, the coagulation system data collected in this study will lead to pathophysiological answers and to more refined hypotheses for future research at a coagulation system level. Ultimately an understanding of ETIC will lead to a more effective, tailored treatment. Our main study hypothesis is that post-trauma coagulopathy is a primary dysfunction that occurs early after a traumatic event in up to 25% of all trauma patients triaged to Trauma Center care.

The main purpose of this study is to analyse the on-going coagulation process after aSAH. For investigation the investigators use the rotational thromboelastometry (ROTEM) which is a point-of-care test using a variety of activators to provide a targeted and a dynamic analysis of coagulation cascade. This is a prospective, observational clinical study done in 16 aSAH patients treated in Tampere University Hospital intensive care unit and 16 control patients (elective craniotomy due to non-ruptured intracranial aneurysm.

This study is conducted in the United States of America (USA). Tha aim of this study is bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).

While a number of factors are known to be associated with the development of trauma induced coagulopathy (TIC), inflammation, and multi-organ failure, we currently cannot predict which patients are at risk for developing these life threatening conditions with any certainty. In this prospective observational study, we will investigate the many factors that contribute to the development of trauma induced coagulopathy, post injury inflammation and the development of organ dysfunction in order to develop a multi scale computational algorithm of clinical prediction. Using a convenience sample technique, demographic data, physiologic data, blood samples and clinical variables will be collected over 5 days following traumatic injury. A computational model will be used to predict the development of TIC and multi-organ failure.

This study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests in cardiac surgery patients. In addition the association of Quantra-derived parameters with select platelet function tests will be investigated.

This study aims to investigates the role of gestational age on the prevalence of coagulation factors and components of the complement system in preterm- (≤32+0 weeks) and term neonates (≥37+0 weeks) and their role for the development of brain hemorrhage.