View clinical trials related to Hemostatic Disorders.
Filter by:The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery.
Understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also look into the consequences of switching treatment in QoL (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.
A wide variety of individuals are at risk for bleeding, but even though bleeding symptoms are common it is difficult to compare different people's symptoms. Recent research has found that carefully designed surveys can be used to calculate a bleeding score that is useful for diagnosing bleeding disorders, but normal individuals have not been specifically studied in large numbers with a comprehensive survey. Whether factors like race, ethnicity, age, sex, aspirin use, and previous trauma and surgery influence bleeding scores is also unknown. The primary goal of this study is to use a comprehensive computerized questionnaire to record the bleeding symptoms of normal individuals and then assess the range and severity of bleeding symptoms in this normal population. Secondary goals include determining whether race, ethnicity, age, sex, aspirin use, and previous trauma and surgery correlate with bleeding symptoms.
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 trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.
This study is conducted in the United States of America (USA). The aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in patients with congenital haemophilia with inhibitors to factors VIII and IX. We are further investigating how bleeding episodes affect the quality of life of the patient and their family or caregivers.
The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.
This study was conducted in Africa, Europe, the Middle-East and South America. The primary objective of this registry was to observe the use of single dose and multi-dose use of activated recombinant human factor VII and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.
The high percentage of failure using available non-surgical options to treat menorrhagia in women with bleeding disorders shows a continuing need for innovative treatments. This has led to development of this protocol in order to make available tranexamic acid as a potentially effective menorrhagia therapy option in women with an underlying bleeding disorder. We anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in bleeding disorder patients.
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.