View clinical trials related to Hemostatic Disorders.
Filter by:Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option. This phase II clinical trial evaluates the use of 4-Factor PCC in addition to standard resuscitation methods compared to standard resuscitation methods alone in patients with TIC. Patients will be randomized at a 1:1 ratio. The primary endpoint of this trial will be 30 day mortality.
Patients with severe subarachnoid hemorrhage (SAH) may present platelet and coagulation dysfunctions immediately after the stroke on admission at the hospital, and persisting up to 3-4 weeks after the onset. This study aimed to investigate the platelet function as assessed by impedance agregometry (ROTEM Platelet) and platelet adhesion (PFA), and the coagulation profile as assessed by ROTEM, over three evolutive times.
Postpartum hemorrhage (PPH) is one of the leading causes of maternal deaths. Its prognosis is directly influenced by the early diagnosis and treatment of the associated coagulopathy. In this context, fibrinogen concentration is the best predictor of a severe PPH. The medical interest of thromboelastography/elastometry to early detect and guide the rapid correction of coagulopathy in PPH is regularly discussed. The principal aim of this study is to evaluate the performance of a new hemostasis point of care device (thromboelastography - TEG ®6S) for the diagnosis of coagulopathy during PPH. A secondary aim will be to determine the normal values of TEG6S at the end of a normal pregnancy.
Introduction. The development of joint hemorrhages in patients with congenital coagulopathies favor the development of an intra-articular, degenerative and progressive lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of hemophilic arthropathy and is related to the development of disability and a worse quality of life. Objective. Observe the characteristics of pain, coping models and the perception of quality of life in patients with congenital coagulopathies. Study design. Observational, cross-sectional and multi-center study. Method. 80 patients with congenital coagulopathies (hemophilia A and B, and von Willebrand's disease), of legal age, will be included in the study. Patients will be recruited in six centers, from different regions of Spain. The study variables and measurement instruments used will be: pain perception (numerical pain scale, Tampa Scale of kinesiophobia and Pain Catastrophizing Scale); perception of quality of life (Short Form -36 questionnaires); anxiety (State-Trait Anxiety Questionnaire); coping strategies (Coping Strategy Questionnaire); and disease perception (Illness behaviour questionnaire and Revised Illness Perception Questionnaire). A descriptive statistical analysis of the dependent and independent variables will be carried out. In the same way, the correlations between the variables and the characteristics of the subjects will be analyzed according to age, the type of coagulopathy and the degree of sequelae. Expected results. Observe the characteristics of pain, its coping models and its implication in the quality of life in patients with congenital coagulopathies, and evaluate the independent variables related to the perception of pain.
Early identification of trauma patients in need for Damage Control Resuscitation (DCR) has potential to be beneficial for general emergency units that are not expected to be ready for this rare situation 24 hours per day, 7 days per week. It could also be useful for high performing trauma centers to identify such patients earlier and be able to provide earlier adequate treatment. By contrast, initiation of DCR in patients who do not require this aggressive therapy may negatively affect their survival. An early identification of patients who do not require DCR would probably be beneficial (impact on cost-effectiveness and on patients' survival). The evidence of the Trauma Induced Coagulopathy Clinical Score (TICCS) accuracy has been evaluated in several studies but the potential effect of its use on patient outcomes needs to be evaluated. There has never been any evaluation of the impact of a prehospital discrimination of trauma patients with or without the need for DCR. The primary objective of this study is to evaluate the impact on mortality of a prehospital discrimination between trauma patients with or without a potential need for DCR. Secondary objectives include evaluation of the feasibility of such discrimination and its impact on cost-effectiveness. We hypothesize that the information will lead to improved quality of care with reduced mortality and morbidity.
The investigators have developed an optical system that measures the coagulation status of patients in vivo in a non-invasive manner. The system is based on a small optical sensor that emits coherent light into the skin and collects the reflected light from the red blood cells in the blood vessels in the skin under the sensor. The sensor is placed on the fingertip, and during a brief period of occlusion of blood flow by a small pneumatic cuff, red cell movement becomes Brownian in nature and is thereby affected by the viscosity of the blood. In patients who have a bleeding tendency, red blood cell movement will be faster, while in patients with a hypercoagulable state the red cell movement will be slower. Treatment with anticoagulant medications is expected to affect the movement of the red blood cells and these changes can be detected by the sensor. The investigators plan to test the device in normal subjects and in subjects taking Coumadin, direct oral anticoagulants, antiplatelet drugs and heparin-based medications. The investigators will determine whether anticoagulants affect the noninvasive measurement and compare the results with standard laboratory tests of coagulation.
Prospective observational study in which FXIII levels and coagulation tests and cicatrization are measured during the 30 days after the thermal trauma.
The study aims to investigate the impact of preeclampsia on hemostasis.
Recently it has been acknowledged that cirrhotic patients present with "rebalanced hemostasis" that results from decreased levels of both pro-coagulant and anti-coagulant factors, that is not well reflected by conventional coagulation tests (CCTs). Thromboelastography (TEG) might be a more accurate tool in these patients. Numerous guidelines on the management of the cirrhotic patient undergoing invasive procedures have been published but most of them are not evidence based. Current literature, although conflicting, is leaning towards a restrictive approach to prophylactic correction of coagulopathy when performing invasive procedures in cirrhotic patients. The investigators suspect that common practice is more liberal . Considering the well-known adverse effects of blood product administration, the aim of the study is to re-evaluate the clinical management of cirrhotic patients undergoing invasive procedures. Study objectives: asserting whether the use of blood products prior to invasive procedures in cirrhotic coagulopathic patients can be reduced using TEG to evaluate coagulopathy in place of CCTs, evaluating the rate of complications due to blood product use, and checking how well CCT results correlate with TEG results in these patients. This will be a prospective pre/post TEG protocol implementation study which will include two prospective surveys with a 1:1 ratio. Survey 1: prophylactic administration of FFP/PLT prior to minor invasive procedures will be based on CCTs and physicians' clinical judgement. Survey 2: management will be based on a new TEG protocol. The investigators will include cirrhotic patients with coagulopathy who are candidates for an invasive procedure. Subject will be provided with sufficient time to reach a rational, informed decision regarding participation in the study. Data will be collected from the computer based medical record systems, the patient file and directly from the caring physician and will include a thorough medical history and conventional blood tests, including a TEG test. All subjects will be managed according to standard of care. Primary endpoint: amount of blood product (fresh frozen plasma/platelets) units transfused in preparation for the invasive procedures. Secondary endpoints: bleeding complications, transfusion related side effects, 90 day survival and other complications. This will be a prospective (pre/post) study. The calculated sample size needed is 120 subjects, 60 in each group.
Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and mortality. Clot formation and clot stability are important factors in coagulation and hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role in bleeding after cardiac surgery. The primary objective of this study is to evaluate the relationship between point-of-care determined platelet function and thrombin generation and postoperative bleeding in infants and young children undergoing cardiac surgery with cardiopulmonary bypass adjusting for clinically important confounding factors.