Active clinical trials for "Hemostatic Disorders"

Information on the management of casualties from the ongoing conflicts in Afghanistan and Iraq has brought in to question the traditional approach to blood transfusion in hemorrhaging patients. Present recommendations for when to transfuse plasma products is when coagulation tests become abnormal. The proposed trial will investigate whether the more aggressive plasma transfusion strategies as advocated from researchers based on the Central Asian conflicts is valid. Since a study to determine the full impact of an altered plasma transfusion practice would require thousands of patients, a feasibility trial is appropriate and is being proposed. The hypotheses are thus: Primary Hypothesis- A multicentre trial that investigates the earlier use of plasma in patients with hemorrhagic shock going for emergency surgery will be feasible. Secondary Hypotheses- The early use of a universal donor blood plasma (AB+ plasma) in patients with shock due to blood loss (i.e. hemorrhagic) going for emergency surgery will reduce overall exposure to the total number of blood donor products (so-called allogeneic blood exposure). A reduction in allogeneic blood exposure would then reduce the total number of blood transfusion-related complications. The early use of this plasma product is safe and will not increase the incidence of blood clotting or other transfusion-related complications.

This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.

With the advent of measures to try to decrease the incidence of transfusion-related acute lung injury (TRALI), the Blood Bank industry is attempting to avoid collection of plasma from female donors who have been pregnant in order to reduce the transfusion of plasma that may contain HLA antibodies. This has led to a decrease in the number of donors available for the production of fresh frozen plasma (FFP). Per Blood Bank regulatory standards in the United States, FFP must be frozen within 8 hours of collection. Plasma that is frozen within 24 hours of collection is called FP24, and it is produced when whole blood cannot be processed within the 8-hour time period for the generation of FFP. Studies of coagulation factors in FFP and FP24 have shown that coagulation factor activities are adequate to maintain hemostasis in both products. Many hospitals are using FFP and FP24 interchangeably in adults, and occasional hospitals are using these products interchangeably in neonates. However, studies concerning the use of FP24 in neonates have not been performed. The investigators propose a single center prospective pilot study comparing the clinical efficacy of FFP vs. FP24 in 50 nonsurgical neonates and babies up to age 6 months requiring plasma for an International Normalization Ratio (INR) of 1.5 or more. This protocol describes a pilot study to compare the use of FFP with FP24 in nonsurgical neonates. Use of plasma in these cases is mostly for patients with perinatal hypoxia or necrotizing enterocolitis and an INR of 1.5 or more. Transfusion of plasma (10 to 15 ml/kg) is performed for these patients approximately every 8, 12, or 24 hours, as deemed indicated by the patient's clinicians, and monitored with prothrombin time (PT), partial thromboplastin time (PTT), and INR.

Warfarin (also called Coumadin®) is an anticoagulant drug (blood thinner) given to patients to help prevent blood clots from forming or to help prevent the growth of an existing blood clot. The purpose of this study is to collect information on a possible method used to determine the best warfarin dose for people before they start warfarin. This study will focus on finding out if a person's stable dose can be better predicted by using a new approach (called "pharmacogenetic-guided dosing") compared to the current warfarin dosing method. The pharmacogenetic-guided dosing method (the new warfarin dosing method) will use a person's specific health and genetic information to calculate a patient's warfarin dose at the beginning of warfarin treatment. The hope is that through this research, we may someday be able to use an individual's genetic information to guide the selection of their specific warfarin dose at the beginning of treatment, leading to precise warfarin dosing and less need for the current trial and error process.

Main objective: Determine whether by introducing thromboelastograph, the investigators reduced the number of packed red cells received by each patient (median) compared to the usual protocol, in which the indication for transfusion is based on laboratory tests: Prothrombin time, time activated partial thromboplastin time, thrombin, reptilase, fibrinogen and platelet contage. Design: Prospective randomized controlled trial and single blinded. Disease or disorder under study: Study of coagulopathy in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). Primary endpoint: median transfusion of packed red blood cells per patient. Study population Male and female patients over 18 years undergoing cardiac surgery with cardiopulmonary bypass to bleed excessively. Duration of treatment: The coagulation monitoring methods tested are made from protamine administration to CEC output if a) the patient bleeds diffusely, or b) from arrival in the unit if not satisfied critics a) bleed excessively drains and until the patient stops bleeding (debit drains <a 150ml / h).

This study is to screen out the biomarkers and establish the model to predict coagulation dysfunction induced tigecycline

Trauma is the leading cause of death in young people. Trauma-induced coagulopathy (TIC) encompasses several aspects of traumatic bleeding. Monitoring of coagulopathy comprises use of Point-of-Care (POC) methods, such as thromboelastography (TEG) or Thromboelastometry (ROTEM) and conventional laboratory assays (platelet count, fibrinogen level, and PT or INR). POC tests are thought to have a better performance on mortality and bleeding control than conventional tests. The aim of this study is to compare POC and conventional assays with plasma consumption as a primary outcome and 28 days mortality as a secondary one.

Investigate the validity of Hemosense System in pediatric patients on anticoagulation therapy.

The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.

Liver resection is the treatment of choice in patients with primary or metastatic liver neoplasms, benign liver neoplasms and numerous biliary diseases. In these patients, in the postoperative period,several factors can induce a transient alteration of the synthesis hepatic coagulation factors such as size of the lesion liver, underlying liver disease (e.g. malignancy), pre-existing cirrhosis, duration of both surgery and vascular clamping, and blood loss. So far, some studies have shown that conventional coagulation tests indicate a hypocoagulable state which may lead to excessive transfusions of blood products or an increased risk of thromboembolic events related to delayed initiation of thromboprophylaxis in the postoperative period. In an attempt to optimizing the state of coagulation, recently there is increased interest for viscoelastic coagulation testing (thromboelastography and rotational thromboelastometry). The results of these studies have shown that these patients often have a hypercoagulable and non hypocoagulable profile as evidenced by conventional coagulation tests. the purpose of the study is to evaluate whether the combination of coagulation tests conventional systems and new thromboelastography can increase the quality of surveillance of the coagulation state after liver surgery, in order to optimize the management of postoperative blood coagulation of these patients.