6 Clinical Trials for Various Conditions
Background: Rotational thromboelastometry (ROTEM) has been used widely in liver transplantation for coagulation management. However, a TRUE-NATEM (TRUE-Non-Activated Rotational Thromboelastometry) reference value has never been established. A TRUE-NATEM value is of clinical significance since no coagulation activators or reagents will be added to the blood sample for analysis. Therefore, the result will reflect the true coagulation profile of the patient. Methods: Non-citrated whole blood will be used for analysis. Blood will be drawn from the patient and transferred into a plastic reagent cup that has no reagent. Test will be performed within 4 minutes of blood draw to avoid activation of coagulation. Primary outcome measure will be clotting time (CT), clot formation time (CFT) and maximum clot firmness (MCF). The specific aims of the study are to establish a TRUE-NATEM reference value using Rotational Thromboelastometry (ROTEM®) in patients undergoing liver transplantation. Our hypothesis is that clotting time (CT), clot formation time (CFT) is prolonged and maximum clot firmness (MCF) decreased compared to healthy volunteers in patient undergoing liver transplantation due to synthetic coagulation factor deficiency.
This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events.
The aim of this study is to evaluate the impact of a rotational thromboelastometry (ROTEM®)-based transfusion protocol during postpartum hemorrhage (PPH) after vaginal or cesarean delivery. Maternal transfusion requirement, quantitative blood loss (QBL), need for intensive care unit (ICU) admission, and length of hospital stay will be evaluated. The utilization of ROTEM® for transfusion management will identify patients who develop early coagulation changes such as hypofibrinogenemia or disseminated intravascular coagulation. Our hypothesis is that earlier identification and directed therapy of such coagulation changes will lower overall transfusion requirement (packed red blood cells, fresh frozen plasma, fibrinogen concentrate, cryoprecipitate, or other product), reduce the need for ICU admission, and shorten length of hospital stay. A cost analysis will be performed.
This is an interventional pilot study of 40 burn inpatients. Specific aims of the proposed pilot study are to use bedside blood analysis with rotational thromboelastometry (ROTEM) in severe burn patients to provide preliminary information on the nature of coagulation abnormalities and compare subject ROTEM coagulation profiles within 24 hours of burn injury (day 1) and on days 2, 3, 5, 7, 14 and 21 after burn injury.
Total hip arthroplasty (THA) is associated with blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis or by stopping naturally occurring clot resolution. TXA is employed currently based on a surgeon's preference. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on blood loss in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during THA. All patients, whether they receive TXA or normal saline, will not be at risk, as at this time no data exists to determine which approach is safer or more effective. This is the first study to compare TXA vs. placebo in a double-blinded, randomized controlled trial.
Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are antifibrinolytic agents routinely administered in children undergoing different surgeries associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries). Although there is a growing literature regarding the pharmacokinetic characteristics of these drugs in children, the plasmatic concentration required to completely inhibit fibrinolysis remains to be determined. In this in vitro study, the investigators will use an experimental model of fibrinolysis designed for rotational thromboelastometry (ROTEM®) to determine the minimal concentration inhibiting fibrinolysis for both TXA and EACA. In addition, this study will be used to create and validate a new experimental assay to measure fibrinolysis and the effect of antifibrinolytic agents.