Antithrombin Deficiency

This research aims to evaluate the effects of TAK-330 compared to standard four-factor prothrombin complex concentrate 4F-PCC in adults treated with Factor Xa inhibitors who need urgent surgery or invasive procedures. The study focuses on reversing anticoagulation caused by Factor Xa inhibitors and is a Phase 3, randomized, triple-blind trial sponsored by Takeda. Participants will be randomly assigned to receive either TAK-330 or the standard 4F-PCC. TAK-330 is given as a single intravenous infusion dose of 25 IUkg before surgery, with an optional additional 25 IUkg dose during surgery if needed, not exceeding a total of 50 IUkg or 5,000 IU. The standard 4F-PCC dose and infusion speed follow local protocols, with an additional dose allowed during surgery under the same maximum limits. These treatments are administered during hospitalization prior to surgery. During the study, participants will be hospitalized for the surgery and treatment administration, with assessments of hemostasis effectiveness at surgery end and 24 hours after treatment. Researchers will monitor blood product use, adverse events including thrombotic events, and participant survival up to 30 days after surgery. Follow-up will also include contact via telehealth or phone 30 days post-surgery to evaluate safety and outcomes. Total participation duration covers the hospital stay and the 30-day post-surgery monitoring period.

Researchers are investigating a new drug called BAY 3389934 to find a better way to treat people with sepsis-induced coagulopathy, a serious condition where an active immune response causes uncontrolled blood clotting, damaging blood vessels and organs. This early-phase study aims to learn about the safety, appropriate dose, and effects of BAY 3389934 in patients receiving treatment for this condition in intensive care units. The research is focused on monitoring medical problems, called adverse events, that occur during and after treatment. Participants will receive BAY 3389934 as a continuous intravenous infusion for up to 96 hours. They will be divided into two groups the first group will receive a low starting dose, and their response will be closely monitored to adjust the dose if needed. If there are no serious side effects, the second group will receive a higher dose. This dose escalation approach helps determine the best dose for future studies. During the approximately 28-day study, participants will have blood and urine samples taken, physical exams, vital signs checked, and heart health monitored with electrocardiograms. Researchers will track the number and severity of any treatment-emergent adverse events within about four days after starting the infusion. They will also measure blood clotting times over the first six days to assess effects on coagulation. The study is designed to carefully observe safety and drug effects while patients receive intensive care.

This research aims to evaluate the performance of the Perosphere ClotChek173 system, a hand-held, battery-operated blood coagulation device used at the point-of-care, in measuring whole blood clotting time WBCT in patients taking direct oral anticoagulants DOACs such as rivaroxaban or apixaban. The study focuses on characterizing how well this device can quantitatively assess clotting times in these patients compared to normal controls. Participants provide fresh whole blood samples taken at various times during the day to capture a range of clotting times rather than strict peak or trough measurements. The blood is loaded onto disposable cuvettes without biological reagents for testing with the Perosphere ClotChek173 device. This observational study collects these samples to analyze clotting times and device performance in relevant patient subgroups, including those with renal or hepatic impairments. During the study, participants will undergo venipuncture to provide non-citrated whole blood samples for the clotting time measurements. Researchers will evaluate the devices ability to distinguish between patients on rivaroxaban or apixaban and normal controls. Safety and patient history will be reviewed to ensure eligibility, and clotting times will be assessed on the day of sampling. The study is expected to run until June 2027, with participants involved in a single visit for sample collection and device evaluation.

Researchers are studying different dosages of tranexamic acid in adults undergoing elective cardiac surgery with cardiopulmonary bypass to understand how long the drug inhibits fibrinolysis, which helps prevent excessive bleeding. This trial aims to find the best dosage regimen by measuring clotting function and drug levels in the blood. The study is randomized and quadruple-masked to compare three dosing strategies and their impact on blood loss and related complications. Participants will be randomly assigned to one of three groups receiving tranexamic acid a 10 mgkg dose followed by a continuous infusion of 1 mgkg per hour until surgery ends, a single 20 mgkg dose, or a single 30 mgkg dose given before surgery starts. Blood samples will be collected at multiple time points during and after surgery to perform ClotPro viscoelastic testing and measure tranexamic acid levels. If clotting inhibition decreases early, an additional 10 mgkg dose is given. Throughout the study, researchers will collect detailed information including patient characteristics, surgery duration, anesthesia details, blood transfusions, bleeding amounts, and any adverse events. Postoperative care data such as mechanical ventilation duration, ICU and hospital stays, and mortality will also be tracked. The primary measurement is the duration of fibrinolysis inhibition as indicated by ClotPro results and its correlation with tranexamic acid blood levels. Secondary outcomes include bleeding, transfusion needs, seizures, thrombotic events, and length of recovery up to one year after surgery.

Researchers are evaluating how four different types of central venous catheters CVCs affect the bodys blood clotting system. CVCs are thin tubes placed in large veins to give medications, fluids, or take secure blood samples, but they can sometimes cause blood clots, leading to serious health issues. This randomized controlled trial aims to compare the impact on coagulation caused by these commonly used catheters to better understand clot formation after catheter insertion. Participants will be randomly assigned to receive one of four different two-lumen central venous catheters, each made of polyurethane but with different sizes or coatings, including antimicrobial and silver ion-embedded options. Blood samples will be taken twice from each catheter once immediately after insertion without flushing, and once after flushing with saline and discarding the initial blood. These samples will then be tested with rotational thromboelastometry ROTEM and other coagulation tests to compare clotting times and related markers between catheter types and within the overall group. During the study, participants will undergo catheter placement followed by blood sample collection at two specific times. The blood will be processed and analyzed shortly after collection to measure clotting times, clot strength, and various coagulation factors. The main outcome is the change in clotting time between the two samples. This information will help researchers identify how different catheters interact with blood clotting and could lead to safer catheter use and better prevention of clot-related complications. Participants will be monitored throughout the procedure and sample collection process, which is expected to last a short time after catheter insertion.

Researchers are investigating how the blood clotting and platelet function change in patients with end-stage heart failure who receive mechanical circulatory support devices such as percutaneous microaxial pumps Impella, extracorporeal membrane oxygenators ECMO, or Ventricular Assist Devices VAD. The study aims to understand how these devices interact with the bloods clotting system and antithrombotic drugs to identify causes of clotting or bleeding complications and potential treatment targets. The study uses two innovative tests to evaluate platelet function the Platelet Activity State PAS assay and the Thrombin Generation Test TGT. These tests are performed at several points before device implantation to establish baseline values, early after implantation during hospital stay, throughout long-term follow-up, and when complications or therapy changes occur. Alongside these tests, standard blood parameters related to coagulation and hemolysis are measured, and device function data such as pump speed and power use are recorded. Participants are monitored for up to 24 months with evaluations at 1, 3, 6, 12, 18, and 24 months after device implantation, as well as when any adverse events happen. Researchers track changes in platelet activity, coagulation markers, device parameters, and antithrombotic therapies. The study focuses on understanding how these factors relate to post-implant complications to improve patient care and device management.

Snakebites from Bothrops species are a significant health concern in French Guiana and Martinique, with envenomation causing severe local and systemic effects. This research aims to explore the role of plasma Willebrand factor activity and endothelial activation in patients bitten by Bothrops snakes in these regions. The study investigates how venom from different Bothrops species affects blood clotting and inflammation, potentially explaining distinct clinical outcomes like bleeding or thrombosis. Understanding these mechanisms could lead to more personalized treatment approaches for snakebite victims. Participants include patients with confirmed Bothrops snakebites from French Guiana and Martinique, divided into two groups of 15 each. Blood samples will be collected for research analysis alongside routine care, focusing on Willebrand factor activity before and after anti-venom treatment. The study does not involve new treatments but monitors biological markers related to coagulation and endothelial function to understand venom effects better. During the study, patients will have additional blood drawn at hospital admission and on days 1 and 8 to measure plasma Willebrand factor activity. Researchers will assess coagulation status and related biological changes while recording clinical signs of envenomation. The study is observational, with no experimental interventions, and participants are followed up during their hospital stay to gather data on venom effects and recovery. Total participation duration varies depending on clinical course but includes key blood sampling points within the first week.

Researchers are evaluating the incidence of thrombotic events and thromboembolic events in patients with congenital antithrombin deficiency who receive Atenativ during surgery or childbirth. This phase 3, open-label study aims to assess the safety, efficacy, and pharmacokinetics of Atenativ in these patients. The study includes both surgical patients and pregnant patients undergoing delivery, addressing an important need in managing this rare blood disorder during high-risk procedures. Participants receive Atenativ, an antithrombin concentrate, in two phases. In the pharmacokinetics PK phase, a single intravenous dose of 60 IUkg is given to analyze how the drug behaves in the body. In the treatment phase, patients receive an initial intravenous loading dose followed by maintenance doses every 24 hours for about 2 to 7 days if undergoing surgery, or about 5 days if giving birth by caesarean section or delivery. Throughout the study, participants undergo regular blood tests to monitor coagulation parameters and drug levels up to 14 days after infusion, as well as safety monitoring for adverse events up to 30 days after treatment starts. Researchers closely track thrombotic event incidence up to 30 days post-treatment. Participants are involved in scheduled visits for drug administration, blood sampling, and clinical assessments to ensure thorough evaluation of Atenativs effects and safety during and after treatment.

Researchers are studying patients of all ages undergoing complex heart surgeries that use cardiopulmonary bypass CPB to better understand blood clotting problems that can happen during and after surgery. The study focuses on the role of immune cells called monocytes and substances in the blood like GABA and inflammatory cytokines, which may contribute to abnormal clot formation and related complications. This observational research aims to explore these biological factors to improve future care for patients at risk of blood clots during heart surgery. The study uses discarded blood samples taken during routine clinical testing before, during, and after cardiac surgery to analyze monocyte activation and levels of serum GABA and pro-inflammatory cytokines. By collecting data over the course of surgery and recovery, the research team hopes to find links between immune activity and clotting risks. The study does not involve experimental treatments but focuses on detailed laboratory analyses of blood samples. Participants provide blood samples during their surgical care, with no additional interventions beyond routine clinical procedures. Researchers will monitor monocyte activation status and blood markers related to inflammation and clotting for about one year following surgery. The main outcomes measured include monocyte activation, serum GABA, pro-inflammatory cytokines, and clinical thrombosis events. This allows for a comprehensive assessment of factors involved in clotting complications after complex cardiac surgery with CPB.

This research aims to identify if a new biomarker related to blood clot risk, called endothelial derived extracellular vesicles, along with changes in blood clotting time, can predict which patients with a Transient Ischemic Attack TIA are most likely to have a stroke. The study focuses on TIA patients, as over 25% of ischemic stroke cases occur in people who previously had a TIA. Stroke is a leading cause of disability, and preventing strokes in high-risk patients is a national health priority. The study will follow 300 participants over 12 months, divided into four groups healthy individuals without stroke or TIA history people referred to TIA clinics but found not to have TIA patients confirmed with TIA who did not have a stroke within 12 months and patients with TIA who did have a stroke within 12 months. Researchers will monitor and compare changes in extracellular vesicle levels and prothrombin time in these groups to assess stroke risk. Participants will undergo blood tests to measure the biomarker and clotting time, with follow-up over three years to observe changes. The study collects clinical information and imaging results to confirm stroke or TIA diagnosis. Researchers will also track patient diet status and medication use. The main outcomes are changes in the extracellular vesicles and prothrombin time, which may help identify those at highest risk for stroke after TIA.