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NCT07470385
The goal of this observational study is to learn how intravenous lipid emulsions may affect blood clotting function in hospitalized patients. The main question it aims to answer is: Does receiving intravenous lipid emulsions change blood clotting function in hospitalized patients? Inpatients who received intravenous lipid emulsions as part of their regular medical care during hospitalization will be included in this study. Information about their blood clotting function before and after lipid emulsion use will be collected from existing hospital records and compared with patients who did not receive lipid emulsions. This study will not change or add to the medical care patients receive.
NCT05156983
The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa inhibitors who require urgent surgery/invasive procedure. The participant will be assigned by chance to either TAK-330 or SOC 4F-PCC as part of standard treatment before surgery. Patients participating in this study will need to be hospitalized. They will also be contacted (via telehealth/phone call) 30 days after the surgery.
NCT03826043
The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200 cancer patients, about 5 times higher than in the general population. These events are of crucial importance, since nearly 10% of cancer patients died from thromboembolic events (EVT), making them the second leading cause of death in this population. In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% - 2% before 1990 to 4% since 1990. Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients. Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy. In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified. Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet aggregation (AGP) and / or direct oral anticoagulant (AOD). In this study, the investigator means by hypocoagulability any situation modifying the normal coagulation system.
NCT06517563
A single centre, open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin (UFH) and of VMX-C001 alone on the efficacy of Low Molecular Weight Heparin (LMWH) in healthy subjects conducted in two parts: UFH cohort: Subjects will be administered 2 single doses of 5000 IU UFH i.v. on Day 1 and Day 5, oral doses of the DOAC Rivaroxaban once daily from Day 2 until the morning of Day 5, and one single dose of 170 mg VMX-C001 i.v. on Day 5. LMWH cohort: Subjects will be administered 2 single doses of 40 mg Enoxaparin s.c. on Day 1 and Day 4, and one single dose of 170 mg VMX-C001 i.v. on Day 4.
NCT06403163
the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage. The aim is to allow different modelling and analysis related to emergency transfusion.
NCT05484830
Acute aortic dissection (AAD) involving the ascending aorta (Stanford classification type A) remains a life-threatening disease. Excessive perioperative bleeding requiring massive transfusion of allogeneic blood products, and surgical reexploration remain major challenges in these patients. Previous research has indicated that patients with AAD show pronounced haemostatic alterations prior to surgery which are aggravated during major aortic surgery with cardiopulmonary bypass and hypothermia full heparinization. Intensified anticoagulation management guided by heparin dose response (HDR) calculation, and repeated measurement of heparin concentration may be more effective than standard empiric weight-based heparin and protamine management monitored by activated clotting time (ACT) measurements to suppress thrombin generation during surgery for AAD. This randomized controlled clinical trial compares the impact of two recommended anticoagulation management strategies during surgery for AAD including deep hypothermia on activation of coagulation: Heparin/protamine-management based on HDR-titration by means of HMS Plus® versus current institutional standard (HDR- versus ACT-approach). Primary endpoint is thrombin generation as measured by early postoperative prothrombin fragment 1+2 (F1+2). Secondary endpoints are other markers of coagulation and fibrinolysis as well as clinical outcome.
NCT00178594
The objective of this study will be to assess the coagulation system in-vitro in a variety of bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay.
NCT03136510
Apixaban is a potent, oral, selective reversible direct inhibitor of factor Xa with a favorable efficacy and safety profile in the prevention of non valvular (NV) atrial fibrillation (AF). It has been shown, including by our group, that D-dimers levels (molecular marker of coagulation activity) are predictive of the events (including mortality) in patient with AF independently of the antithrombotic treatment. The aim of the study is to evaluate the changes in plasma levels of biomarkers of coagulation activation: D-dimers, prothrombin fragments F1+2, von Willebrand factor (vWF) and thrombin-antithrombin complexes (TAT) in response to apixaban treatment in patients with NVAF.
NCT04107818
The purpose of the study is to describe the differences and interchangeability in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.
NCT03734588
SPK-8016 is in development for the treatment of patients with inhibitors to FVIII. This Phase 1/2, open-label, non-randomized, dose-finding study to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with severe hemophilia A and no measurable inhibitor against FVIII.
NCT01221389
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.
NCT05698160
This study is to screen out the biomarkers and establish the model to predict coagulation dysfunction induced tigecycline
NCT04499274
Ondansetron may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of ondansetron. The investigators therefore will perform the present study to measure the effect of ondansestron on the blood coagulation pathway according to the drug concentration level using a thromboelastography test.
NCT03634215
Coagulation factor XIII (FXIII), a plasma transglutaminase, is known as the final enzyme of the coagulation cascade, responsible for a cross-linking of fibrin to strengthen blood clot. It also minimizes fibrin degradation by its cross-linking it with alfa2-antiplasmin molecules. It has been found that similar to plasma fibrinogen level, FXIII activity can be reduced in the early phase of severe trauma. Therefore, its immediate substitution is of potential therapeutic interest in trauma-induced coagulopathy. However, unlike plasma fibrinogen level evaluation, measurement of the FXIII activity is not routinely available. Therefore, targeted substitution of FXIII is practically impossible. The plasma fibrinogen level is routinely measured in severe trauma patients. Based on pathophysiologic assumptions and a limited number of published data we hypothesize that the FXIII activity correlates with fibrinogen level. In such case, indirect FXIII activity prediction by fibrinogen level measurement would be a convenient approach to enable FXIII targeted substitution. Therefore we decided to perform a prospective observational clinical trial to determine whether the low plasma fibrinogen level in severe trauma correlates with decreased FXIII activity.
NCT04762576
Coagulopathy, bleeding, and transfusion are common in cardiac surgical patients. Our collaborator has developed a novel point of care device that can be used to assess thrombin generation in real-time in cardiac surgical patients. The investigators will measure thrombin generation using our novel device and compare it to standard methods, while examining the association of thrombin parameters with bleeding and other clinical outcomes.
NCT03391622
Cardiovascular diseases are the most common cause of death in the western world. Myocardial infarction pathogenesis usually involves the development of an atherosclerotic plaque and thrombus. Past research has shown a correlation between thrombin generation values and ischemic heart disease, however, to our knowledge no investigation has been done into the correlation of thrombin generation and cardiac catheterization results in ischemic heart disease patients. In the current research the investigator will investigate the correlation of thrombin generation values using calibrated automated thrombogram and cardiac catheterization results in active ischemic heart disease patients.
NCT05272475
Chamomile may possess anticoagulant effects based on the presence of coumarin-like compounds within the flower. This randomized complete crossover study will investigate the impact of chamomile ingestion acutely on coagulation.
NCT05353673
Randomized, open-label, multicenter study to compare the efficacy and safety of combination of Sitagliptin and danazol versus danazol for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).
NCT04474249
The study will follow COVID-19 patients who required intensive care after 3-6 months and one year after discharge from the ICU with functional level as well as organ function to assess recovery after COVID-19. Blood and urine will be collected for biobanking.
NCT04762550
This is a prospective observational study of 100 patients undergoing liver transplantation at a single centre. Thrombin generation and kinetics will be assessed using a novel point-of-care device, and compared to conventional measures of hemostasis as well as viscoelastic tests to pinpoint specific coagulation deficits and identify potential therapeutic targets. The clinical course of patients will be followed for major bleeding and transfusion outcomes.