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Hemostatic Disorders clinical trials

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NCT ID: NCT04580563 Completed - Septic Shock Clinical Trials

Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study

PlasmaFaisa
Start date: October 22, 2020
Phase: N/A
Study type: Interventional

No randomized controlled trial (RCT) has investigated the effect of prophylactic fresh frozen plasma (FFP) transfusion in septic or critically ill patients with coagulation abnormalities. The last Surviving Sepsis Campaign therefore suggests with a very low quality of evidence "against the use of fresh frozen plasma during septic shock to correct clotting abnormalities in the absence of bleeding or planned invasive procedures". However, expert opinion highlights that FFP should be transfused "when there is a documented deficiency of coagulation factors (increased prothrombin time, international normalized ratio - INR, or partial thromboplastin time) and the presence of active bleeding or before surgical or invasive procedures". Disseminated intravascular coagulation (DIC) is responsible for such a severe deficiency of coagulation factors. Supplementing the intense deficit of coagulation factors with plasma containing non-activated coagulation factors is therefore a rational therapy in DIC patients. OctaplasLG® is a donor plasma product, with unique features compared to standard fresh frozen plasma: standardized concentrations of natural pro-/anti-coagulation factors; a standardized volume; pathogen free. OctaplasLG® should reduce the "inflammatory hit" on the endothelium, including the glycocalyx, by having standardized levels of coagulation proteins, which can give more sustainable support to the endothelial regeneration as compared to standard fresh frozen plasma.

NCT ID: NCT04553172 Completed - Bleeding Diathesis Clinical Trials

Vascular Abnormalities and Bleeding Diathesis

Start date: March 1, 2016
Phase:
Study type: Observational

Inherited bleeding disorders (IBD) consist of a heterogeneous group of diseases including coagulation and/or platelets defects and more rarely vascular dysfunctions. A family of four patients suffering from unexplained excessive bleeding has been followed clinically in France for many years. Recently, whole exome sequencing (WES) of DNA allowed the identification of a heterozygous genetic variant which segregated to family members with bleeding diathesis. The aim of the study was to better characterize the phenotype by studying VWF and platelets in affected family members ultimately contributing to the pathogenesis of a bleeding diathesis.

NCT ID: NCT04520282 Completed - Snake Bites Clinical Trials

Hemostatic Variables In Snakebite Study

HISS
Start date: March 15, 2022
Phase:
Study type: Observational

Background Novelty The global assays of coagulation, namely the viscoelastometric tests and clot waveform has never been studied in detail before in snakebite victims. The pathophysiology of VICC including specific factor deficiencies and serial trend in blood cell indices amongst various hematotoxic snakebite in the region is not known. No Indian study to date has systematically examined the changes in early laboratory tests results in envenomed and non envenomed snakebite victims.

NCT ID: NCT04517461 Completed - Clinical trials for Head and Neck Cancer

Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery

MVL-COAG
Start date: September 15, 2020
Phase:
Study type: Observational

For patients with large head and neck tumors the recommended treatment, in many cases, is a combination of extensive surgery and postoperative radiotherapy. The surgical procedure involves resection of the tumor and reconstruction with a so called microvascular free flap, i.e. tissue transferred from for instance the arm or leg to the resection site. Complications of this complex procedure include, but are not limited to, bleeding and blood cloths (thrombosis) in the transferred tissue (free flap), which can cause very serious complications including need for further surgery and loss of the flap. Routine blood tests can measure parts of the system that regulates bleeding and the forming of blood clots, the so called coagulation system, but these tests don't cover the whole system. There are however more advanced instruments, such as ROTEM, rotational thromboelastometry, which provide a more global view of the hemostatic potential of whole blood. ROTEM is one of few more advanced assays that can be analyzed in emergency situations in major hospitals. Other more advanced coagulation assays are thrombin generation and measurements of specific coagulation factors, several of which are vitamin K dependent. Vitamin K is essential in the coagulation system and also involved in many other physiological processes. Deficiency of this vitamin is common, but not well studied in patients undergoing head an neck free flap surgery. The investigators plan to study ROTEM and other above mentioned coagulation parameters in patients undergoing major head and neck surgery including microvascular free flap reconstruction to assess if these parameters can help predict patients at risk for bleeding or flap thrombosis. Further on this could hopefully enable prevention of complications and improve treatment of coagulation complications that still occur.

NCT ID: NCT04507230 Completed - Coagulopathy Clinical Trials

COVID-19 Associated Coagulopathy in Egypt

Start date: August 7, 2020
Phase:
Study type: Observational

Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most commonly observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation (DIC) compared to 0.6% of survivors.

NCT ID: NCT04505475 Completed - Surgery Clinical Trials

Oral Surgery in Patients Taking Direct Oral Anticoagulants

OSDOA
Start date: May 25, 2015
Phase:
Study type: Observational

This study evaluates the incidence of postoperative bleeding after oral surgical procedures in patients taking direct oral anticoagulants and in patients taking vitamin K antagonists.

NCT ID: NCT04499612 Completed - Thromboembolism Clinical Trials

Influence of Cardiac Implantable Electronic Devices on the Hemostatic System

Start date: March 1, 2020
Phase:
Study type: Observational

The hemostasis system is one of the many biological systems of the human body, designed to preserve the liquid state of blood and prevent its loss during vascular injuries. The ideal balance between its coagulant and anticoagulant components never occurs. In various diseases and pathological conditions, the balance of the hemostasis system may be disturbed. Shifts towards hypercoagulability lead to the development of hemorrhagic complications, opposite shifts lead to the development of thrombotic complications. Patients with cardiac implantable electronic devices (CIED) are not rare and unique, today doctors meet with them every day. Its more than 1.5 million CIED's implanted every year. Before surgery these patients are standard cardiology department patients with chronic heart failure (CHF), which develops due to the presence of arrhythmias, coronary heart disease, hypertension, congenital heart disease, myocardial infarction, myocarditis or other diseases and conditions. CHF is the most common, severe and unfavorable prognostic complication of these diseases. With CHF, the balance of the hemostasis system shifts towards hypercoagulation. Patients with CHF have an increased risk of arterial and venous thrombosis, pulmonary embolism, myocardial infarction, stroke, numerous brady- and tachyarrhythmias and other complications. After CIED implantation, bradyarrhythmia is eliminated, as one of the parts in the pathogenesis of CHF. Patients, especially those with severe symptoms, improve their condition in the early postoperative period. In the long-term period, pacing, on the contrary, may contribute to the progression of CHF. The wrong choice of pacing mode or the place of electrode implantation can lead to desynchronization of the heart chambers, myocardial remodeling and left ventricular dysfunction. Uncertainty is also observed in relation to the hemostasis system after CIED implantation. On the one hand, correction of bradyarrhythmia and CHF should provide patients with a shift towards hypocoagulability by normalizing the heart rate. On the other hand, trauma to the vessel wall during surgery, further placement of the CIED leads in the vessels, and perioperative stress can lead to even greater shifts towards hypercoagulation.

NCT ID: NCT04490759 Completed - Clinical trials for Coagulation Disorder

QStat Pilot Reference Range Study

Start date: November 29, 2018
Phase:
Study type: Observational

The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.

NCT ID: NCT04479280 Completed - Clinical trials for Coagulation Disorder

Evaluation of Coagulopathy in Critically Ill COVID-19 Patients.

Start date: July 20, 2020
Phase:
Study type: Observational

Novel coronavirus disease 19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), this pneumonia was first emerged in December 2019 in Wuhan, China and rapidly spread around the world . Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation

NCT ID: NCT04460664 Completed - COVID Clinical Trials

Coagulation Changes Associated With COVID-19 Infection

Start date: August 14, 2020
Phase:
Study type: Observational

This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.