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Coagulation Disorder clinical trials

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NCT ID: NCT06372483 Recruiting - Clinical trials for Coagulation Disorder

Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant

Start date: February 21, 2024
Phase: Phase 1
Study type: Interventional

A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts: Part 1: Single dose of VMX-C001 or placebo in healthy volunteers. Part 2: Single dose of VMX-C001 or placebo in combination with a selected factor 10a (FXa) direct oral anticoagulant (DOAC) in healthy older subjects.

NCT ID: NCT06154018 Completed - Cardiac Surgery Clinical Trials

Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass.

Start date: March 18, 2023
Phase: N/A
Study type: Interventional

Protamine is routinely used as a heparin reversal agent in cardiac surgery. However, its use may be associated with adverse events, while protamine excess may have additional anti-coagulant affect. Although guidelines advise towards a diminished reversal ratio, clinical practice remain heterogenic. The purpose of this study is to compare two different reversal ratios (0.6:1 και 0.8:1) of total heparin regarding the Activated Clotting Time (ACT), viscoelastic assays (Clot-Pro) and clinical hemorrhage. A baseline ACT value and Clot Pro tests will be obtained prior to the operation start. After the initial reversal, ACT, Clot Pro tests will be conducted again. Coagulation factors are administrated according to Clot Pro results, and in case of ongoing clinical hemorrhage and any indication of heparin excess in the measured values, another 25mg of protamine is administrated, while tests are repeated.

NCT ID: NCT06071559 Completed - Surgery Clinical Trials

Bariatric Surgery on obesity-and Diabetes-associated Abnormalities of Hemostasis, Inflammation and Vascular Function.

FIBRINO
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

The goal of this prospective cohort study is to examine circulating biomarkers before and after weight loss in patients with obesity, with or without concomitant diabetes, undergoing bariatric surgery. The main questions that are being addressed are: - Do biomarkers of hemostasis, including coagulation, fibrinolysis, and platelet function improve following surgery and if so, is that improvement more pronounced in patients with diabetes? - Do biomarkers of endothelial function and other aspects of vascular function improve following surgery and if so, is that improvement more pronounced in patients with diabetes? - Do biomarkers of inflammation, including markers of adipocyte function, improve following surgery and if so, is that improvement more pronounced in patients with diabetes? - The possible role of circulating extracellular vesicles reflecting biological functions above will also be investigated (optional) Participants will be asked to attend in total five study visits before and after surgery including a final visit at two years post-surgery. Comparisons will be performed within- as well as between groups.

NCT ID: NCT05998733 Recruiting - Sepsis Clinical Trials

The Impact of Coagulation Disorders on the Diagnosis and Prognosis of Sepsis

Start date: June 1, 2022
Phase:
Study type: Observational

The study was a retrospective, single-center clinical study. From all patients admitted to the emergency ICU during the period of 2013.1.1-2019.12.31, the investigators screened all patients who met the criteria of 1) ≤7 days from symptom onset to enrollment; 2) patients who also met the criteria of the presence of clinical infections and Sequential Organ Failure Assessment (SOFA) score ≥2; and 3) met the exclusion criteria, and retrospectively collected coagulation indices of the patients before anticoagulation with or without the use of heparin or low molecular heparin, and recorded the worst values of coagulation function of patients before heparin were recorded, and the organ function, inflammatory response, immune indexes, and conversion rate of severe disease were observed, so as to investigate the role of conventional coagulation indexes (FDP, D-dimer) and thromboelastography in the early diagnosis of septicemia patients and to indicate the prognosis.

NCT ID: NCT05957120 Completed - Inflammation Clinical Trials

Subclinical Impairment of Cardiovascular System in Patients With Psoriasis

PaS
Start date: January 3, 2022
Phase:
Study type: Observational

A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, treated with five different types of antipsoriatic treatment, and 20 healthy patients. All 100 subjects will be subjected to anthropometric measurements, blood will be collected for laboratory tests, and an imaging test will be performed to determine the function of the endothelium and arterial stiffness. The results will then be statistically analyzed.

NCT ID: NCT05824013 Completed - Clinical trials for Coagulation Disorder

Blood Coagulation Profile After Liver Resection.

Start date: April 12, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05645081 Recruiting - Stroke, Ischemic Clinical Trials

Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

PREDICT-EV
Start date: October 1, 2021
Phase:
Study type: Observational

Annually 100,000 strokes occur, placing stroke as the largest cause of disability in the UK. 90% of strokes are preventable, leading to national focus on programmes including "The National Stroke Programme" to act on preventing, treating, and improving post-stroke care. Importantly, over 25% of ischaemic stroke sufferers have previously had a Transient Ischaemic Attack (TIA), which presents the biggest concern for TIA patients. There are no measures which reliably identify TIA patients most likely to suffer a stroke. Novel biomarkers for predicting stroke are key to addressing this problem. The PREDICT-EV study aims to screen 300 TIA patients and follow them over 12-months. The investigators will determine if a novel biomarker we've identified to increase thrombotic risk (endothelial derived extracellular vesicles) and the resulting increased prothrombin time is associated with patients at highest risk of stroke.

NCT ID: NCT05496816 Completed - Sepsis Clinical Trials

Coagulation Disturbances in COVID-19 Septic Patients

Start date: January 1, 2021
Phase:
Study type: Observational

Objective of this study was to determine the relationship between CAC and septic condition in COVID-19 critically ill patients. Data including age, sex, comorbidities, quick Sequential Organ Failure Assessment (qSOFA) score, vasopressors requirement, laboratory findings: platelets, neutrophils, lymphocytes, procalcitonin (PCT), C-reactive protein (CRP), fibrinogen, D-dimer, sepsis-induced coagulopathy (SIC) and disseminated intravascular coagulation (DIC) score were recorded on the day of admission and on the day of starting of invasive mechanical ventilation. Primary outcome was to establish CAC with sepsis; secondary outcome measure was incidence of CAC in sepsis and septic shock in COVID-19 critically ill patients.

NCT ID: NCT05484830 Recruiting - Clinical trials for Coagulation Disorder

Coagulation in Acute Aortic Dissection

CAAD
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05272475 Completed - Clinical trials for Coagulation Disorder

The Acute Effects of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers

Start date: March 16, 2022
Phase: N/A
Study type: Interventional

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.