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Hemostatic Disorders 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: NCT06291415 Recruiting - Hemorrhage Clinical Trials

The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)

Start date: April 2, 2024
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.

NCT ID: NCT06250595 Recruiting - Leukemia Clinical Trials

European Rare Blood Disorders Platform (ENROL)

ENROL
Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

ENROL, the European Rare Blood Disorders Platform has been conceived in the core of ERN-EuroBloodNet as an umbrella for both new and already existing registries on Rare Hematological Diseases (RHDs). ENROL aims at avoiding fragmentation of data by promoting the standards for patient registries' interoperability released by the EU RD platform. ENROL's principle is to maximize public benefit from data on RHDs opened up through the platform with the only restriction needed to guarantee patient rights and confidentiality, in agreement with EU regulations for cross-border sharing of personal data. Accordingly, ENROL will map the EU-level demographics, survival rates, diagnosis methods, genetic information, main clinical manifestations, and treatments in order to obtain epidemiological figures and identify trial cohorts for basic and clinical research. To this aim, ENROL will connect and facilitate the upgrading of existing RHD registries, while promoting the building of new ones when / where lacking. Target-driven actions will be carried out in collaboration with EURORDIS for educating patients and families about the benefits of enrolment in such registries, including different cultural and linguistic strategies. The standardized collection and monitoring of disease-specific healthcare outcomes through the ENROL user-friendly platform will determine how specialized care is delivered, where are the gaps in diagnosis, care, or treatment and where best to allocate financial, technical, or human resources. Moreover, it will allow for promoting research, especially for those issues that remain unanswered or sub-optimally addressed by the scientific community; furthermore, it will allow promoting clinical trials for new drugs. ENROL will enable the generation of evidence for better healthcare for RHD patients in the EU as the ultimate goal. ENROL officially started on 1st June 2020 with a duration of 36 months. ENROL is co-funded by the Health Programme of the European Union under the call for proposals HP-PJ-2019 on Rare disease registries for the European Reference Networks. GA number 947670

NCT ID: NCT06154018 Recruiting - 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: NCT06025552 Recruiting - Hemophilia A Clinical Trials

Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects

Start date: August 2, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1a, double-blind, randomized, placebo- controlled, SAD study to assess safety, tolerability, PK, and PD of TU7710 in warfarin treated healthy male participants.

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: NCT05975112 Recruiting - Clinical trials for Cesarean Section Complications

The Incidence of Hyperfibrinolysis During Vaginal Delivery and Cesarean Section

Start date: June 1, 2023
Phase:
Study type: Observational

This study aims to find out if there are common major changes in coagulation immediately after delivery of the newborn during Cesarean (C) -section and vaginal birth.

NCT ID: NCT05974111 Recruiting - Ischemic Stroke Clinical Trials

COAgulation Disorders in Ischaemic and Haemorrhagic Stroke

COADIHS
Start date: May 2, 2023
Phase:
Study type: Observational

In this study the investigators will assess both procoagulant and anticoagulant pathways using thrombin generation and platelet function tests; as well as neuronal ischemia using cell free DNA in all patients presenting with ischaemic and haemorrhagic stroke (including aneurysmal subarachnoid haemorraghe). Also the cross-talk between inflammation and thrombosis, so-called thrombo-inflammation is further investigated. As such the investigators aim to characterise the patient's coagulation profile before administration of any treatment. By assessing these pathways the investigators strive to detect specific markers to predict vital and functional outcome at 3 months in these patients. Finally the investigators may provide new pathophysiological insights in the course of disease following these events that can possibly improve future therapeutic strategies.

NCT ID: NCT05946863 Recruiting - Hip Fractures Clinical Trials

Caudal Block & Hip Fracture Surgery in Anticoagulated Patient

Start date: January 2, 2008
Phase:
Study type: Observational

Hip fractures are common in elderly patients, and require surgery. Many elderly patients take anticoagulants for vasculopathy treatment. Anticoagulation precludes the use of neuraxial anesthesia because of the risk of epidural bleeding. Caudal anesthesia may be a safe and effective technique in anticoagulated emergency surgical patients. Quantitative analysis of prospective clinical data. Evaluation of caudal anesthesia efficacy for hip fracture surgery. Analysis of perioperative outcome, and postoperative course.

NCT ID: NCT05946850 Recruiting - Clinical trials for Anticoagulants and Bleeding Disorders

Caudal Analgesia & Anticoagulated Patient

Start date: January 2, 2008
Phase:
Study type: Observational

Caudal analgesia is an effective intervention for lumbosacral pain. Some chronic pain patients take anticoagulants for vasculopathy treatment. Anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. Caudal analgesia may be safe and effective in anticoagulated chronic pain patients. Quantitative analysis of prospective clinical data. Evaluation of caudal analgesia efficacy and safety in anticoagulated chronic pain patients. Analysis of outcome, and complications.