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Heparin-Induced Thrombocytopenia clinical trials

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NCT ID: NCT06033300 Recruiting - Clinical trials for Heparin-induced Thrombocytopenia

Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia

HITSTREAM
Start date: April 17, 2023
Phase: N/A
Study type: Interventional

The investigators would like to analyze platelet/leukoplak activation, quantify and morphologically characterize these aggregates using in vitro analysis, directly on whole blood from adult patients with suspected HIT. This would enable to better describe the in vivo pathophysiology of the HIT-suspect patient, and eliminate the need for platelet donors to perform the usual confirmatory techniques, whose inter- and intra-individual variability is very high. What's more, the SRA test, evaluated as the reference test, requires the use of radioisotopes and is therefore only carried out in a few biological expertise centers, resulting in a very long delay in the delivery of results. It should also be noted that, in practice, HÉPARINE is immediately stopped in patients with suspected HIT, and they are put on an expensive anticoagulant (DANAPAROIDE SODIQUE or ARGATROBAN) in curative doses until the results of the confirmatory tests are back. In this serious, life-threatening condition, it is essential to have a sensitive, specific test to confirm HIT as quickly as possible. Each patient with suspected HIT (rapid >30% reduction in platelet count after initiation of heparin therapy) should have 4 tubes of 3.2% citrated whole blood (2.7ml) collected at the time of suspected HIT (D0) and before any therapeutic switch (or 24 h max after switch). A new sample (4 citrated tubes) will be taken at D4, D7 and D14 during hospitalization, in patients who test positive for anti-PF4/H Ac. All patients with suspected HIT will follow the standard diagnostic pathway, i.e. a screening test (immunological test for anti-PF4/heparin antibodies, total Ig, ACL TOP, Werfen) followed by a confirmatory test (platelet aggregation on TA-8V, STAGO and/or SRA). Doppler ultrasonography of the lower limbs will be performed in HIT-suspect patients with a positive anti-PF4/H antibody test, as currently performed as part of routine care.

NCT ID: NCT05785819 Recruiting - Clinical trials for Heparin Induced Thrombocytopenia

A Phase 2 Study of VLX-1005 Versus Placebo in Suspected Heparin Induced Thrombocytopenia

Start date: September 26, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of VLX-1005, a 12-lipoxygenase (12-LOX) enzyme inhibitor in treating heparin induced thrombocytopenia (HIT). Participants with suspected HIT will receive the usual standard of care, and will be assigned randomly to either VLX-1005 or placebo treatment. The study will measure important outcomes including platelet count, stroke, pulmonary embolus (clot to the lungs) and bleeding.

NCT ID: NCT05783895 Recruiting - Clinical trials for Heparin-induced Thrombocytopenia

Comparison of Pre-test Probability Model for Heparin-induced Thrombocytopenia in Post-operative Cardiac Surgery

TicTac
Start date: March 1, 2023
Phase:
Study type: Observational

Heparin-induced thrombocytopenia (HIT) is a pro-thrombotic immunological condition that occurs in some patients exposed to heparin. The incidence of HIT is estimated at 0.1 to 0.3% of patients exposed to heparin, and rises to 3% in postoperative cardiac surgery. Cardiac surgery under CEC requires the use of high doses of heparin, which contributes to the increased incidence of HIT in this population. This high incidence is also explained by the comorbid profile of cardiac surgery patients, who often present risk factors for HIT (perioperative context, atrial fibrillation, organ failure, previous exposure to heparin, etc.). When it occurs postoperatively in cardiac surgery, there is a 28% increase in mortality, a 50% increase in morbidity, and an increase in hospitalization costs and length of stay. Although usually detected in medical wards on the basis of probability scores (4T, HEP), its diagnosis is less easy in postoperative cardiac surgery. Because of the many differential diagnoses, the screening scores usually used are less effective, and HIT is often diagnosed late, in patients who may have already developed a thromboembolic complication, which sometimes proves fatal. In addition, the diagnostic tests for HIT are compromised and lose their sensitivity in postoperative cardiac surgery, given the high incidence of seroconversion observed after extracorporeal circulation. Indeed, more than 50% of patients have antibodies to PF4/heparin, but only 1 to 2% of them have true HIT.These elements highlight the need to develop effective screening scores for HIT in postoperative cardiac surgery, given the complications to which patients are exposed in the event of underdiagnosis but also in the event of overdiagnosis. Other screening scores are being studied, not yet validated in cardiac surgery, such as the CPB score or the GFHT score. Early recognition of HIT would reduce the morbidity and mortality associated with this condition. The present study should make it possible to identify the most effective HIT probability score among those used in routine screening and thus to orient towards screening for this condition as early as possible, and consequently reduce the associated morbidity.

NCT ID: NCT04842760 Recruiting - Clinical trials for Heparin-induced Thrombocytopenia

PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

PLATELETSTREAM
Start date: June 1, 2021
Phase:
Study type: Observational

Platelets are essential blood elements to maintain hemostasis. Quantitative or qualitative defects can be responsible of hemorrhagic (platelet disorders) or thrombotic (heparin induced thrombocytopenia [HIT]) troubles. Diagnosis of these pathologies is sometimes urgent and consists in delicate platelet functional assays that are mostly made in expert centers. These platelets functional assays measure platelets activation and/or aggregation in response to diverse inductors and may lack sensitivity. The investigators would like to propose a new diagnostic tool with the use of imaging flow cytometry which provides much more information than classic cytometer on cell morphology thanks to images collected by the optical channel of the ImageStream cytometer. The use of this cytometer offers an innovative approach. This study is a monocentric prospective and non-interventional study. The investigators will analyze patient samples with the ImageStream cytometer and reference laboratory tests (light transmission aggregometry and serotonin release assay) in parallel and compare results from the different techniques. This new diagnostic technique will demonstrate a non-inferiority diagnosis compared to reference tests and maybe a better sensibility.

NCT ID: NCT04751357 Recruiting - Clinical trials for Heparin-induced Thrombocytopenia

Argatroban Monitoring in Critically Ill Patients: Evaluation of a Novel Ecarin-based Bedside Test

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

Argatroban is a parenteral direct Thrombininhibitor used for anticoagulation in patients suffering from heparin induced thrombocytopenia (HIT). There is increasing evidence suggesting that the activated partial thromboplastine time (aPTT), which is recommended for dosage monitoring, correlates poorly with serum argatroban concentration in critically ill patients. Therefore it may be badly suited to determine the correct dosing. Ecarin based tests have been proven to be effective in determining effects of direct thrombin inhibitors. The investigators now plan to evaluate a novel, rotational thrombelastometric, ecarin based bedside test for its ability to measure the effect of argatroban in critically ill patients. So far an excellent correlation of a similar test could be shown in spiked plasma of healthy adults. According to the manufacturer the ECA-Test is able to detect direct thrombininhibitors. However to our knowledge neither the ECA-Test nor other ecarin-based thrombelastometric tests have been studied in critically ill patients treated with argatroban. The investigators therefore seek to investigate the correlation of the ECA-Test (ClotPro®) with the serum argatroban concentration.

NCT ID: NCT03147638 Recruiting - Clinical trials for Heparin-induced Thrombocytopenia

Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)

HIT
Start date: January 11, 2017
Phase: Phase 3
Study type: Interventional

Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)

NCT ID: NCT02717039 Recruiting - Clinical trials for Heparin-induced Thrombocytopenia

Pharmacogenomics of Heparin-Induced Thrombocytopenia

PHIT
Start date: March 2016
Phase:
Study type: Observational

The purpose of this research is to identify genomic markers that can predict heparin-induced thrombocytopenia (HIT), which is a very serious side effect to heparin. Heparin is commonly used to prevent blood clots and the investigators may be able to identify genomic markers which can be used to prevent heparin use in people who will get HIT.

NCT ID: NCT01102790 Recruiting - Thrombosis Clinical Trials

Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure

Start date: April 2010
Phase: N/A
Study type: Observational

The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.