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NCT ID: NCT05634863 Completed - Clinical trials for Renal Vein Thrombosis

CONtinuous Implantable DOppler Probe Monitoring in Renal Transplantation

CONDOR
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

INTRODUCTION Vascular complications in kidney transplantation constitute one-third of the early graft loss (EGL) that can be prevented by timely diagnosed cases. A vascular monitoring device may have a possible role in the early identification of graft hypoperfusion critical to reducing graft loss. AIM To evaluate the feasibility of an Implantable Doppler probe as a vascular monitoring device in kidney transplant patients and by obtaining the vital information, inform the protocol development of a definitive RCT. METHODS AND ANALYSIS A mixed-method research design is selected. The quantitative study will comprise a feasibility RCT (fRCT) that will compare demographical characteristics and surgical outcomes of patients that will undergo kidney transplant surgery with vascular monitoring device (intervention group, n=25) against those with standard care clinical observation (control group, n=25). Descriptive statistics will be used to summarise the results that will assess the vascular monitoring capability of implantable Doppler probe in the early postoperative period of kidney transplant patients. The results will provide estimates for surgical outcomes essential to inform the sample size calculation for the definitive study. Information related to the fluency of research methods, availability of research resources, management support, potential challenges faced during the fRCT will be compiled to generate realistic estimates of important parameters for the definitive study. The results will be following the CONSORT updated guidelines for reporting feasibility studies. Qualitative semi-structured interviews of stakeholders (n=12) recruited by purposive sampling will be conducted to explore their experiences of participating in the study, acquire suggestions regarding application of implantable Doppler probe monitoring, and the post implantation patient care. All interviews will be audio-recorded with verbatim transcription. Data will be analysed following the six-phase guide to doing thematic analysis in the NVivo software. The results will be reported in accordance with the consolidated criteria for reporting qualitative research (COREQ) checklist. IMPACT It is anticipated that this study will also elaborate on a possible role of implantable Doppler probe monitoring to improve kidney transplant patient safety, graft survival, service quality improvement, and financial savings in the NHS.

NCT ID: NCT05621915 Completed - COVID-19 Clinical Trials

Nadroparin Pharmacokinetics in Different Stages of COVID-19

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

Objective: The risk of thrombotic complications in critical COVID-19 patients remains extremely high, and multicenter trials failed to prove the survival benefit of escalated doses of low molecular weight heparins (LMWH) in this group. The aim of this study was to develop a pharmacokinetic model of LMWH (nadroparin calcium) according to different stages of COVID-19 severity. Design: The investigators performed a prospective observational study. Patients: Blood samples were obtained from 43 COVID-19 patients that received nadroparin and were treated with conventional oxygen therapy, mechanical ventilation, and extracorporeal membrane oxygenation. Setting: The investigators recorded clinical, biochemical, and hemodynamic variables during 72 hours of treatment. The analyzed data comprised 782 serum nadroparin concentrations and 219 anti-factor Xa levels. The investigators conducted population nonlinear mixed-effects modeling (NONMEM) and performed Monte Carlo simulations of the probability of target attainment (PTA) for reaching 0.2-0.5 IU/ml anti-Xa levels in study groups. Interventions: None. Measurements and Main Results: The investigators successfully developed a one-compartment model to describe the population pharmacokinetics of nadroparin in different stages of COVID-19. Conclusions: Different nadroparin dosing is required for patients undergoing mechanical ventilation and ECMO to achieve the same targets as those for non-critically ill patients.

NCT ID: NCT05541978 Completed - Multiple Myeloma Clinical Trials

Thrombosis in Patients With Multiple Myeloma in an University Medical Center

THRIMM
Start date: September 1, 2022
Phase:
Study type: Observational

Main research question: What is the present venous thrombosis incidence and what are the current practices of prescribing thromboprophylaxis in patients with multiple myeloma (MM)? Design: The present study is a retrospective cohort study. The patients will be selected from the electronic patient dossier (EPD) of the University Medical Center Groningen (UMCG). The present study will include newly diagnosed adult patients with a first MM at the UMCG between 1st of January 2014 and 1st of September 2021. The primary outcome of the study is the incidence of venous thromboembolism (VTE) with one year of diagnosis of MM. The investigators will also describe the various thromboprophylaxis regimens used and their corresponding VTE incidence. The secondary outcome will be the incidence of arterial thrombosis (AT) within the same period of time. Possible confounders are the therapy administered for MM, thromboprophylaxis type, age and patient comorbidities. Lastly, the third outcome will be a description of current thromboprophylaxis practices in the UMCG. Each outcome will be described separately. Expected results: Based on the study by de Waal et al in which they included 474 MM patients treated at the UMCG and at 4 hospitals in the province Friesland, the investigators expect to record a VTE incidence of approximately 15%.

NCT ID: NCT05541562 Completed - Clinical trials for Portal Vein Thrombosis

A Practical Nomogram Based on Systemic Inflammatory Markers for Predicting Portal Vein Thrombosis in Patients With Liver Cirrhosis

Start date: January 1, 2013
Phase:
Study type: Observational

Immunothrombosis has recently been used to describe the responses/mechanisms in thrombosis. Systemic inflammatory markers are prognostic markers for a variety of thrombotic conditions; however, their potential value in predicting portal vein thrombosis (PVT) is unknown. This study aimed to establish an easy-to-use nomogram based on systemic inflammatory markers to predict portal vein thrombosis (PVT) in patients with liver cirrhosis.

NCT ID: NCT05536167 Completed - Clinical trials for Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts

Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family

Start date: December 12, 2022
Phase:
Study type: Observational

The purpose of this post market study is to collect clinical data of the Arthesys Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission.

NCT ID: NCT05515120 Completed - Pulmonary Embolism Clinical Trials

Rivaroxaban Plus Aspirin to Manage Recurrent Venous Thromboembolic Events

Start date: January 3, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Venous thromboembolism affects around 10 million people per year worldwide, however, despite its high incidence, there is no systematic review or randomized trial focused on the treatment of patients with recurrent deep vein thrombosis (DVT) and/or or pulmonary embolism (PE) during anticoagulant treatment. The objective was to compare the use of Rivaroxaban plus Aspirin versus Acenocoumarol in patients with recurrent venous thromboembolism treated with rivaroxaban.

NCT ID: NCT05469282 Completed - Clinical trials for Deep Vein Thrombosis

CEFID-I (CEra Flow Improves DVT-1)

Start date: August 22, 2022
Phase: N/A
Study type: Interventional

The study is a single center clinical trial to evaluate the efficacy and safety of blood circulation improvement using an investigational medical device, which is a product on the market and it's name is Ceragem Master V6, for the risk group of Deep Vein Thrombosis (DVT) and the ordinary person. The study compares before and after the application by one time application.

NCT ID: NCT05464901 Completed - Clinical trials for Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; Anticoagulants

VTE and the Related Factors Associated With Higher Rates of PE After a DVT in Southwestern China

Start date: December 1, 2006
Phase:
Study type: Observational

Little is known about the current management status of venous thromboembolism (VTE) in Southwestern China. We aimed to investigate the status of anticoagulant administration in VTE in Southwestern China and assess the potential predictors of deep vein thrombosis (DVT) complicated pulmonary embolism (PE). We extracted data from YiduCloud database from December 2006 to November 2018 and performed a cross-sectional survey of VTE. The demographics, laboratory tests, and anticoagulants were collected and analyzed in the logistic regression model, classification tree and Random Forest model.

NCT ID: NCT05448248 Completed - Clinical trials for Cerebral Venous Sinus Thrombosis

Multicenter Registry Study Of Cerebral Venous Thrombosis In China (RETAIN-CH)

Start date: August 20, 2022
Phase:
Study type: Observational

This study will investigate the epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of cerebral venous thrombosis in China.

NCT ID: NCT05426564 Completed - Thrombosis Clinical Trials

Exploratory Assessment of the Quantra® System in Adult ECMO Patients

Start date: September 27, 2022
Phase:
Study type: Observational

This is a prospective, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure.