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Thrombosis clinical trials

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NCT ID: NCT04349189 Active, not recruiting - Sickle Cell Disease Clinical Trials

Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait

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

Background: Venous thromboembolism (VTE) includes the abnormal clotting of blood in a deep vein of the upper or lower limbs (deep vein thrombosis) that may travel to and block a blood vessel in the lung (pulmonary embolism). Some people with sickle cell disease (SCD)-a red blood cell disorder-seem to be at greater risk for developing these blood clots. Researchers want to study the blood of people with SCD and VTE as well as healthy people to develop better treatments to prevent blood clots. Objective: To study blood clotting in SCD because it is the most common cause of vascular death after a heart attack or stroke. Eligibility: People ages 18-80 who have SCD (with or without a history of blood clots) or the trait for SCD, and healthy volunteers Design: Participants will be screened with medical history, physical exam, and medical records review. They will give blood samples. Participants will have phone calls either every 3 months or once a year, for 2 years. They will give updates on their health. They may give additional medical records. The phone calls may last up to 30 minutes. If participants have a VTE or pain crisis episode, they may visit the Clinical Center. These visits may last up to 4 hours. They will repeat the screening tests and give blood samples. Some participants may be invited to take part in blood studies. After 2 years, some participants will have a follow-up visit at the Clinical Center. Participation will last for about 2 years.

NCT ID: NCT04294849 Active, not recruiting - Pulmonary Embolism Clinical Trials

Exercise Intolerance and Skeletal Muscle Bioenergetics in Children With Deep Venous Thrombosis

Start date: February 6, 2020
Phase: N/A
Study type: Interventional

This is a prospective cohort study of 30 patients who are 8-21 years of age with venous thromboembolism (VTE)- either lower extremity deep venous thrombosis (DVT) or pulmonary embolism (PE).

NCT ID: NCT04168203 Active, not recruiting - Pulmonary Embolism Clinical Trials

Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous Thromboembolism

HI-PRO
Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

Design: U.S.-based, single-center, randomized placebo-controlled trial. Brief Treatment Description: Low-intensity apixaban (2.5mg twice daily) for extended-duration secondary prevention of VTE after initial treatment for provoked VTE. Purpose: To establish the safety and efficacy of low-intensity apixaban versus placebo for extended prevention of recurrence after provoked VTE in patients with at least one persistent provoking factor. Population: Outpatients with provoked VTE with at least one persistent provoking factor. Enrollment: 600 subjects Randomization: 1:1 Clinical Site Locations: 1 center (Brigham and Women's Hospital) Study Duration: 36 months; enrollment period of up to 20 months with 12-month follow-up. Primary Safety and Efficacy Outcomes: Primary Safety Outcome: International Society on Thrombosis and Haemostasis (ISTH) major bleeding at 12 months. Primary Efficacy Outcome: Symptomatic, recurrent VTE, defined as the composite of deep vein thrombosis and/or pulmonary embolism at 12 months. Secondary Efficacy Outcome: The composite of death due to cardiovascular cause, nonfatal myocardial infarction, stroke or systemic embolism, critical limb ischemia, or coronary or peripheral ischemia requiring revascularization (major adverse cardiovascular events, including major adverse limb events) at 12 months. Follow-Up: Follow-up will consist of Electronic Health Record (EHR) review at 12-months from study enrollment. Interim Analysis: An interim analysis for the primary safety and efficacy outcomes will be performed when 300 subjects have completed 12-month follow-up.

NCT ID: NCT04166825 Active, not recruiting - Endometriosis Clinical Trials

Ovarian Hyperstimulation and Fibrin Clot Properties.

Start date: November 18, 2019
Phase: N/A
Study type: Interventional

The impact evaluation of ovarian hyperstimulation on coagulation and fibrinolysis in infertile women. Comparative analysis between different ovarian stimulation protocols on thrombin formation and efficiency of fibrinolysis in women diagnosed with infertility.

NCT ID: NCT04096755 Active, not recruiting - Clinical trials for Deep Vein Thrombosis

Targeted Metabolic Profiling in Deep Vein Thrombosis

Start date: October 1, 2019
Phase:
Study type: Observational

Deep venous thrombosis(DVT) is a blood clot, usually affecting the legs, causing pain, swelling, and redness. The clot damages the veins, which can result in chronic pain, swelling and ulceration. This is called the post-thrombotic syndrome, which impacts heavily on patients' life and work. If the clot dislodges and travels to the lungs, it becomes a pulmonary embolus (PE), which can be life threatening. Together, DVT and PE affect 500,000 people in Europe every year, representing the most common cause of hospital acquired death. They are expensive diseases due to the cost of treatment and the days lost from people being unable to work. DVT is diagnosed by clinical examination, risk scoring and a blood test called D dimer, a product of the clot. If negative, it is unlikely that DVT is present. However, many conditions can raise D-dimer levels, making it less useful when positive. Ultrasound can confirm the presence of clot but often this is not seen. The clot can take time to form and patients may not experience symptoms immediately. This is a problem for treatment, as new, clot-busting medication works best in the first 2 weeks after a DVT and it is difficult to tell when the clot formed. Metabonomics is highly sensitive technology that detects very small chemicals; it is being used successfully in cancer and is a tool that can help better understand DVT and generate new tests to help patients. Previous departmental work has shown that a chemical difference exists in patients with DVT. The aim of this study is to not only confirm the presence of these chemicals in a different group of DVT patients, but also to calculate chemical concentrations. This will improve the investigator's understanding of how DVT develops and provide a way to develop a test that is better than D-dimer.

NCT ID: NCT03945045 Active, not recruiting - Venous Thrombosis Clinical Trials

A Study of the IJV or the SCV Approach for Ultrasound-guided Implantation of TIVAD

Start date: May 21, 2019
Phase: N/A
Study type: Interventional

To compare IJV and SCV as the implantation site of TIVAD and its associated thrombotic or occlusion rate, our study plans to enroll 240 patients with cancer who require central line TIVADs and randomizes them with 1:1 ratio to receive the TIVAD implantation at SCV or IJV. After the implantation, the patients will be regularly followed through phone contact and chart review for 2 years, and any symptomatic thrombosis or occlusion will be found during chemotherapy injection or regular push-pull heparin saline flush every 6 weeks as our hospital care protocol. To detect any asymptomatic thrombosis, the patients will also receive screening vascular ultrasound at 2 weeks, 2 months, and 6 months postoperatively. The study primary endpoints include any infection, asymptomatic thrombosis found by screen ultrasound, and clinically symptomatic thrombosis or occlusion and major mechanical failure/dislocation of TIVAD.

NCT ID: NCT03910933 Active, not recruiting - Health Literacy Clinical Trials

Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative

eKITE
Start date: June 30, 2017
Phase:
Study type: Observational

Effective patient education improves health literacy and engagement thus improving long-term health outcomes. Health literacy is imperative to make informed health decisions and relies on the ability to obtain, process and understand health information; and is the cornerstone of safe health management. It is necessary to evaluate educational initiatives to determine their effectiveness in knowledge translation. A more effective way to provide patient education is to utilize media technology. Current education styles do not teach patients in the best way as they are not consistent with how people of all ages currently learn (through technology). In addition, patient teaching most commonly occurs during highly stressful times like hospital visits with new diagnoses. Current patient educational methods are costly given the amount of health provider time required. Electronic KITE teaching modules are infographic visual representations that present information quickly and clearly, integrating words and graphics to tell a story to reveal information. Infographic presentations are tools which facilitate self-directed learning with understandable, accessible information presented in an engaging way with an aim to enhance learning for children and their families. Patients are able to learn at a pace consistent with their learning style to facilitate knowledge development and health literacy.

NCT ID: NCT03692065 Active, not recruiting - Clinical trials for Cancer-associated Thrombosis

API-CAT STUDY for APIxaban Cancer Associated Thrombosis

API-CAT
Start date: October 11, 2018
Phase: Phase 3
Study type: Interventional

The main objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent venous thromboembolism (VTE) in patients with active cancer who have completed at least 6 months of anticoagulant therapy for treating a documented index event of proximal deep venous thrombosis (DVT) (symptomatic or incidental) or pulmonary embolism (symptomatic or incidental).

NCT ID: NCT03650127 Active, not recruiting - Type 2 Diabetes Clinical Trials

Returning Genome and Metabolome Data to FinTerveys 2017 Participants: P5.fi FinTerveys Study

P5
Start date: February 2, 2018
Phase:
Study type: Observational

P5.fi study - P4 together with a fifth 'P' and '.fi' for population health Finally Implemented in Finland - studies the value of returning genetic and metabolomic risk information in two diseases (coronary heart disease and type 2 diabetes) and one feature (venous thromboembolism). The hypothesis of the study is that 1) combining genetic and metabolic risk with traditional risk factors adds value to the personal risk assessment of these diseases, 2) such risk information can be provided to individuals using a web based user portal in an easily understandable and useful format, and 3) receiving genetic and metabolomic risk information has an effect on the health of the study participants. The study is a continuation of FinHealth 2017 -study, which involved more than 7,000 Finns from around the country. The participants of FinHealth were invited to participate in P5.fi -study. The new research utilises information, samples, and measurements obtained in the FinHealth Study. Prospective clinical significance of selected genetic and metabolomic risk scores will be studied in 30.000 Finnish individuals. The study will analyze the genetic and metabolomic profile of the P5.fi participants and develop and test a protocol for returning them health related risk information. The impact of the intervention will by followed up by questionnaires and national health registers for five years.

NCT ID: NCT03575364 Active, not recruiting - DVT Clinical Trials

ClotTriever Outcomes (CLOUT) Registry

CLOUT
Start date: September 1, 2018
Phase:
Study type: Observational [Patient Registry]

Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.