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Thrombosis clinical trials

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NCT ID: NCT06242353 Not yet recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Coagulopathy in Childhood Acute Lymphoblastic Leukaemia

CoagCALL
Start date: March 1, 2024
Phase:
Study type: Observational

The goal of this study is to investigate the hemostatic balance in children with acute lymphoblastic leukaemia (ALL) treated according to the ALLTogether1 protocol with focus on the early treatment period including concomitant use of steroids and asparaginase. The investigators aim to determine if complement proteins or microparticles can be used as clinically relevant predictive or diagnostic biomarkers for thrombosis and if global hemostatic assays can predict bleeding or thrombosis. Characterization of proteins connected to hemostasis before and during ALL treatment may provide pathophysiological insights regarding ALL- and treatment related coagulopathy. The ultimate goal of the study is to minimize the morbidity and mortality related to thrombosis and bleeding complications in children with ALL. Several pediatric oncology centers in Sweden will be participating in this study, which will enroll approximately 100 pediatric patients.

NCT ID: NCT06232551 Not yet recruiting - Clinical trials for Deep Vein Thrombosis

Alerting Providers at Patient Hospital Discharge to Consider Prescribing Rivaroxaban to Reduce Venous Thromboembolism

eVTE
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

A new algorithm derived from only patient age and components of the complete blood count and basic metabolic panel can identify patients discharged from the hospital who may benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots, and for whom the risk of bleeding is minimal. The purpose of this study is to evaluate the use of a pop-up alert, which will be seen by clinicians when a discharging patient has been identified as being someone for whom the risk of blood clots is high, but for whom bleeding risk is estimated to be low. The pop-up alert will be enabled in a sequential fashion for each group of hospitals in 1 month blocks. We will look to see if the pop-up alert changes the number of patients who receive rivaroxaban. We will also measure the outcomes of blood clots and bleeding among all discharging patients.

NCT ID: NCT06232278 Not yet recruiting - Atrial Fibrillation Clinical Trials

Long-term Results of Percutaneous Left Atrial Closure at Brest University Hospital (CLAPOT)

CLAPOT
Start date: February 1, 2024
Phase:
Study type: Observational

Atrial Fibrillation represents an important risk of cardioembolic stroke. In more than 90% of cases, thrombus originate in the left atrial appendage. Therefore guidelines recommend the anticoagulation of patients with atrial fibrillation and a significant cardioembolic risk, predicted by the CHA2DS2VASc score. However, serious bleeding complications may definitively contraindicate the use of anticoagulants. For those patients, percutaneous Left Atrial Appendage Occlusion (LAAO) has became a recommended alternative to prevent the thrombus formation and reduce the risk of cardioembolic events. In the CHU of Brest, more than 120 patients have been treated with LAAO for the last 8 years with two different occluder devices : WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratories. This retrospective longitudinal observational study named CLAPOT (CHU of Brest' Left Atrial Appendage Percutaneous Occlusion Treatment) aims to evaluate the long term results of this procedure for effectiveness and safety and to compare the results between the two devices (Watchman and Amplatzer).

NCT ID: NCT06210334 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma With PVTT

HAIC Combine Tislelizumab and Lenvatinib in the Treatment of HCC With Type IV (Vp4) Portal Vein Tumor Thrombus (HAI-TL)

HAI-TL
Start date: March 2024
Phase: Phase 2
Study type: Interventional

To estimate the safety and efficacy of hepatic artery infusion chemotherapy (HAIC) combine Tislelizumab and Lenvatinib (HAI-TIS-LEN) in the Treatment of hepatocellular carcinoma (HCC) with type IV(Vp4) portal vein tumor thrombus (PVTT).

NCT ID: NCT06209892 Not yet recruiting - Anticoagulation Clinical Trials

Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular Thrombosis

Start date: January 2024
Phase: N/A
Study type: Interventional

A single-center, open-label, exploratory randomized controlled study is proposed with the following objectives: whether prolonging the duration of anticoagulation to 12 months, compared with 6 months of routine anticoagulation, helps to reduce major adverse cardiovascular and cerebrovascular events in patients with left ventricular thrombosis and to reduce recurrence of thrombosis, as well as to assess their bleeding risk. Patients with a definite diagnosis of left ventricular thrombus and age ≥18 years were included in cardiac ultrasound (including general ultrasound and sonography) and other examinations during hospitalization and outpatient visits. Exclusion criteria were detailed in the study protocol. GROUPING: According to the duration of anticoagulation, they were divided into extended anticoagulation group (12 months) and conventional anticoagulation group (6 months). INTERVENTION: This study is planned to extend the administration of rivaroxaban (Pulsatilla) 20 mg to 12 months in the experimental group. The conventional anticoagulation group will take the drug for 6 months Study Endpoints: The primary efficacy endpoint is a major cardiovascular-vascular adverse event at 1 year; the primary safety endpoint is bleeding of grade 3 or higher as defined by the BARC classification at 1 year. Patient Follow-up Program: Subjects will require a total of 12 on-site follow-up visits (one per month) for safety evaluation, efficacy evaluation, medication adherence evaluation, and imaging follow-up at months 3, 6, and 12.

NCT ID: NCT06195540 Not yet recruiting - Pulmonary Embolism Clinical Trials

RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing

RIVACAST
Start date: May 31, 2024
Phase: Phase 3
Study type: Interventional

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score <7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms. The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.

NCT ID: NCT06177704 Not yet recruiting - Clinical trials for Thromboembolic Event

Recurrent or Persistent Device Related Thrombus After Left Atrial Appendage Occlusion: The RE-DRT Study

RE-DRT
Start date: June 1, 2024
Phase:
Study type: Observational

This study is a prospective, multicenter international trial aimed at assessing the actual incidence, identifying associated factors, and evaluating the clinical consequences of both persistent and recurrent device-related thrombus (DRT) following percutaneous left atrial appendage occlusion (LAAO). While LAAO has shown efficacy in reducing the risk of stroke, device-related thrombus (DRT) remains a significant concern. The reported incidence of DRT varies, and it is associated with an elevated risk of ischemic stroke and death. The study highlights that persistent and recurrent DRT pose higher risks of thromboembolic events, and current data come from retrospective studies with non-standardized imaging follow-up protocols. The timing of imaging follow-up is crucial, and the study notes discrepancies in recommendations from expert statements. The EHRA/EAPCI suggests imaging at specific intervals post-procedure, while the SCAI/HRS recommends repeat imaging at shorter intervals to assess DRT resolution. The study underscores the need for dedicated prospective data to accurately determine the incidence, factors, and clinical impact of persistent and recurrent DRT after LAAO.

NCT ID: NCT06172738 Not yet recruiting - Clinical trials for Left Atrial Appendage Thrombosis

The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery.

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This study aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing open heart surgery, regardless of their preoperative AF status and stroke risk.

NCT ID: NCT06153394 Not yet recruiting - Thrombosis Clinical Trials

Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

PRIORITY
Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

This clinical trial will investigate the ability of thromboelastrogrpahy (TEG®) to detect hypercoagulability after liver surgery and will examine the effect of extended thromboprophylaxis (medical treatment to prevent the development of blood clots inside blood vessels) in patients undergoing liver surgery for cancer treatment. The liver plays a key role in regulating the process of blood clotting. As a result, blood clots are a major cause of complications and death following liver surgery. This is especially true in cancer patients who are at a higher risk of developing blood clots. Current methods for preventing clotting complications after liver surgery include conventional coagulation blood tests (CCTs) and anticoagulant drugs, such as low molecular weight heparins (LMWHs). Current LMWH treatment is prescribed for one month after surgery, but studies show that the risk of developing blood clots can last up to 3 months. Studies also show that CCTs may not be as effective in detecting clotting issues as more comprehensive testing systems, such as TEG. This study will randomize 50 participants to receive 90 days of thromboprophylaxis (using the LMWH Redesca) or the standard of care 30 days (using the LMWH Fragmin) after liver surgery. The medication will be given by injection, similar to a regular vaccine or an insulin injection. Participants will inject the medication every day, for 30 or 90 days, after surgery. Participants will also have their blood tested for clotting issues via TEG testing before surgery and on post-operative days 1,3,5,30 and 90. After surgery, participants will be monitored by their surgeon for clotting complications and 3 year disease-free survival.

NCT ID: NCT06152939 Not yet recruiting - Clinical trials for Left Ventricular Thrombus

Relation of Laboratory Indices to Left Ventricular Thrombus Formation in Patients With Acute Anterior ST Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention or Thrombolytic Therapy

Start date: January 1, 2024
Phase:
Study type: Observational

• to find the relationship between the different hematological indices including platelet indices, and blood cell ratios, to the development of LV thrombus in acute anterior STEMI patients managed by primary percutaneous coronary intervention (PPCI) , or thrombolytic therapy .