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Hepatic Veno-Occlusive Disease clinical trials

View clinical trials related to Hepatic Veno-Occlusive Disease.

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NCT ID: NCT03858530 Completed - Clinical trials for Stem Cell Transplant Complications

Ultrasound Elastography to Predict Development of SOS

Start date: May 1, 2018
Phase: Phase 4
Study type: Interventional

The long-term goal of our research is to accurately identify SOS patients who would benefit from defibrotide treatment using US SWE. The overall objective of this study is to validate SWE as an early diagnostic marker for SOS. Our central hypothesis is that SWE changes will precede clinical and conventional US diagnostic criteria for SOS. Our hypothesis has been formulated on the basis of our own preliminary data. The investigators completed the first prospective cohort trial demonstrating that US SWE provides SOS diagnosis (80% sensitivity and 67% specificity) nine days earlier than current clinical criteria. SWE is widely available, has no known side effects, and is easy to learn and interpret. Our study enrolled 25 high-risk BMT patients over 18 months (five with SOS and two with severe SOS). More data is needed to determine the optimal window for testing to balance between improved test characteristics and early detection of disease. The investigators propose conducting a prospective cohort study with 80 additional patients, 12 of which will likely develop SOS (including four with severe SOS) to optimize SWE timing. This study will increase the confidence in the findings from our preliminary study and allow us to test SWE against newly published clinical criteria. The rationale for the proposed research is that, if SWE can diagnose SOS earlier than clinical criteria, then SWE can guide early initiation of SOS treatment.

NCT ID: NCT03426358 Completed - Clinical trials for Stem Cell Transplant Complications

Liver Stiffness Measurement Predicts VOD/SOS Development (ELASTOVOD ITALIAN MULTICENTRIC STUDY)

ELASTOVOD
Start date: April 28, 2015
Phase: N/A
Study type: Interventional

ELASTOVOD is a prospective multicenter study, involving several centers of Onco-haematology in Italy. Investigators perform hepatic elastographic measurements (with Transient Elastography, ARFI or 2D-SWE) on patients undergoing HSCT, at baseline before transplantation (T0) and at T1/T2/T3 after HSCT (+9/10, +15/17, +22/24). SOS/VOD diagnosis was performed according to clinical criteria.

NCT ID: NCT03132337 Completed - Clinical trials for Sinusoidal Obstruction Syndrome

Sinusoidal Obstruction Syndrome for Stem Cell Transplant Patients Biomarker Study

SOSBiomarker
Start date: April 1, 2017
Phase:
Study type: Observational

The goal of this is to learn more about stem cell transplant and complications that some people have after their transplants, in particular sinusoidal obstruction syndrome (SOS), also called veno-occlusive disease of the liver.

NCT ID: NCT03032016 Completed - Clinical trials for Hepatic Veno-Occlusive Disease

European VOD Registry

Start date: April 24, 2015
Phase:
Study type: Observational

Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic stem cell transplantation (HSCT), as a specific obligation (SOB), the manufacture and marketing Authorisation Holder (MHA) (Gentium, a Jazz Pharmaceuticals Company) was required by PRAC (Pharmacovigilance Risk Assessment Committee) to set up a disease registry to collect safety and outcome data, and to assess patterns of utilization of Defitelio® in the post-approval setting. This registry is a Post Authorization Safety Study (PASS), is being coordinated in collaboration with the European Society for Blood and Marrow Transplantation (EBMT). For this study, anonymised clinical data are being collected from patients who develop VOD and and treated with and patients who have been treated with Defitelio® for conditions other than sVOD. The study DOES NOT involve decisions about treatment, which are clinical decisions, but merely collection of data for patients who develop this complication, whether or not they receive treatment and for patients who are treated with Defitelio® for any other reasons.The study DOES NOT involve decisions about treatment, which are clinical decisions, but merely collection of data for patients who develop this complication, whether or not they receive treatment and for patients who are treated with Defitelio® for any other reasons.

NCT ID: NCT02851407 Completed - Clinical trials for Veno-occlusive Disease

Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients

Start date: September 1, 2016
Phase: Phase 3
Study type: Interventional

This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.

NCT ID: NCT02483481 Completed - Clinical trials for Sinusoidal Obstruction Syndrome

Using Ultrasound Elastography to Predict Development of SOS

Start date: August 2015
Phase: N/A
Study type: Interventional

Sinusoidal obstruction syndrome (SOS) is a potentially fatal hepatic veno-occlusive disease-affecting children following bone marrow transplantation (BMT). SOS most likely develops secondary to sinusoidal endothelial damage and subsequent obstruction. The disease can be separated into mild, moderate, and severe forms; almost all patients diagnosed with severe SOS will die from this disease. Children with severe SOS suffer from multi-organ failure with signs and symptoms of portal hypertension (ascites, varices, edema), renal and respiratory failure . Although these children may be few and far between, the mere severity of the disease process and awful prognosis factors are valid reasons for more medical attention. SOS is usually diagnosed via clinical criteria and, despite available prophylaxis and treatment, children continue to die from this devastating disease. Quantitative shear wave ultrasound elastography with acoustic force radiation imaging is an emerging technology that uses ultrasound pressure waves to provide an estimate of tissue stiffness. This technique is promising for pediatric imaging because it is portable, quick to perform, relatively low cost and involves no ionizing radiation. Acoustic force radiation imaging and ultrasound elastography does not have any increased risks over conventional ultrasound imaging.

NCT ID: NCT01886248 Active, not recruiting - Clinical trials for Hepatic Veno-Occlusive Disease

Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation

Start date: June 2013
Phase: Phase 2
Study type: Interventional

To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.

NCT ID: NCT00885950 Completed - Clinical trials for Colorectal Liver Metastases

Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants

Start date: January 2008
Phase: N/A
Study type: Observational

The purpose of the study is to determine whether anticoagulant use (i.e. salicylates, clopidogrel, low-molecular weight heparin, or coumarin derivates) is able to prevent the development of the sinusoidal obstruction syndrome secondary to oxaliplatin-based neoadjuvant chemotherapy in patients suffering from colorectal liver metastases.

NCT ID: NCT00628498 Completed - Clinical trials for Hepatic Veno-Occlusive Disease

Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study

Treatment IND
Start date: December 2007
Phase: Phase 3
Study type: Interventional

Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.

NCT ID: NCT00563498 Recruiting - Mucositis Clinical Trials

Effects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients

Start date: July 2004
Phase: N/A
Study type: Interventional

The primary purpose of this project is to investigate if addition of glutamine, an amino acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow transplantation reducing the occurrence of veno-occlusive disease and severity of mucositis.