An interventional study of LSM assessed by Elastographic Techniques in Veno Occlusive Disease, Hepatic, Sinusoidal Obstruction Syndrome and Stem Cell Transplant Complications, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Completed at 37 sites in Italy. Open to participants aged 3 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Diagnostic
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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.
Sinusoidal Obstruction Syndrome (SOS), also known as hepatic Veno-Occlusive Disease (VOD), is a life-threatening complication in patients undergoing Hematopoietic Stem Cells Transplantation (HSCT) for onco-haematological disease.
In the severe form, mortality rate can be high as 80%. Patients developing SOS/VOD present a higher survival rate when earlier SOS/VOD- specific therapy has initiated. In order to get better outcomes, it is necessary to improve early diagnosis of SOS/VOD, finding new non--invasive diagnostic instruments.
The aim of this prospective multicenter study is to assess in a large, mixed (adult and paediatric) population undergoing HSCT, the diagnostic role for SOS/VOS of Liver Stiffness Measurement (LSM), assessed by different elastographic methods.
In our study, Liver Stiffness Measurement (LSM) can be measured by Transient Elastography (TE) with Fibroscan, Acoustic Radiation Force Impulse (ARFI) or 2D-Share Wave Elastography (2D-SWE). Once chosen an elastometric method at baseline, the same must be used for all subsequent evaluations of the patient.
In patients undergoing HSCT, within one month, a complete baseline evaluation is provided. Baseline evaluation (T0) includes: signature of informed consent, haematological and hepatological anamnesis, in order to assess comorbidities and risk factors for hepato-biliary complications; complete laboratory tests; abdominal Color-Doppler Ultrasound and hepatic Elastography (with Transient Elastography, ARFI or 2D-SWE).
After conditioning and HSCT, each patient is evaluated at T1 (+9/10), T2 (+15/17), T3 (+22/24) with: bedside Elastography, laboratory tests, clinical examination based on clinical criteria for SOS/VOD diagnosis (e.g. Baltimora criteria, modified Seattle criteria, new EBMT criteria).
RUCAM-CIOMS Scale can be assess, in order to establish DILI (Drug Induced Liver Injury) diagnosis, as well.
In case of SOS/VOD suspicion, patient goes through an intense monitoring period: laboratory tests, clinical evaluation for SOS/VOD diagnosis, Color-Doppler US and Elastography are repeatedly performed in next days. This monitoring period stops if diagnosis of SOS/VOD or other diagnosis is reached.
Each center will prospectively collect data according to an electronic e-CFR on REDCap (Research Electronic Data Capture) system, a web application designed to support data capture for research studies in a secure manner.
23 studies on the registry are indexed under Hepatic Veno-Occlusive Disease; 3 are open to participants now.
This study's enrollment of 1,101 is above the median of 80 across 15 interventional studies indexed under Hepatic Veno-Occlusive Disease.
Browse Hepatic Veno-Occlusive Disease studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 513 studies on the registry; 288 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LSM assessed by Elastographic Techniques
Device: LSM assessed by Elastographic Techniques
Performing Transient Elastography, ARFI or 2D-SWE on patients at baseline (within 1 month before HSCT) and after HSCT on days +9/10, +15/17, +22/24
Diagnostic Role of Liver Stiffness Measurement in SOS/VOD development
To assess in a large, mixed (adult and paediatric) population undergoing HSCT, the role of Liver Stiffness Measurement (LSM), assessed by different elastographic methods, in SOS/VOD diagnosis.
Time frame: From HSCT to 30 days after HSCT
Plan to share: Undecided
Ran from Apr 2015 to primary completion in Dec 2021, 80 months.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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