Veno Occlusive Disease, HepaticELASTOVODNCT03426358

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

A study testing LSM assessed by Elastographic Techniques in people with Veno Occlusive Disease, Hepatic and Sinusoidal Obstruction Syndrome, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 37 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 3 to 70 years
Conditions the study is for: Veno Occlusive Disease, Hepatic, Sinusoidal Obstruction Syndrome, Stem Cell Transplant Complications
What is being tested?: LSM assessed by Elastographic Techniques
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,101 participants
Where: 37 sitesItaly
Study dates: 28 Apr 2015to Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

male or female patients
age between 3 and 70
patients suffering from an onco-hematological disease that have an indication for either allogenic or autologous hematopoietic stem cells transplantation
obtaining of informed consent

Who cannot join

pathological obesity (BMI >40)
pacemaker of implantable defibrillator
presence of ascites at baseline

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

Italy37 sites

Azienda Ospedaliera-Nazionale SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
Ancona
Azienda Ospedaliero-Universitaria Consorziale - Policlinico di Bari
Bari
ASST Papa Giovanni XXIII Ospedali riuniti di Bergamo
Bergamo
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Bologna, BO
Azienda Sanitaria dell'Alto Adige
Bolzano
Spedali Civili di Brescia, UO Ematologia
Brescia
Policlinico Vittorio Emanuele - Presidio Ferrarotto
Catania
Azienda Ospedaliera-Universitaria Careggi
Florence
Azienda Ospedaliera-Universitaria Meyer
Florence
Ospedale Policlinico San Martino
Genova
Ospedale Vito Fazzi
Lecce
Ospedale dell'Angelo
Mestre
ASST Grande Ospedale Metropolitano Niguarda
Milan
Ospedale Maggiore Policlinico di Milano
Milan
Ospedale San Raffaele
Milan
Azienda Ospedaliera-Universitaria di Modena
Modena
Ospedale Pediatrico Pausilipon
Naples
Policlinico Federico II
Naples
Azienda Ospedaliero-Universitaria di Padova
Padova
Azienda Ospedaliera Ospedali riuniti Villa Sofia- Cervello
Palermo
Azienda Ospedaliero-Universitaria Ospedale Maggiore di Parma
Parma
Azienda Sanitaria Locale di Pescara
Pescara
Azienda Ospedaliero-universitaria Pisana, UO Ematologia
Pisa
Azienda Ospedaliero-Universitaria Pisana, UO Oncoematologia Pediatrica
Pisa
Arcispedale S. Maria Nuova di Reggio Emilia
Reggio Emilia
Policlinico Umberto I - Università la Sapienza
Roma, RM
Ospedale Pediatrico Bambino Gesù
Roma
Policlinico Tor Vergata
Roma
Policlinico Universitario A. Gemelli
Roma
Istituto Clinico Humanitas
Rozzano, Milano
Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza
Torino
Azienda Ospedaliera "Card. G. Panico"
Tricase, Lecce
Azienda Ospedaliero-Universitaria Integrata di Udine
Udine
Azienda Ospedaliero-Universitaria Integrata di Verona
Verona
Azienda Ospedaliera di Vicenza
Vicenza

Other trials in Italy

About this study

Official title: Usefulness of Liver Stiffness Measurement in Predicting Hepatic Veno-Occlusive Disease Development in Patients Who Undergo HSCT: a Multicentric Prospective Study

SOS/VOD diagnosis was performed according to clinical criteria.

Read the detailed description

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.

Conditions: Veno Occlusive Disease, Hepatic, Sinusoidal Obstruction Syndrome, Stem Cell Transplant Complications
Being tested: LSM assessed by Elastographic Techniques
Keywords: Veno Occlusive Disease, Sinusoidal Obstruction Syndrome, HSCT, Hematopoietic Stem Cell Transplantation, Stem Cell Transplant Complications, Liver Stiffness Measurement, Sinusoidal Obstructive Syndrome, Transient Elastography
Medical subject headings: Hepatic Veno-Occlusive Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LSM assessed by Elastographic TechniquesDevice
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

Study groups in NCT03426358
Study group	Role	What they receive
Patients undergoing HSCT	Experimental	LSM assessed by Elastographic Techniques Receives: Device: LSM assessed by Elastographic Techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From HSCT to 30 days after HSCT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Apr 2015Dec 2021

First posted8 Feb 2018
Study start28 Apr 2015
Primary completionDec 2021
Study completionDec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Veno Occlusive Disease, HepaticStudies of the same condition, open and under way.
More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: All the patients with onco-hematological disease and an indication for transplantation of hematopoietic stem cells will be consecutively studied.
Masking: None (open label)
Enrolment: 1,101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03426358
Sponsor's protocol ID: ELASTOVOD
Acronym: ELASTOVOD
Status last verified: Apr 2022
First submitted: 2 Feb 2018
Last updated: 14 Apr 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Wadleigh M, Ho V, Momtaz P, Richardson P. Hepatic veno-occlusive disease: pathogenesis, diagnosis and treatment. Curr Opin Hematol. 2003 Nov;10(6):451-62. doi: 10.1097/00062752-200311000-00010.
PubMed 14564177
McDonald GB. Hepatobiliary complications of hematopoietic cell transplantation, 40 years on. Hepatology. 2010 Apr;51(4):1450-60. doi: 10.1002/hep.23533.
PubMed 20373370
Carreras E, Diaz-Beya M, Rosinol L, Martinez C, Fernandez-Aviles F, Rovira M. The incidence of veno-occlusive disease following allogeneic hematopoietic stem cell transplantation has diminished and the outcome improved over the last decade. Biol Blood Marrow Transplant. 2011 Nov;17(11):1713-20. doi: 10.1016/j.bbmt.2011.06.006. Epub 2011 Jun 25.
PubMed 21708110
Jones RJ, Lee KS, Beschorner WE, Vogel VG, Grochow LB, Braine HG, Vogelsang GB, Sensenbrenner LL, Santos GW, Saral R. Venoocclusive disease of the liver following bone marrow transplantation. Transplantation. 1987 Dec;44(6):778-83. doi: 10.1097/00007890-198712000-00011.
PubMed 3321587
McDonald GB, Sharma P, Matthews DE, Shulman HM, Thomas ED. Venocclusive disease of the liver after bone marrow transplantation: diagnosis, incidence, and predisposing factors. Hepatology. 1984 Jan-Feb;4(1):116-22. doi: 10.1002/hep.1840040121.
PubMed 6363247
Mohty M, Malard F, Abecassis M, Aerts E, Alaskar AS, Aljurf M, Arat M, Bader P, Baron F, Bazarbachi A, Blaise D, Ciceri F, Corbacioglu S, Dalle JH, Dignan F, Fukuda T, Huynh A, Masszi T, Michallet M, Nagler A, NiChonghaile M, Okamoto S, Pagliuca A, Peters C, Petersen FB, Richardson PG, Ruutu T, Savani BN, Wallhult E, Yakoub-Agha I, Duarte RF, Carreras E. Revised diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in adult patients: a new classification from the European Society for Blood and Marrow Transplantation. Bone Marrow Transplant. 2016 Jul;51(7):906-12. doi: 10.1038/bmt.2016.130. Epub 2016 May 16.
PubMed 27183098
Corbacioglu S, Carreras E, Ansari M, Balduzzi A, Cesaro S, Dalle JH, Dignan F, Gibson B, Guengoer T, Gruhn B, Lankester A, Locatelli F, Pagliuca A, Peters C, Richardson PG, Schulz AS, Sedlacek P, Stein J, Sykora KW, Toporski J, Trigoso E, Vetteranta K, Wachowiak J, Wallhult E, Wynn R, Yaniv I, Yesilipek A, Mohty M, Bader P. Diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in pediatric patients: a new classification from the European society for blood and marrow transplantation. Bone Marrow Transplant. 2018 Feb;53(2):138-145. doi: 10.1038/bmt.2017.161. Epub 2017 Jul 31.
PubMed 28759025
Dignan FL, Wynn RF, Hadzic N, Karani J, Quaglia A, Pagliuca A, Veys P, Potter MN; Haemato-oncology Task Force of British Committee for Standards in Haematology; British Society for Blood and Marrow Transplantation. BCSH/BSBMT guideline: diagnosis and management of veno-occlusive disease (sinusoidal obstruction syndrome) following haematopoietic stem cell transplantation. Br J Haematol. 2013 Nov;163(4):444-57. doi: 10.1111/bjh.12558. Epub 2013 Sep 17.
PubMed 24102514
Sorror ML, Maris MB, Storb R, Baron F, Sandmaier BM, Maloney DG, Storer B. Hematopoietic cell transplantation (HCT)-specific comorbidity index: a new tool for risk assessment before allogeneic HCT. Blood. 2005 Oct 15;106(8):2912-9. doi: 10.1182/blood-2005-05-2004. Epub 2005 Jun 30.
PubMed 15994282
Richardson PG, Smith AR, Triplett BM, Kernan NA, Grupp SA, Antin JH, Lehmann L, Miloslavsky M, Hume R, Hannah AL, Nejadnik B, Soiffer RJ. Earlier defibrotide initiation post-diagnosis of veno-occlusive disease/sinusoidal obstruction syndrome improves Day +100 survival following haematopoietic stem cell transplantation. Br J Haematol. 2017 Jul;178(1):112-118. doi: 10.1111/bjh.14727. Epub 2017 Apr 26.
PubMed 28444784
Berzigotti A, Castera L. Update on ultrasound imaging of liver fibrosis. J Hepatol. 2013 Jul;59(1):180-2. doi: 10.1016/j.jhep.2012.12.028. Epub 2013 Jan 15. No abstract available.
PubMed 23333447
Lassau N, Auperin A, Leclere J, Bennaceur A, Valteau-Couanet D, Hartmann O. Prognostic value of doppler-ultrasonography in hepatic veno-occlusive disease. Transplantation. 2002 Jul 15;74(1):60-6. doi: 10.1097/00007890-200207150-00011.
PubMed 12134100
Lassau N, Leclere J, Auperin A, Bourhis JH, Hartmann O, Valteau-Couanet D, Benhamou E, Bosq J, Ibrahim A, Girinski T, Pico JL, Roche A. Hepatic veno-occlusive disease after myeloablative treatment and bone marrow transplantation: value of gray-scale and Doppler US in 100 patients. Radiology. 1997 Aug;204(2):545-52. doi: 10.1148/radiology.204.2.9240551.
PubMed 9240551
Karlas T, Weber J, Nehring C, Kronenberger R, Tenckhoff H, Mossner J, Niederwieser D, Troltzsch M, Lange T, Keim V. Value of liver elastography and abdominal ultrasound for detection of complications of allogeneic hemopoietic SCT. Bone Marrow Transplant. 2014 Jun;49(6):806-11. doi: 10.1038/bmt.2014.61. Epub 2014 Apr 7.
PubMed 24710567
Auberger J, Graziadei I, Clausen J, Vogel W, Nachbaur D. Non-invasive transient elastography for the prediction of liver toxicity following hematopoietic SCT. Bone Marrow Transplant. 2013 Jan;48(1):159-60. doi: 10.1038/bmt.2012.113. Epub 2012 Jun 18. No abstract available.
PubMed 22705804

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Extrahepatic Portal Vein Obstruction (EHPVO)
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SAMe in Prevention of Oxaliplatin-associated Liver Injury
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RecruitingObservational study
A Prospective Registry of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS).
Hematopoietic Cell Transplantation
RecruitingPhase 2
Defibrotide Dose-escalation for SOS Post-HSCT
Sinusoidal Obstruction Syndrome, Veno-occlusive Disease
RecruitingObservational study
Cell Free DNA Profiling As a Tool to Monitor Clinically-Relevant Events in Allogeneic Hematopoietic Stem Cell Transplantation
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All Veno Occlusive Disease, Hepatic trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Usefulness of Liver Stiffness Measurement in Predicting Hepatic Veno-Occlusive Disease Development in Patients Who Undergo HSCT: a Multicentric Prospective Study
ClinicalTrials.gov ID: NCT03426358
Acronym / sponsor ID: ELASTOVOD / ELASTOVOD
Conditions: Veno Occlusive Disease, Hepatic, Sinusoidal Obstruction Syndrome, Stem Cell Transplant Complications
Keywords: Veno Occlusive Disease, Sinusoidal Obstruction Syndrome, HSCT, Hematopoietic Stem Cell Transplantation, Stem Cell Transplant Complications, Liver Stiffness Measurement, Sinusoidal Obstructive Syndrome, Transient Elastography
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,101 participants (actual)
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
Study start: 28 Apr 2015 (actual)
Primary completion: Dec 2021 (actual)
Study completion: Dec 2021 (actual)
First posted: 8 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

SOS/VOD diagnosis was performed according to clinical criteria.

Detailed description

RUCAM-CIOMS Scale can be assess, in order to establish DILI (Drug Induced Liver Injury) diagnosis, as well.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All the patients with onco-hematological disease and an indication for transplantation of hematopoietic stem cells will be consecutively studied.

Arm	Type	Receives
Patients undergoing HSCT	Experimental	Device: LSM assessed by Elastographic TechniquesLSM assessed by Elastographic Techniques

Who may qualify

Ages: 3 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

male or female patients
age between 3 and 70
patients suffering from an onco-hematological disease that have an indication for either allogenic or autologous hematopoietic stem cells transplantation
obtaining of informed consent

Key exclusion criteria (3 listed)

pathological obesity (BMI >40)
pacemaker of implantable defibrillator
presence of ascites at baseline

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LSM assessed by Elastographic TechniquesPerforming 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	Device	Patients undergoing HSCT

Primary outcome

Diagnostic Role of Liver Stiffness Measurement in SOS/VOD development
Time frame: From HSCT to 30 days after HSCT
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
Background: PubMed 14564177Wadleigh M, Ho V, Momtaz P, Richardson P. Hepatic veno-occlusive disease: pathogenesis, diagnosis and treatment. Curr Opin Hematol. 2003 Nov;10(6):451-62. doi: 10.1097/00062752-200311000-00010.
Background: PubMed 20373370McDonald GB. Hepatobiliary complications of hematopoietic cell transplantation, 40 years on. Hepatology. 2010 Apr;51(4):1450-60. doi: 10.1002/hep.23533.
Background: PubMed 21708110Carreras E, Diaz-Beya M, Rosinol L, Martinez C, Fernandez-Aviles F, Rovira M. The incidence of veno-occlusive disease following allogeneic hematopoietic stem cell transplantation has diminished and the outcome improved over the last decade. Biol Blood Marrow Transplant. 2011 Nov;17(11):1713-20. doi: 10.1016/j.bbmt.2011.06.006. Epub 2011 Jun 25.
Background: PubMed 3321587Jones RJ, Lee KS, Beschorner WE, Vogel VG, Grochow LB, Braine HG, Vogelsang GB, Sensenbrenner LL, Santos GW, Saral R. Venoocclusive disease of the liver following bone marrow transplantation. Transplantation. 1987 Dec;44(6):778-83. doi: 10.1097/00007890-198712000-00011.
Background: PubMed 6363247McDonald GB, Sharma P, Matthews DE, Shulman HM, Thomas ED. Venocclusive disease of the liver after bone marrow transplantation: diagnosis, incidence, and predisposing factors. Hepatology. 1984 Jan-Feb;4(1):116-22. doi: 10.1002/hep.1840040121.
Background: PubMed 27183098Mohty M, Malard F, Abecassis M, Aerts E, Alaskar AS, Aljurf M, Arat M, Bader P, Baron F, Bazarbachi A, Blaise D, Ciceri F, Corbacioglu S, Dalle JH, Dignan F, Fukuda T, Huynh A, Masszi T, Michallet M, Nagler A, NiChonghaile M, Okamoto S, Pagliuca A, Peters C, Petersen FB, Richardson PG, Ruutu T, Savani BN, Wallhult E, Yakoub-Agha I, Duarte RF, Carreras E. Revised diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in adult patients: a new classification from the European Society for Blood and Marrow Transplantation. Bone Marrow Transplant. 2016 Jul;51(7):906-12. doi: 10.1038/bmt.2016.130. Epub 2016 May 16.
Background: PubMed 28759025Corbacioglu S, Carreras E, Ansari M, Balduzzi A, Cesaro S, Dalle JH, Dignan F, Gibson B, Guengoer T, Gruhn B, Lankester A, Locatelli F, Pagliuca A, Peters C, Richardson PG, Schulz AS, Sedlacek P, Stein J, Sykora KW, Toporski J, Trigoso E, Vetteranta K, Wachowiak J, Wallhult E, Wynn R, Yaniv I, Yesilipek A, Mohty M, Bader P. Diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in pediatric patients: a new classification from the European society for blood and marrow transplantation. Bone Marrow Transplant. 2018 Feb;53(2):138-145. doi: 10.1038/bmt.2017.161. Epub 2017 Jul 31.
Background: PubMed 24102514Dignan FL, Wynn RF, Hadzic N, Karani J, Quaglia A, Pagliuca A, Veys P, Potter MN; Haemato-oncology Task Force of British Committee for Standards in Haematology; British Society for Blood and Marrow Transplantation. BCSH/BSBMT guideline: diagnosis and management of veno-occlusive disease (sinusoidal obstruction syndrome) following haematopoietic stem cell transplantation. Br J Haematol. 2013 Nov;163(4):444-57. doi: 10.1111/bjh.12558. Epub 2013 Sep 17.
Background: PubMed 15994282Sorror ML, Maris MB, Storb R, Baron F, Sandmaier BM, Maloney DG, Storer B. Hematopoietic cell transplantation (HCT)-specific comorbidity index: a new tool for risk assessment before allogeneic HCT. Blood. 2005 Oct 15;106(8):2912-9. doi: 10.1182/blood-2005-05-2004. Epub 2005 Jun 30.
Background: PubMed 28444784Richardson PG, Smith AR, Triplett BM, Kernan NA, Grupp SA, Antin JH, Lehmann L, Miloslavsky M, Hume R, Hannah AL, Nejadnik B, Soiffer RJ. Earlier defibrotide initiation post-diagnosis of veno-occlusive disease/sinusoidal obstruction syndrome improves Day +100 survival following haematopoietic stem cell transplantation. Br J Haematol. 2017 Jul;178(1):112-118. doi: 10.1111/bjh.14727. Epub 2017 Apr 26.
Background: PubMed 23333447Berzigotti A, Castera L. Update on ultrasound imaging of liver fibrosis. J Hepatol. 2013 Jul;59(1):180-2. doi: 10.1016/j.jhep.2012.12.028. Epub 2013 Jan 15. No abstract available.
Background: PubMed 12134100Lassau N, Auperin A, Leclere J, Bennaceur A, Valteau-Couanet D, Hartmann O. Prognostic value of doppler-ultrasonography in hepatic veno-occlusive disease. Transplantation. 2002 Jul 15;74(1):60-6. doi: 10.1097/00007890-200207150-00011.
Individual participant dataSharing planned: Undecided

Related trials for Veno Occlusive Disease, Hepatic

Enrolling by invitation
Radiological Intervention for Childhood Extra-Hepatic Portal Vein Obstruction
Extrahepatic Portal Vein Obstruction (EHPVO)
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingObservational study
A Prospective Registry of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS).
Hematopoietic Cell Transplantation
RecruitingPhase 2
Defibrotide Dose-escalation for SOS Post-HSCT
Sinusoidal Obstruction Syndrome, Veno-occlusive Disease
RecruitingObservational study
Cell Free DNA Profiling As a Tool to Monitor Clinically-Relevant Events in Allogeneic Hematopoietic Stem Cell Transplantation
GVHD - Graft-Versus-Host Disease, Infections After HSCT

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonio Colecchia, M.D. principal investigator

Azienda Ospedaliera-Universitaria Integrata di Verona

Francesca Bonifazi, Ph.D. M.D. study chair

Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna

Andrea Passion, Prof. M.D. study chair

Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna

37 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Role of Liver Stiffness Measurement in SOS/VOD development (time frame: From HSCT to 30 days after HSCT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03426358, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.