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

NCT03426358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1101

Last updated 2022-04-14

No results posted yet for this study

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, +22/24).

SOS/VOD diagnosis was performed according to clinical criteria.

Conditions

  • Veno Occlusive Disease, Hepatic
  • Sinusoidal Obstruction Syndrome
  • Stem Cell Transplant Complications

Interventions

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

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Antonio Colecchia, M.D. · Azienda Ospedaliera-Universitaria Integrata di Verona

  • Francesca Bonifazi, Ph.D. M.D. · Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna

  • Andrea Passion, Prof. M.D. · Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-28
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03426358 on ClinicalTrials.gov