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Accuracy of Ultrasound Exam, Including Doppler and Elastography, in the Diagnosis of VOD, Following Bone Marrow Transplantation

NCT04660266 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-12-09

No results posted yet for this study

Summary

The purpose of the study:

Validation of the use of intentional ultrasound examination, which includes Doppler and elastography for the diagnosis of obstructive venous disease of the liver within 21 days after bone marrow transplantation.

Protocol:

Patients who are planned for a bone marrow transplantaion will be recruited for the study by the staff of the Transplant Department. Inclusion criteria: Patients over the age of 18 before a bone marrow transplantation.

Eligibility criteria: Transplanted under 18 years of age

Research protocol:

After informed consent, patients will undergo an ultrasound examination before the transplant.

After 14 days and again after 21 days patients will undergo two more US exams, If there is a change in their clinical condition the patients will undergo additional examination accordingly.

At the same time on the 14th and 21st day a clinical evaluation will be performed by the clinical physician in the transplant department based on clinical criteria of European Blood and Brain Transplant Association (EBMT).

The results of the clinical evaluation and blood test results will be collected.

Patients will be divided into two groups:

* Control group: Patients who did not develop VOD( veno occlusive disease ) during 21 days.
* Study group: Patients who developed VOD during 21 days.

All ultrasound examination data will be compared between the two groups in

In addition will be collected:

* Demographics - age, sex.
* Background diseases including heart and liver diseases.
* Basic disease as a transplantation cause.

All data will be collected anonymously and coded separately.

Conditions

  • VOD
  • Ultrasound Therapy; Complications

Interventions

DIAGNOSTIC_TEST

Liver Ultrasound

liver ultrasound examination, including gray-scale and seven Doppler examination

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Israel

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 NCT04660266 on ClinicalTrials.gov