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

December 6, 2020 updated by: Rambam Health Care Campus

Accuracy of Ultrasound Exam, Including Doppler and Elastography, in the Diagnosis of VOD, in the 21 Days Following Bone Marrow Transplantation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

The test will include:

  1. Demonstration of liver including its size.
  2. Gallbladder demonstration including its width and wall thickness.
  3. Main portal vein width, Speed and flow direction in main portal vein.
  4. Evaluation of umbilical vein in the falciform ligament to check existence of flow and venous width in case it opened.
  5. Assessment of existence a small / medium or large amount of ascites measurement of resistance index in the main hepatic artery.
  6. Complete elastography examination.

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over the age of 18 before a bone marrow transplantation.

Exclusion Criteria:

  • Transplanted under 18 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: all cohort
Diagnostic test: Liver Ultrasound
liver ultrasound examination, including gray-scale and seven Doppler examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of liver ultrasound in predicting VOD
Time Frame: 21 days

ultrasound results inculding gray scale , doppler and elastography will be compared to the clinical diagnosis of VOD the diagnosis of VOD will be performed according to the Europian Society for Blood and Marrow transplantation revised criteria

  1. presence of ascites yes/no
  2. liver enlagement more than 17 cm
  3. Bilirubin >2 mg/dl
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

December 9, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 0696-20-RMB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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