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

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ClinicalTrials.gov Identifier: NCT04660266
Recruitment Status : Not yet recruiting
First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
VOD Ultrasound Therapy; Complications Diagnostic Test: Liver Ultrasound Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: liver evaluation by US before, 14 days and 21 days after bone marrow transplantation, in the purpose to predict the appearance of Veno occlusive disease.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accuracy of Ultrasound Exam, Including Doppler and Elastography, in the Diagnosis of VOD, in the 21 Days Following Bone Marrow Transplantation
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
all cohort Diagnostic Test: Liver Ultrasound
liver ultrasound examination, including gray-scale and seven Doppler examination


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Transplanted under 18 years of age.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660266


Contacts
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Contact: Nira Beck Razi, MD 972502061204 n_beck_razi@mbam.health.gov.il

Locations
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Israel
Rambam Medical Center
Haifa, Israek, Israel
Contact: NIRA BECK-RAZI, md    97247772664    n_beck_razi@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
More Information
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Additional Information:

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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT04660266    
Other Study ID Numbers: 0696-20-RMB
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No