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

NCT04660266 | Unknown

• 1 other identifier: 0696-20-RMB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

VOD; Ultrasound Therapy; Complications

Outcome Measures

Primary Outcomes (1)

• Accuracy of liver ultrasound in predicting VOD

  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

Study Arms (1)

all cohort

OTHER

Diagnostic Test: Liver Ultrasound

Interventions

Liver Ultrasound DIAGNOSTIC_TEST

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

all cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Transplanted under 18 years of age.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israek, Israel

Location

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Central Study Contacts

Nira Beck Razi, MD

CONTACT

972502061204; n_beck_razi@mbam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 9, 2020
• Study Start: December 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

IL (1)