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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04660266
Enrollment
200
Registered
2020-12-09
Start date
2020-12-31
Completion date
2022-10-31
Last updated
2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound Therapy; Complications, VOD

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.

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.

Interventions

DIAGNOSTIC_TESTLiver Ultrasound

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

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Transplanted under 18 years of age.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of liver ultrasound in predicting VOD21 daysultrasound 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

Countries

Israel

Contacts

Primary ContactNira Beck Razi, MD
n_beck_razi@mbam.health.gov.il972502061204

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026