VODNCT04660266
Accuracy of Ultrasound Exam, Including Doppler and Elastography, in the Diagnosis of VOD, Following Bone Marrow Transplantation
A study testing Liver Ultrasound in people with VOD and Ultrasound Therapy; Complications, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VOD, Ultrasound Therapy; Complications
- What is being tested?
- Liver Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2020to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 before a bone marrow transplantation.
Who cannot join
- Transplanted under 18 years of age.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam Medical Center
Haifa, Israek
NIRA BECK-RAZI, md, 97247772664, n_beck_razi@rambam.health.gov.il
About this study
Official title: 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.
Read more
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.
Read the 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:
- Demonstration of liver including its size.
- Gallbladder demonstration including its width and wall thickness.
- Main portal vein width, Speed and flow direction in main portal vein.
- Evaluation of umbilical vein in the falciform ligament to check existence of flow and venous width in case it opened.
- Assessment of existence a small / medium or large amount of ascites measurement of resistance index in the main hepatic artery.
- 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.
- Conditions
- VOD, Ultrasound Therapy; Complications
- Being tested
- Liver Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver UltrasoundDiagnostic test
liver ultrasound examination, including gray-scale and seven Doppler examination
| Study group | Role | What they receive |
|---|---|---|
| all cohort | Other | Not described Receives: Diagnostic Test: Liver Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- presence of ascites yes/no
- liver enlagement more than 17 cm
- Bilirubin >2 mg/dl
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VODStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660266
- Sponsor's protocol ID
- 0696-20-RMB
- Status last verified
- Dec 2020
- First submitted
- 18 Nov 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Ultrasound Exam, Including Doppler and Elastography, in the Diagnosis of VOD, in the 21 Days Following Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT04660266
- Acronym / sponsor ID
- 0696-20-RMB
- Conditions
- VOD, Ultrasound Therapy; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Demonstration of liver including its size.
- Gallbladder demonstration including its width and wall thickness.
- Main portal vein width, Speed and flow direction in main portal vein.
- Evaluation of umbilical vein in the falciform ligament to check existence of flow and venous width in case it opened.
- Assessment of existence a small / medium or large amount of ascites measurement of resistance index in the main hepatic artery.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| all cohort | Other | Diagnostic Test: Liver Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 18 before a bone marrow transplantation.
Key exclusion criteria (1 listed)
- Transplanted under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver Ultrasoundliver ultrasound examination, including gray-scale and seven Doppler examination | Diagnostic test | all cohort |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Ultrasound in people with VOD and Ultrasound Therapy; Complications, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nira Beck Razi, MD (972502061204, n_beck_razi@mbam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of liver ultrasound in predicting VOD (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.