Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04660266
  4. Details
NCT04660266 Clinical Trial

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

Ultrasound Therapy; Complications Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04660266
Other study ID # 0696-20-RMB
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2020
Est. completion date October 2022

Study information
Verified date December 2020
Source Rambam Health Care Campus
Contact Nira Beck Razi, MD
Phone 972502061204
Email n_beck_razi@mbam.health.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date October 2022
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients over the age of 18 before a bone marrow transplantation. Exclusion Criteria: - Transplanted under 18 years of age.

Study Design

Related Conditions & MeSH terms

  • Ultrasound Therapy; Complications
  • VOD

Intervention

Diagnostic Test:
• Liver Ultrasound
liver ultrasound examination, including gray-scale and seven Doppler examination

Locations
Country Name City State
Israel Rambam Medical Center Haifa Israek

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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		 21 days
See also
  Status Clinical Trial Phase
Recruiting NCT05778279 - Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies
Completed NCT04659395 - How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block N/A
Recruiting NCT04438265 - Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment
Recruiting NCT04952220 - Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee
Completed NCT04149041 - The Applications of Point-of-care Ultrasound in ED Unselected, Non-critical Patients
Completed NCT06000215 - Credibility of Ultrasound Detection of Female Genital Prolapse Mesh
Completed NCT04581616 - The Effect of Ultrasound-guided Erector Spinae Block and Intraoperative Intercostal Nerve Block on Postoperative Analgesia in Thoracic Surgery N/A
Completed NCT05151432 - Effect of Pulsed Electromagnetic Field and Pulsed Ultrasound in Treating Knee Osteoarthritis N/A
Completed NCT04674852 - Mayo Designed Soft Tissue Ultrasound-Detectable Marker N/A
Recruiting NCT05627830 - Ultrasound Guided Versus Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. N/A
Completed NCT04382430 - Ultrasound Axillary Vein Access: Evaluation of Learning Curve for an Alternative Approach to Cardiac Device Implantation N/A
Completed NCT04917406 - Effect of Iontophoresis vs. Ultrasound and Iontophoresis in Plantar Fasciitis". Plantar Fasciitis" N/A
Not yet recruiting NCT04862182 - Intrapartum Ultrasound in Predicting Mode of Delivery
Completed NCT03122119 - Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint Phase 4
Completed NCT04753450 - Correlation of Muscle Ultrasound Measures (2D and 3D) With Biphotonic X-ray Absorptiometry in Oldest Old Patients.
Completed NCT03676699 - Lung Ultrasound in Detection of Extravascular Lung Water in Septic Patients.
Recruiting NCT03144895 - Arterial Catheterization by Ultrasound N/A
Recruiting NCT05535816 - Accuracy of Ultrasound for Detecting Residual Fragments During RIRS N/A
Recruiting NCT05769517 - PREDICTION OF GERMLINE BRCA 1/2 GENES FROM HEALTHY OVARIES
Completed NCT05927285 - Effect on Kidney Function Recovery Guiding Decongestion With VExUS in Patients With Cardiorenal Syndrome 1 N/A

External Links