Evaluation of efficacy and adverse effects of rivaroxaban in children with central venous catheter thrombosis
Design
Non-randomized clinical trial without control group
Phase 1-2 in 20 patients enrolled between March 2024 and March 2025 and followed for 1 months.
Settings and conduct
In the children's special care department at Tehran Children's Medical Center Hospital, the patient must have been treated with heparin or enoxaparin for at least 5 to 9 days. Then Rivaroxaban drug is prescribed with a dose (according to the table) and continues for 30 days. At the end of 30 days, a compression Doppler ultrasound is performed again. Blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 2-8 years old diagnosed with CVC-VTE by doppler US after receiving at least 5 days of heparin or enoxaparin
Exclusion criteria: Age under 2 years, Active bleeding, Comorbidity
Intervention groups
Pediatric patients aged 2 to 18 years with obvious thrombosis with a central venous catheter confirmed by compressive Doppler ultrasonography will be treated as follows: the patient must have been treated with heparin or enoxaparin for at least 5 to 9 days. Then Rivaroxaban drug is prescribed with a dose (according to the table) and continues for 30 days. At the end of 30 days, a compression Doppler ultrasound is performed again.
Main outcome variables
Efficacy and adverse effects of the drug
General information
Reason for update
Acronym
Rivaroxaban trial
IRCT registration information
IRCT registration number:IRCT20231021059793N1
Registration date:2024-02-28, 1402/12/09
Registration timing:prospective
Last update:2024-02-28, 1402/12/09
Update count:0
Registration date
2024-02-28, 1402/12/09
Registrant information
Name
Azadeh Kiumarsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8857 9492
Email address
akiumarsi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and adverse effects of rivaroxaban in children with central venous catheter thrombosis
Public title
Effect of Rivaroxaban in Thrombosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 2-18 years old
CVC-VTE diagnosed by US Doppler
Five days received enoxaparin or heparin
Exclusion criteria:
Active bleeding
History of anaphylaxis to rivaroxaban
Usage of other anticoagulant drugs including ASA, platelet inhibitors, NSAID, Fibrinolytic, SSRI and SNRI
Acutely ill patients with increased risk of bleeding including bronchiectasis, pulmonary cavitation, pulmonary hemorrhage, active cancer, recent HSCT in last 3 months, active GI ulcer or recent GI bleeding in the last 3 months, Liver disease with coagulopathy
Patients needing spinal anesthesia or LP
Creatinine clearance lower than 30 ml/min
Platelet count lower than 75 X 109
Dialysis catheter or artificial heart leaflet
Unstable hemodynamic
Age
From 2 years old to 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Children medical hospital, Gharib st, Keshavarz Blv., Tehran
City
Tehran
Province
Tehran
Postal code
14676783815
Approval date
2023-09-17, 1402/06/26
Ethics committee reference number
IR.TUMS.CHMC.REC.1402.109
Health conditions studied
1
Description of health condition studied
Thrombosis
ICD-10 code
I82
ICD-10 code description
Other venous embolism and thrombosis
Primary outcomes
1
Description
Occurrence of thrombosis
Timepoint
Efficacy of Rivaroxaban is evaluated by Doppler ultrasound conducted 30 days after drug administration.
Method of measurement
Follow-up ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: children with CVC-VTE that would receive 5 days of Enoxaparin and then 30 days of Rivaroxaban.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children medical center
Full name of responsible person
Azadeh Kiumarsi
Street address
Children's Medical Center Hospital, Gharib street, Keshavarz Blvd, Tehran.
City
Tehran
Province
Tehran
Postal code
1467683815
Phone
+98 21 6147 0000
Email
Akiumarsi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
Research and Technology Vice-Chancellor, 6th floor., Central Organization of the University, Corner of Quds Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1467683815
Phone
+98 21 6147 0000
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Kiumarsi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children medical hospital, Gharib st, Keshavarz Blv., Tehran
City
Tehran
Province
Tehran
Postal code
1467683815
Phone
+98 21 4761 0000
Email
akiumarsi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Kiumarsi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children medical hospital, Gharib st, Keshavarz Blv., Tehran
City
Tehran
Province
Tehran
Postal code
1467683815
Phone
+98 21 8857 9492
Email
akiumarsi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Kiumarsi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children medical hospital, Gharib st, Keshavarz Blv., Tehran
City
Tehran
Province
Tehran
Postal code
1467683815
Phone
+98 21 8857 9492
Email
akiumarsi@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participant data sets are to be shared
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
No other criteria is needed
From where data/document is obtainable
Azadeh Kiumars, Children medical hospital
What processes are involved for a request to access data/document