Evaluation of efficacy and safety of dabigatran(paradxa) in pediatric thromboembolism: a pilot study
Design
clinical trial including two groups receiving Warfarin and oral Dabigatran, With parallel groups, Open lable, notrandomized
Settings and conduct
This study is grounded in the field of thromboembolie in Arak city. After getting informed consent from the parents, demographic information will be recorded. Then the patients divided into two groups receiving warfarin and Dabigatran (for 6 months) not randomly. The incidence of bleeding, recurrent thromboembolism, and kidney-liver function monitored during drug use.
Participants/Inclusion and exclusion criteria
1.Informed consent
2.Children under 18 years
3.Affected by Thromboembolism
Intervention groups
Intervention group: Enoxaparin is given at a dose of 1 mg / kg every 12 hours with Dabigatran(Pradaxa) 220 mg / m2 in a divided doses In the first five days of treatment. Then, enoxaparin is discontinued and Dabigatran(Pradaxa) will continue for 6 months
Control group: Enoxaparin is given at a dose of 12 mg / kg every 12 hours with warfarin 0.2 mg / kg once a day In the first five days of treatment. Then, enoxaparin is discontinued and warfarin will continue with an INR of 2-3 for 6 months.
Main outcome variables
incidence of bleeding, recurrent thromboembolism, and kidney-liver function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180711040431N1
Registration date:2018-11-23, 1397/09/02
Registration timing:registered_while_recruiting
Last update:2018-11-23, 1397/09/02
Update count:0
Registration date
2018-11-23, 1397/09/02
Registrant information
Name
roghaieh rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3322 0099
Email address
r.rahimi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-10, 1397/04/19
Expected recruitment end date
2019-07-10, 1398/04/19
Actual recruitment start date
2018-07-10, 1397/04/19
Actual recruitment end date
2019-07-10, 1398/04/19
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of dabigatran(paradxa) in pediatric thromboembolism: a pilot study
Public title
efficacy and safety of dabigatran(paradxa) in pediatric thromboembolism Referring to Amir Kabir Hospital in Arak
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Children under 18 years
Affected by Thromboembolism
Exclusion criteria:
Having other blood disorders
Age
From 1 year old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Amir kabir hospital, Khoram AVe, Arak Town
City
Arak
Province
Markazi
Postal code
38146-7-5999
Approval date
2018-07-10, 1397/04/19
Ethics committee reference number
IR.ARAKMU.REC.1397.082
Health conditions studied
1
Description of health condition studied
children-thromboemboli
ICD-10 code
I74.8
ICD-10 code description
Embolism and thrombosis of other arteries
Primary outcomes
1
Description
bleeding frequency
Timepoint
In the first month, each week and then every month, Primary outcomes are checked.
Method of measurement
Interview with patient or family
2
Description
recurrent thromboembolism
Timepoint
In the first month, each week and then every month, they are checked.
Method of measurement
History and clinical examination and, if needed, imaging
3
Description
liver and kidney function during drug use
Timepoint
In the first month, each week and then every month, they are checked.
Method of measurement
History and clinical examination and, if needed, Liver Function Tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : (received oral Dabigatran), Enoxaparin is given at a dose of 1 mg / kg every 12 hours with Dabigatran(Pradaxa) 220 mg / m2 in a divided doses In the first five days of treatment. Then, enoxaparin is discontinued and Dabigatran(Pradaxa) will continue for 6 months
Category
Treatment - Drugs
2
Description
Control group: Enoxaparin is given at a dose of 12 mg / kg every 12 hours with warfarin 0.2 mg / kg once a day In the first five days of treatment. Then, enoxaparin is discontinued and warfarin will continue with an INR of 2-3 for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir kabir Hospital
Full name of responsible person
Dr aziz eghbali
Street address
Amir kabir Hospital, Khoram Ave
City
arak
Province
Markazi
Postal code
38146-7-5999
Phone
+98 86 3322 0099
Email
aziz_eghbali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Aziz eghbali
Street address
Amir kabir Hospital, Khoram Ave
City
arak
Province
Markazi
Postal code
38146-7-5999
Phone
+98 86 3322 0099
Email
aziz_eghbali@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Aziz eghbali
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amir kabir Hospital, Khoram Ave
City
arak
Province
Markazi
Postal code
38146-7-5999
Phone
+98 86 3322 0099
Email
aziz_eghbali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
aziz eghbali
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amir kabir Hospital, Khoram Ave
City
arak
Province
Markazi
Postal code
38146-7-5999
Phone
+98 86 3322 0099
Email
aziz_eghbali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
roghaieh rahimi afzal
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Amir kabir Hospital, Khoram Ave
City
arak
Province
Markazi
Postal code
38146-7-5999
Phone
+98 86 3322 0099
Email
r.rahimi@arakmu.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
The only data analysis is available to people
When the data will become available and for how long
Get started since 1399
To whom data/document is available
It's free to the public
Under which criteria data/document could be used
It's free to the public
From where data/document is obtainable
aziz_eghbali@yahoo.com
What processes are involved for a request to access data/document