efficacy and safety of dabigatran(paradxa) in pediatric thromboembolism Referring to Amir Kabir Hospital in Arak

Evaluation of efficacy and safety of dabigatran(paradxa) in pediatric thromboembolism: a pilot study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180711040431N1

Enrollment

Registered

2018-11-23

Start date

2018-07-10

Completion date

Unknown

Last updated

2019-01-14

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

Conditions

children-thromboemboli. Embolism and thrombosis of other arteries

Interventions

Intervention 1: 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 day

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion criteria

Inclusion criteria: Informed consent Children under 18 years Affected by Thromboembolism

Exclusion criteria

Exclusion criteria: Having other blood disorders

Design outcomes

Primary

Measure	Time frame
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.;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.;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.	—

Measure

Time frame

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.;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.;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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAziz eghbali

Arak University of Medical Sciences

aziz_eghbali@yahoo.com+98 86 3322 0099

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026