Cerebrosinovenous Thrombosis
Conditions
Brief summary
The study seeks to fill the gaps regarding safety and efficacy of rivaroxaban and standard anticoagulant. therefore the current study was planned with the aim to determine the safety and efficacy of rivaroxaban and standard anticoagulant in the treatment of cerebrosinovenous thrombosis (CSVT).
Detailed description
There have not been any randomized controlled trials in the country to demonstrate the efficacy, safety and outcome after the oral use of rivaroxaban in pediatric population and establish its protocol with body weight adjusted dosages in children. The findings of this study would not only add to the local data but also be of great interest to physicians and CSVT patients if an anticoagulant were found to have predictable effects and no need for therapeutic INR monitoring.
Interventions
DRUGRivaroxaban
Children were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban for 3 months.
DRUGWarfarin
Children received initially low molecular weight heparin (LMWH) for 7 to 10 days followed by oral warfarin for 3 months.
Sponsors
Muhammad Aamir Latif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Any gender * Aged 2 months to 18 years * Patients presenting with CSVT evident by computed tomography (CT) or magnetic resonance venography (MRV).
Exclusion criteria
* Patients having active bleeding or having high risk of bleeding * Estimated glomerular filtration rate \< 30 milliliter/minute per 1.73 m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficacy | 3 months | Efficacy was considered "yes" if, after recanalization, the veins demonstrated normalization upon venography as compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding events | 3 months | The treatment was considered 'safe', if no any bleeding event occurred within the course of treatment. |
| Prolonged International Normalized Ratio (INR) | 3 months | The treatment was considered 'safe', if INR did not exceed 3.0. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORMuhammad Zia-Ur-Rehman, FCPS
The Children's Hospital, Lahore, Pakistan
PRINCIPAL_INVESTIGATORMuhammad Sohail, FCPS
The Children's Hospital, Lahore
Outcome results
None listed