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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban-Group | Experimental | Children were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban for 3 months. |
|
| Warfarin-Group | Experimental | Children received initially low molecular weight heparin (LMWH) for 7 to 10 days followed by oral warfarin for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | Children were treated initially with low molecular weight heparin (LMWH) for 7 to 10 days followed by oral rivaroxaban for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficacy | Efficacy was considered "yes" if, after recanalization, the veins demonstrated normalization upon venography as compared to baseline. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding events | The treatment was considered 'safe', if no any bleeding event occurred within the course of treatment. | 3 months |
| Prolonged International Normalized Ratio (INR) | The treatment was considered 'safe', if INR did not exceed 3.0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Zia-Ur-Rehman, FCPS | The Children's Hospital, Lahore, Pakistan | Principal Investigator |
| Muhammad Sohail, FCPS | The Children's Hospital, Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital | Lahore | Punjab Province | 54600 | Pakistan |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Warfarin | Drug | Children received initially low molecular weight heparin (LMWH) for 7 to 10 days followed by oral warfarin for 3 months. |
|
| 3 months |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |