Demographics, clinical presentation, baseline imaging, and study treatment
| . | Rivaroxaban (n = 73) . | Standard anticoagulation (n = 41) . |
|---|---|---|
| Demographics, n (%) | ||
| Male sex | 46 (63) | 23 (56) |
| Age groups | ||
| Birth to 1 y | 4 (5.5) | 5 (12) |
| 2-5 y | 22 (30) | 12 (29) |
| 6-11 y | 31 (42) | 15 (37) |
| 12-17 y | 16 (22) | 9 (22) |
| Clinical presentation, n (%) | ||
| Headache | 51 (70) | 30 (73) |
| Focal neurological deficits* | 25 (34) | 9 (22) |
| Epileptic seizure | 6 (8.2) | 6 (15) |
| Papilledema | 23 (32) | 11 (27) |
| Diplopia | 15 (21) | 7 (17) |
| Decreased vision | 8 (11) | 2 (4.9) |
| Coma† | 3 (4.1) | 1 (2.4) |
| Asymptomatic presentation CVT | 11 (15) | 7 (17) |
| CT-/MR-venography, n (%) | ||
| Parenchymal lesions | ||
| Focal edema | 9 (12) | 7 (17) |
| Intracerebral hemorrhage | 7 (10) | 3 (7.3) |
| Thrombosis location(s) | ||
| Superior sagittal sinus | 13 (18) | 8 (19.5) |
| Lateral sinus‡ | 63 (86) | 35 (85) |
| Straight sinus | 7 (9.6) | 4 (9.8) |
| Deep venous system | 5 (6.8) | 3 (7.3) |
| Cortical veins | 7 (9.6) | 2 (4.9) |
| Cavernous sinus | 4 (5.5) | 3 (7.3) |
| Jugular vein | 39 (53) | 19 (46) |
| Rivaroxaban group, n (%)§ | ||
| Tablet | 19 (26) | NA |
| Suspension | 54 (74) | NA |
| Standard anticoagulation group, n (%)§ | ||
| LMWH | NA | 35 (85) |
| LMWH followed by vitamin K antagonists | NA | 6 (15) |
| Study treatment duration, median (IQR), d | 92 (87-95) | 92 (90-95) |
| . | Rivaroxaban (n = 73) . | Standard anticoagulation (n = 41) . |
|---|---|---|
| Demographics, n (%) | ||
| Male sex | 46 (63) | 23 (56) |
| Age groups | ||
| Birth to 1 y | 4 (5.5) | 5 (12) |
| 2-5 y | 22 (30) | 12 (29) |
| 6-11 y | 31 (42) | 15 (37) |
| 12-17 y | 16 (22) | 9 (22) |
| Clinical presentation, n (%) | ||
| Headache | 51 (70) | 30 (73) |
| Focal neurological deficits* | 25 (34) | 9 (22) |
| Epileptic seizure | 6 (8.2) | 6 (15) |
| Papilledema | 23 (32) | 11 (27) |
| Diplopia | 15 (21) | 7 (17) |
| Decreased vision | 8 (11) | 2 (4.9) |
| Coma† | 3 (4.1) | 1 (2.4) |
| Asymptomatic presentation CVT | 11 (15) | 7 (17) |
| CT-/MR-venography, n (%) | ||
| Parenchymal lesions | ||
| Focal edema | 9 (12) | 7 (17) |
| Intracerebral hemorrhage | 7 (10) | 3 (7.3) |
| Thrombosis location(s) | ||
| Superior sagittal sinus | 13 (18) | 8 (19.5) |
| Lateral sinus‡ | 63 (86) | 35 (85) |
| Straight sinus | 7 (9.6) | 4 (9.8) |
| Deep venous system | 5 (6.8) | 3 (7.3) |
| Cortical veins | 7 (9.6) | 2 (4.9) |
| Cavernous sinus | 4 (5.5) | 3 (7.3) |
| Jugular vein | 39 (53) | 19 (46) |
| Rivaroxaban group, n (%)§ | ||
| Tablet | 19 (26) | NA |
| Suspension | 54 (74) | NA |
| Standard anticoagulation group, n (%)§ | ||
| LMWH | NA | 35 (85) |
| LMWH followed by vitamin K antagonists | NA | 6 (15) |
| Study treatment duration, median (IQR), d | 92 (87-95) | 92 (90-95) |
IQR interquartile range; LMWH, low-molecular-weight heparin; NA, not applicable.
Motor weakness, aphasia, sensory deficits, hemianopia.
Coma was defined as a Glasgow Coma Scale score of <9.
Composite of the sigmoid and transverse sinuses.
One child in each treatment arm also received thrombolytic therapy, both uncomplicated.