Demographics, clinical presentation, and study treatment at baseline
| . | Age birth to <2 y* (n = 36) . | Age 2 to 5 y (n = 26) . | Age 6 to 11 y (n = 24) . | Age 12 to 17 y (n = 40) . | Total (N = 126) . |
|---|---|---|---|---|---|
| Demographics | |||||
| Male sex, n (%) | 22 (61) | 10 (38) | 15 (63) | 23 (58) | 70 (56) |
| Body weight, mean (SD), kg | 6.7 (3.1) | 14.6 (3.3) | 31.3 (7.5) | 55.7 (14.3) | 28.5 (22.2) |
| Proportion CVC-VTE of the entire Einstein-Jr population, n/N (%)† | 36/54 (67) | 26/69 (38) | 24/101 (24) | 40/276 (14) | 126/500 (25) |
| Clinical presentation of venous thrombosis, n (%) | |||||
| Jugular vein | 13 (36) | 9 (35) | 8 (33) | 11 (28) | 41 (33) |
| Upper extremity‡ | 0 | 4 (15) | 7 (29) | 24 (60) | 35 (28) |
| Right heart | 1 (2.8) | 3 (12) | 4 (17) | 3 (7.5) | 11 (8.7) |
| Caval vein | 1 (2.8) | 0 | 0 | 1 (2.5) | 2 (1.6) |
| Portal vein | 0 | 0 | 1 (4.2) | 0 | 1 (0.8) |
| Lower extremity | 21 (58) | 10 (38) | 4 (17) | 1 (2.5) | 36 (29) |
| Asymptomatic presentation CVC-VTE | 15 (42) | 14 (54) | 10 (42) | 11 (28) | 50 (40) |
| Time course of CVC-VTE, n (%) | |||||
| Acute (0-14 d) | 25 (69) | 14 (54) | 13 (54) | 19 (48) | 71 (56) |
| Subacute (15-28 d) | 6 (17) | 3 (11) | 3 (13) | 6 (15) | 18 (14) |
| Chronic (>28 d) | 5 (14) | 9 (35) | 8 (33) | 15 (37) | 37 (29) |
| Etiology of index VTE, n (%) | |||||
| Transient risk factor (apart from the CVC) | 13 (36) | 10 (38) | 10 (42) | 16 (40) | 49 (39) |
| Persistent ± transient risk factor | 23 (64) | 16 (62) | 14 (58) | 24 (60) | 77 (61) |
| Type of risk factor, n (%) | |||||
| Major trauma/surgery | 15 (42) | 9 (35) | 7 (29) | 9 (23) | 40 (32) |
| Major infectious disease | 11 (31) | 7 (27) | 7 (29) | 9 (23) | 34 (27) |
| Use of estrogens or progestins | NA | NA | NA | 4 (24)§ | NA |
| Major organ disease | 22 (61) | 11 (42) | 7 (29) | 7 (18) | 47 (37) |
| Cardiac | 20 (56) | 9 (35) | 5 (21) | 4 (10) | 38 (30) |
| Gastrointestinal | 0 | 0 | 0 | 2 (5) | 2 (1.6) |
| Neurological | 0 | 2 (7.7) | 0 | 0 | 2 (1.6) |
| Renal | 2 (5.6) | 0 | 2 (8.3) | 1 (2.5) | 5 (40) |
| Active cancer|| | 1 (2.8) | 7 (27) | 7 (29) | 16 (40) | 31 (25) |
| Hematologic cancer | 1 (2.8) | 5 (19) | 3 (13) | 11 (28) | 20 (16) |
| Solid tumor | 0 | 2 (7.7) | 4 (17) | 5 (21) | 11 (8.7) |
| Known inherited thrombophilia¶ | 1 (2.8) | 0 | 0 | 0 | 1 (0.8) |
| Study treatment, n (%) | |||||
| Initial therapy with UFH only | 10 (28) | 4 (15) | 1 (4.2) | 3 (7.5) | 11 (8.7) |
| Initial therapy with LMWH | 26 (72) | 22 (85) | 23 (96) | 37 (93) | 115 (91) |
| Rivaroxaban group, n (%)** | |||||
| Tablet | 0 | 0 | 5 (31.2) | 16 (57.1) | 21 (24.1) |
| Suspension | 25 (100.0) | 18 (100.0) | 11 (68.8) | 12 (42.9) | 66 (75.9) |
| Standard anticoagulation group, n (%) | |||||
| LMWH | 8 (80.0) | 5 (71.4) | 7 (87.5) | 9 (81.8) | 29 (80.6) |
| LMWH followed by vitamin K antagonists | 2 (20.0) | 2 (28.6) | 1 (12.5) | 2 (18.2) | 7 (19.4) |
| . | Age birth to <2 y* (n = 36) . | Age 2 to 5 y (n = 26) . | Age 6 to 11 y (n = 24) . | Age 12 to 17 y (n = 40) . | Total (N = 126) . |
|---|---|---|---|---|---|
| Demographics | |||||
| Male sex, n (%) | 22 (61) | 10 (38) | 15 (63) | 23 (58) | 70 (56) |
| Body weight, mean (SD), kg | 6.7 (3.1) | 14.6 (3.3) | 31.3 (7.5) | 55.7 (14.3) | 28.5 (22.2) |
| Proportion CVC-VTE of the entire Einstein-Jr population, n/N (%)† | 36/54 (67) | 26/69 (38) | 24/101 (24) | 40/276 (14) | 126/500 (25) |
| Clinical presentation of venous thrombosis, n (%) | |||||
| Jugular vein | 13 (36) | 9 (35) | 8 (33) | 11 (28) | 41 (33) |
| Upper extremity‡ | 0 | 4 (15) | 7 (29) | 24 (60) | 35 (28) |
| Right heart | 1 (2.8) | 3 (12) | 4 (17) | 3 (7.5) | 11 (8.7) |
| Caval vein | 1 (2.8) | 0 | 0 | 1 (2.5) | 2 (1.6) |
| Portal vein | 0 | 0 | 1 (4.2) | 0 | 1 (0.8) |
| Lower extremity | 21 (58) | 10 (38) | 4 (17) | 1 (2.5) | 36 (29) |
| Asymptomatic presentation CVC-VTE | 15 (42) | 14 (54) | 10 (42) | 11 (28) | 50 (40) |
| Time course of CVC-VTE, n (%) | |||||
| Acute (0-14 d) | 25 (69) | 14 (54) | 13 (54) | 19 (48) | 71 (56) |
| Subacute (15-28 d) | 6 (17) | 3 (11) | 3 (13) | 6 (15) | 18 (14) |
| Chronic (>28 d) | 5 (14) | 9 (35) | 8 (33) | 15 (37) | 37 (29) |
| Etiology of index VTE, n (%) | |||||
| Transient risk factor (apart from the CVC) | 13 (36) | 10 (38) | 10 (42) | 16 (40) | 49 (39) |
| Persistent ± transient risk factor | 23 (64) | 16 (62) | 14 (58) | 24 (60) | 77 (61) |
| Type of risk factor, n (%) | |||||
| Major trauma/surgery | 15 (42) | 9 (35) | 7 (29) | 9 (23) | 40 (32) |
| Major infectious disease | 11 (31) | 7 (27) | 7 (29) | 9 (23) | 34 (27) |
| Use of estrogens or progestins | NA | NA | NA | 4 (24)§ | NA |
| Major organ disease | 22 (61) | 11 (42) | 7 (29) | 7 (18) | 47 (37) |
| Cardiac | 20 (56) | 9 (35) | 5 (21) | 4 (10) | 38 (30) |
| Gastrointestinal | 0 | 0 | 0 | 2 (5) | 2 (1.6) |
| Neurological | 0 | 2 (7.7) | 0 | 0 | 2 (1.6) |
| Renal | 2 (5.6) | 0 | 2 (8.3) | 1 (2.5) | 5 (40) |
| Active cancer|| | 1 (2.8) | 7 (27) | 7 (29) | 16 (40) | 31 (25) |
| Hematologic cancer | 1 (2.8) | 5 (19) | 3 (13) | 11 (28) | 20 (16) |
| Solid tumor | 0 | 2 (7.7) | 4 (17) | 5 (21) | 11 (8.7) |
| Known inherited thrombophilia¶ | 1 (2.8) | 0 | 0 | 0 | 1 (0.8) |
| Study treatment, n (%) | |||||
| Initial therapy with UFH only | 10 (28) | 4 (15) | 1 (4.2) | 3 (7.5) | 11 (8.7) |
| Initial therapy with LMWH | 26 (72) | 22 (85) | 23 (96) | 37 (93) | 115 (91) |
| Rivaroxaban group, n (%)** | |||||
| Tablet | 0 | 0 | 5 (31.2) | 16 (57.1) | 21 (24.1) |
| Suspension | 25 (100.0) | 18 (100.0) | 11 (68.8) | 12 (42.9) | 66 (75.9) |
| Standard anticoagulation group, n (%) | |||||
| LMWH | 8 (80.0) | 5 (71.4) | 7 (87.5) | 9 (81.8) | 29 (80.6) |
| LMWH followed by vitamin K antagonists | 2 (20.0) | 2 (28.6) | 1 (12.5) | 2 (18.2) | 7 (19.4) |
NA, not applicable; SD, standard deviation.
Children aged birth to <0.5 years, n = 1; children aged 0.5 to 1 year, n = 8.
The EINSTEIN-Jr study included 500 children with various types of VTE.17
Including axillary and subclavian vein.
Active cancer was defined as presence of metastases, or recently (<6 months) diagnosed or treated.
Antithrombin deficiency (heterozygous).
Three children allocated to rivaroxaban did not receive study medication.
Calculated for 17 girls aged 12 to 17 years.