Clinical impact of bleeding
| Clinical impact . | Major bleeding, n/N (%) . | Clinically relevant nonmajor bleeding . |
|---|---|---|
| Location∗ | ||
| Intracranial | 15/100 (15) | N/A |
| Intraspinal | 1/100 (1) | N/A |
| Intraocular | 2/100 (2) | N/A |
| Retroperitoneal | 4/100 (4) | N/A |
| Intraarticular | 4/100 (4) | N/A |
| Intramuscular with compartment syndrome | 1/100 (1) | N/A |
| Intramuscular | 16/100 (16) | 5/125 (4) |
| Gastrointestinal† | 34/100 (34) | 21/125 (17) |
| Cutaneous/subcutaneous | 15/100 (15) | 51/125 (41) |
| Hemoptysis | 1/100 (1) | 3/125 (2) |
| Urogenital | 11/100 (11) | 22/125 (18) |
| Epistaxis | 2/100 (2) | 21/125 (17) |
| Unknown | 1/100 (1) | 3/125 (2) |
| Management | ||
| Transfusion of ≥2 units of packed red blood cells | 47/100 (47) | N/A |
| Administration of fresh frozen plasma or prothrombin complex concentrates | 12/100 (12) | 2/125 (2) |
| Vena cava filter insertion | 7/100 (7) | 0/125 (0) |
| Surgical hemostasis | 18/100 (18) | 14/125 (11) |
| Definite discontinuation of anticoagulation‡ | 19/100 (19) | 8/125 (6) |
| Outcomes | ||
| Need for hospital admission§ | 26/33 (79) | 14/91 (15) |
| Bleeding-related death‖ | 6/100 (6) | N/A |
| Clinical impact . | Major bleeding, n/N (%) . | Clinically relevant nonmajor bleeding . |
|---|---|---|
| Location∗ | ||
| Intracranial | 15/100 (15) | N/A |
| Intraspinal | 1/100 (1) | N/A |
| Intraocular | 2/100 (2) | N/A |
| Retroperitoneal | 4/100 (4) | N/A |
| Intraarticular | 4/100 (4) | N/A |
| Intramuscular with compartment syndrome | 1/100 (1) | N/A |
| Intramuscular | 16/100 (16) | 5/125 (4) |
| Gastrointestinal† | 34/100 (34) | 21/125 (17) |
| Cutaneous/subcutaneous | 15/100 (15) | 51/125 (41) |
| Hemoptysis | 1/100 (1) | 3/125 (2) |
| Urogenital | 11/100 (11) | 22/125 (18) |
| Epistaxis | 2/100 (2) | 21/125 (17) |
| Unknown | 1/100 (1) | 3/125 (2) |
| Management | ||
| Transfusion of ≥2 units of packed red blood cells | 47/100 (47) | N/A |
| Administration of fresh frozen plasma or prothrombin complex concentrates | 12/100 (12) | 2/125 (2) |
| Vena cava filter insertion | 7/100 (7) | 0/125 (0) |
| Surgical hemostasis | 18/100 (18) | 14/125 (11) |
| Definite discontinuation of anticoagulation‡ | 19/100 (19) | 8/125 (6) |
| Outcomes | ||
| Need for hospital admission§ | 26/33 (79) | 14/91 (15) |
| Bleeding-related death‖ | 6/100 (6) | N/A |
N/A, not applicable.
Sum of percentages exceeds 100% because several bleeding locations were possible.
Hematemesis, melena, or hematochezia.
Anticoagulation was stopped at the time of bleeding and not resumed within 14 days.
Subgroup of 124 patients in whom bleeding occurred in the outpatient setting.
Overall, 4 intracranial, 1 retroperitoneal, and 1 intramuscular bleed were fatal.