Expanded WHO bleeding scale used for the hemostatic primary end point
. | Bleeding grade . | . | |
|---|---|---|---|
| Organ system . | 1 . | 2 . | |
| Mucocutaneous | |||
| Epistaxis | < 1 h in duration | > 1 h in duration | |
| Oropharyngeal | < 1 h in duration | > 1 h in duration | |
| Petechiae/purpura | Localized petechiae of skin or oral mucosa; purpura < 1-inch diameter | Purpura > 1-inch diameter; generalized petechiae or purpura | |
| Gastrointestinal | |||
| Melena | NA | Melanotic stool with positive occult blood | |
| Rectal bleeding/hematochezia | Occult blood in stool; no visible blood | Visible blood in stool | |
| Hematemesis | NA | Occult or visible blood in vomit or gastric contents | |
| Genitourinary | |||
| Hematuria | < 1 + (slight, trace, small) blood in urine | ≥ 2 + (moderate) | |
| Vaginal bleeding, abnormal | Spotting; < 2 saturated pads/d | > 2 saturated pads/d | |
| Bronchopulmonary | NA | Hemoptysis; blood-tinged sputum; bloody bronchopulmonary lavage | |
| Musculoskeletal and soft tissue | NA | Spontaneous hematoma; any joint bleed | |
| Body cavity (pleural, peritoneal, pericardial, retroperitoneal) | NA | RBCs on microscopic examination of any body fluid | |
| Central nervous system | NA | Retinal bleeding without visual impairment | |
| Invasive sites | NA | Any bleeding around a catheter, venipuncture site, or other invasive or surgical site | |
. | Bleeding grade . | . | |
|---|---|---|---|
| Organ system . | 1 . | 2 . | |
| Mucocutaneous | |||
| Epistaxis | < 1 h in duration | > 1 h in duration | |
| Oropharyngeal | < 1 h in duration | > 1 h in duration | |
| Petechiae/purpura | Localized petechiae of skin or oral mucosa; purpura < 1-inch diameter | Purpura > 1-inch diameter; generalized petechiae or purpura | |
| Gastrointestinal | |||
| Melena | NA | Melanotic stool with positive occult blood | |
| Rectal bleeding/hematochezia | Occult blood in stool; no visible blood | Visible blood in stool | |
| Hematemesis | NA | Occult or visible blood in vomit or gastric contents | |
| Genitourinary | |||
| Hematuria | < 1 + (slight, trace, small) blood in urine | ≥ 2 + (moderate) | |
| Vaginal bleeding, abnormal | Spotting; < 2 saturated pads/d | > 2 saturated pads/d | |
| Bronchopulmonary | NA | Hemoptysis; blood-tinged sputum; bloody bronchopulmonary lavage | |
| Musculoskeletal and soft tissue | NA | Spontaneous hematoma; any joint bleed | |
| Body cavity (pleural, peritoneal, pericardial, retroperitoneal) | NA | RBCs on microscopic examination of any body fluid | |
| Central nervous system | NA | Retinal bleeding without visual impairment | |
| Invasive sites | NA | Any bleeding around a catheter, venipuncture site, or other invasive or surgical site | |
Grade 3 bleeding requires RBC transfusion; grade 3 body cavity bleeding is grossly bloody body fluid; grade 3 central nervous system (CNS) bleeding is bleeding on computed tomography or magnetic resonance imaging scan without clinical consequence. Grade 4 bleeding is associated with hemodynamic instability (hypotension; > 30 mm Hg decrease in systolic or diastolic blood pressure) or fatal bleeding; grade 4 musculoskeletal bleeding is associated with a permanent debilitating joint change; grade 4 CNS bleeding is CNS bleeding with neurologic symptoms and signs, or retinal bleeding with visual impairment (field deficit). Expanded scale is based on WHO bleeding scale from Miller et al.29 NA indicates not applicable.