Table 2.
Bleeding Risk Criteria in the PROWESS Study and in the Product Label for Activated Protein C
| PROWESS Exclusion Criteria | Xigris Product Label |
|---|---|
| Active internal bleeding | Contraindication |
| Hemorrhagic stroke within 3 months | Contraindication |
| Intracranial/intraspinal surgery or severe head trauma within 2 months | Contraindication |
| Trauma with increased risk of life-threatening bleeding | Contraindication |
| Presence of an epidural catheter | Contraindication |
| Intracranial neoplasm or mass lesion or evidence of cerebral herniation | Contraindication |
| Concurrent therapeutic heparin to treat an active or thrombotic event | Precaution |
| Platelet count below 30,000/mm3 | Precaution |
| Prothrombin time–INR above 3 | Precaution |
| Gastrointestinal bleeding within 6 weeks | Precaution |
| Systemic thrombolytic therapy within 3 days | Precaution |
| Oral anticoagulants or glycoprotein IIb/IIIa inhibitors within 7 days | Precaution |
| Aspirin (> 650 mg/day) or other platelet inhibitor within 7 days | Precaution |
| Ischemic stroke within 3 months | Precaution |
| Intracranial arteriovenous malformation or aneurysm | Precaution |
| Known bleeding diathesis | Precaution |
| Chronic severe hepatic disease | Precaution |
| Any other condition in which bleeding constitutes a significant hazard or would be very difficult to manage because of its location | Precaution |
INR = International Normalized Ratio; PROWESS = Protein C Worldwide Evaluation in Severe Sepsis.