Recombinant human activated protein C is a natural anticoagulant that may have some benefit for patients with severe sepsis. A serious side effect of therapy is the occurrence of severe bleeding. Certain conditions may contraindicate therapy because of the high risk of life threatening hemorrhage, although this must be balanced against the poor prognosis of overwhelming sepsis.


Absolute contraindications:

(1) active internal hemorrhage

(2) recent hemorrhagic stroke, within past 3 months

(3) recent intracranial or intraspinal surgery, within past 2 months

(4) recent severe head trauma, within past 2 months

(5) trauma with an increased risk of life-threatening bleeding

(6) presence of epidural catheter

(7) intracranial neoplasm or mass lesion

(8) evidence of cerebral herniation


Relative contraindications:

(1) concurrent therapy with heparin (>= 15 units per kg per hour)

(2) INR > 3.0

(3) platelet count < 30,000 per µL (even if higher after platelet transfusion)

(4) recent gastrointestinal bleeding, within past 6 weeks

(5) recent thrombolytic therapy, within 3 days

(6) recent oral anticoagulant therapy, within 7 days

(7) recent glycoprotein IIb/IIIa inhibitor therapy, within 7 days

(8) recent administration of aspirin (> 650 mg per day) or other platelet inhibitor, within 7 days

(9) recent ischemic stroke, within 3 months

(10) intracranial arteriovenous malformation

(11) intracranial aneurysm

(12) known bleeding diathesis

(13) any condition in which bleeding represents a significant hazard

(14) any condition in which bleeding may be difficult to manage because of its location


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