The INFUSE Trial - Intervening With Platelet Transfusions in Sepsis

Sepsis is life-threatening and dysregulated response to infection that results in endothelial
activation and dysfunction that leads to systemic microvascular leak and multiple-organ
failure. Emerging evidence indicates that platelets occupy a central role in maintaining the
balance between vascular health and the response to environmental changes and vascular
injury. Platelets are essential for vascular development and required for normal endothelial
integrity. Platelets also function at the interface between thrombosis and inflammation. This
study will identify patients that have sepsis with thrombocytopenia and randomize them to
receive a unit of platelets or an equivalent volume of saline.

Our overall hypotheis is that normal platelet function is required to maintain vascular
integrity and can be at least partially restored over the first 24 hours by platelet
transfusion in septic patients with thrombocytopenia.

Inclusion Criteria

- Provision of informed consent prior to any study specific procedures

- Female and/or male, age >18 years

- Diagnosis of sepsis based on the Third International Consensus Definitions for Sepsis
and Septic Shock

- Platelet count ≤ 50,000/μL

Exclusion Criteria

- Active major bleeding requiring blood transfusion

- Other causes of thrombocytopenia such as idiopathic thrombocytopenic purpura, high
clinical suspicion for heparin-induced thrombocytopenia (or other form of consumptive
coagulopathy).