The INFUSE Trial - Intervening With Platelet Transfusions in Sepsis

Susan Smyth

Status

Withdrawn

Conditions

Thrombocytopenia

Sepsis

Treatments

Other: Saline

Biological: Platelet transfusion

Study type

Interventional

Funder types

Other

Identifiers

NCT03090919

16-0784-F6A

Details and patient eligibility

About

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. 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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).