The INFUSE Trial - Intervening With Platelet Transfusions in Sepsis
Purpose
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.
Conditions
- Sepsis
- Thrombocytopenia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Subjects will be randomized to recieve either a platelet transfusion or a saline transfusion.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Saline |
Subjects randomized to the Saline arm will receive 250cc of physiological saline. |
|
|
Experimental Platelet transfusion |
Subjects randomized to platelet transfusion will receive a unit of platelets (~250cc in volume). |
|
Recruiting Locations
More Details
- NCT ID
- NCT03090919
- Status
- Withdrawn
- Sponsor
- Susan Smyth
Detailed 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.