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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

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

ArmDescriptionAssigned Intervention
Placebo Comparator
Saline
Subjects randomized to the Saline arm will receive 250cc of physiological saline.
  • Other: Saline
Experimental
Platelet transfusion
Subjects randomized to platelet transfusion will receive a unit of platelets (~250cc in volume).
  • Biological: Platelet transfusion

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Susan Smyth, MD
859-323-2274
ssmyt2@email.uky.edu

More Details

NCT ID
NCT03090919
Status
Recruiting
Sponsor
Susan Smyth

Study Contact

Susan S Smyth, MD PhD
859-323-2274
susan.smyth@uky.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.