The INFUSE Trial - Intervening With Platelet Transfusions in Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-03

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sepsis Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized to recieve either a platelet transfusion or a saline transfusion.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Saline

Subjects randomized to the Saline arm will receive 250cc of physiological saline.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Platelet transfusion

Subjects randomized to platelet transfusion will receive a unit of platelets (\~250cc in volume).

Group Type EXPERIMENTAL

Platelet transfusion

Intervention Type BIOLOGICAL

Interventions

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Platelet transfusion

Intervention Type BIOLOGICAL

Saline

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No