The INFUSE Trial - Intervening With Platelet Transfusions in Sepsis

Not Applicable

Withdrawn

• Conditions: Sepsis; Thrombocytopenia
• Interventions: Biological: Platelet transfusion; Other: Saline

• Registration Number: NCT03090919
• Lead Sponsor: Susan Smyth

Brief Summary

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.

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.

Study Timeline

• Study Start: 2017-01-03
• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-27
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet transfusion	Platelet transfusion	Subjects randomized to platelet transfusion will receive a unit of platelets (\~250cc in volume).
Saline	Saline	Subjects randomized to the Saline arm will receive 250cc of physiological saline.

Primary Outcome Measures

Name	Time	Method
Biomarkers for vascular integrity	24 Hours	The ratio of Angiopoietin-2 to Angiopoietin-1 is used as a measurement of vascular integrity. We will determine the change in this ratio by measuring Angiopoietin-2 (pg/mL) and Angiopoietin-1 (pg/mL) at baseline (before infusion) and 24 hours after infusion and compare between the patients receiving a unit of platelets versus the patients receiving saline.
Biomarkers for inflammation	24 Hours	IL-6 and TNF-alpha are commonly measured as biomarkers for inflammation. We will measure the change in concentrations (pg/mL) of IL-6 and TNF-alpha between baseline and 24 hours and compare between the population receiving a unit of platelets versus the population receiving saline.

Secondary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events	30 days	Each subject will be monitored for serious adverse events (e.g. death, rehospitalization) for 30 days following the platelet/saline transfusion. Outcome data will be compared between the platelet transfusion arm and the placebo arm.
Transfusion effects on cytokines	72 Hours	Changes in cytokine (e.g. IL-1beta) concentrations (pg/mL) will be measured at baseline (prior to transfusion) and up to 72 hours after transfusion and compared between the population receiving a unit of platelets versus the population receiving saline.
Transfusion effects on coagulation	72 Hours	Changes in a biomarker for coagulation (prothrombin fragment 1-2) will be measured (pg/mL) at baseline (prior to transfusion) and up to 72 hours after transfusion and compared between the population receiving a unit of platelets versus the population receiving saline.
Transfusion effects on platelet number	72 Hours	Changes in platelet count (platelets/mm\^3 blood) at baseline (prior to transfusion) and up to 72 hours after transfusion and compared between the population receiving a unit of platelets versus the population receiving saline.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States