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The INFUSE Trial - Intervening With Platelet Transfusions in Sepsis (INFUSE)

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ClinicalTrials.gov Identifier: NCT03090919
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Susan Smyth, University of Kentucky

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sepsis Thrombocytopenia Biological: Platelet transfusion Other: Saline Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to recieve either a platelet transfusion or a saline transfusion.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The INFUSE Trial - Intervening With Platelet Transfusions in Sepsis
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Biomarkers for vascular integrity [ Time Frame: 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.

  2. Biomarkers for inflammation [ Time Frame: 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 :
  1. Transfusion effects on cytokines [ Time Frame: 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.

  2. Incidence of Serious Adverse Events [ Time Frame: 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.

  3. Transfusion effects on coagulation [ Time Frame: 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.

  4. Transfusion effects on platelet number [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090919


Contacts
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Contact: Susan S Smyth, MD PhD 859-323-2274 susan.smyth@uky.edu
Contact: Travis R Sexton, PhD 859-323-3617 trsext2@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Susan Smyth, MD    859-323-2274    ssmyt2@email.uky.edu   
Contact: Travis R Sexton, PhD    859-323-3617    trsext2@uky.edu   
Principal Investigator: Susan Smyth, MD         
Sponsors and Collaborators
University of Kentucky
Investigators
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Principal Investigator: Susan S Smyth, MD PhD University of Kentucky
More Information
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Publications:

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Responsible Party: Susan Smyth, Principle Investigators, University of Kentucky
ClinicalTrials.gov Identifier: NCT03090919     History of Changes
Other Study ID Numbers: 16-0784-F6A
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Thrombocytopenia
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Blood Platelet Disorders
Hematologic Diseases