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
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Thrombocytopenia||Biological: Platelet transfusion Other: Saline||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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)|
|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|
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).
Biological: Platelet transfusion
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Susan S Smyth, MD PhDfirstname.lastname@example.org|
|Contact: Travis R Sexton, PhDemail@example.com|
|United States, Kentucky|
|University of Kentucky||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Contact: Susan Smyth, MD 859-323-2274 firstname.lastname@example.org|
|Contact: Travis R Sexton, PhD 859-323-3617 email@example.com|
|Principal Investigator: Susan Smyth, MD|
|Principal Investigator:||Susan S Smyth, MD PhD||University of Kentucky|