SepsisINFUSENCT03090919
The INFUSE Trial - Intervening With Platelet Transfusions in Sepsis
A study testing Platelet transfusion and Saline in people with Sepsis and Thrombocytopenia, run by Susan Smyth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Thrombocytopenia
- What is being tested?
- Platelet transfusion and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2017to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sepsis, Thrombocytopenia
- Being tested
- Platelet transfusion, Saline
- Medical subject headings
- Sepsis, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet transfusionBiological
SalineOther
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Subjects randomized to the Saline arm will receive 250cc of physiological saline. Receives: Other: Saline |
| Platelet transfusion | Experimental | Subjects randomized to platelet transfusion will receive a unit of platelets (~250cc in volume). Receives: Biological: Platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers for vascular integrity
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.
Measured: 24 Hours
Biomarkers for inflammation
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.
Measured: 24 Hours
Secondary outcomes (4)
Transfusion effects on cytokines
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.
Measured: 72 Hours
Incidence of Serious Adverse Events
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.
Measured: 30 days
Transfusion effects on coagulation
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.
Measured: 72 Hours
Transfusion effects on platelet number
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.
Measured: 72 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start3 Jan 2017
- Primary completion31 May 2021
- Study completion31 May 2021
Why it stopped: No subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to recieve either a platelet transfusion or a saline transfusion.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan Smyth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susan Smyth, University of Kentucky
- Investigators
- Susan S Smyth, MD PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090919
- Sponsor's protocol ID
- 16-0784-F6A
- Acronym
- INFUSE
- Status last verified
- Jul 2021
- First submitted
- 24 Jan 2017
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Z, Yang F, Dunn S, Gross AK, Smyth SS. Platelets as immune mediators: their role in host defense responses and sepsis. Thromb Res. 2011 Mar;127(3):184-8. doi: 10.1016/j.thromres.2010.10.010. Epub 2010 Nov 13.
PubMed 21075430Hui P, Cook DJ, Lim W, Fraser GA, Arnold DM. The frequency and clinical significance of thrombocytopenia complicating critical illness: a systematic review. Chest. 2011 Feb;139(2):271-278. doi: 10.1378/chest.10-2243. Epub 2010 Nov 11.
PubMed 21071526Sharma B, Sharma M, Majumder M, Steier W, Sangal A, Kalawar M. Thrombocytopenia in septic shock patients--a prospective observational study of incidence, risk factors and correlation with clinical outcome. Anaesth Intensive Care. 2007 Dec;35(6):874-80. doi: 10.1177/0310057X0703500604.
PubMed 18084977Claushuis TA, van Vught LA, Scicluna BP, Wiewel MA, Klein Klouwenberg PM, Hoogendijk AJ, Ong DS, Cremer OL, Horn J, Franitza M, Toliat MR, Nurnberg P, Zwinderman AH, Bonten MJ, Schultz MJ, van der Poll T; Molecular Diagnosis and Risk Stratification of Sepsis Consortium. Thrombocytopenia is associated with a dysregulated host response in critically ill sepsis patients. Blood. 2016 Jun 16;127(24):3062-72. doi: 10.1182/blood-2015-11-680744. Epub 2016 Mar 8.
PubMed 26956172Xiang B, Zhang G, Guo L, Li XA, Morris AJ, Daugherty A, Whiteheart SW, Smyth SS, Li Z. Platelets protect from septic shock by inhibiting macrophage-dependent inflammation via the cyclooxygenase 1 signalling pathway. Nat Commun. 2013;4:2657. doi: 10.1038/ncomms3657.
PubMed 24150174
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INFUSE Trial - Intervening With Platelet Transfusions in Sepsis
- ClinicalTrials.gov ID
- NCT03090919
- Acronym / sponsor ID
- INFUSE / 16-0784-F6A
- Conditions
- Sepsis, Thrombocytopenia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Susan SmythUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized to recieve either a platelet transfusion or a saline transfusion.
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Other: SalineSubjects randomized to the Saline arm will receive 250cc of physiological saline. |
| Platelet transfusion | Experimental | Biological: Platelet transfusionSubjects randomized to platelet transfusion will receive a unit of platelets (~250cc in volume). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet transfusion | Biological | Platelet transfusion |
| Saline | Other | Saline |
Primary outcome
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.
4 secondary outcomes
Transfusion effects on cytokines
Time frame: 72 Hours
Incidence of Serious Adverse Events
Time frame: 30 days
Transfusion effects on coagulation
Time frame: 72 Hours
Transfusion effects on platelet number
Time frame: 72 Hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Background: PubMed 21075430Li Z, Yang F, Dunn S, Gross AK, Smyth SS. Platelets as immune mediators: their role in host defense responses and sepsis. Thromb Res. 2011 Mar;127(3):184-8. doi: 10.1016/j.thromres.2010.10.010. Epub 2010 Nov 13.
- Background: PubMed 21071526Hui P, Cook DJ, Lim W, Fraser GA, Arnold DM. The frequency and clinical significance of thrombocytopenia complicating critical illness: a systematic review. Chest. 2011 Feb;139(2):271-278. doi: 10.1378/chest.10-2243. Epub 2010 Nov 11.
- Background: PubMed 18084977Sharma B, Sharma M, Majumder M, Steier W, Sangal A, Kalawar M. Thrombocytopenia in septic shock patients--a prospective observational study of incidence, risk factors and correlation with clinical outcome. Anaesth Intensive Care. 2007 Dec;35(6):874-80. doi: 10.1177/0310057X0703500604.
- Background: PubMed 26956172Claushuis TA, van Vught LA, Scicluna BP, Wiewel MA, Klein Klouwenberg PM, Hoogendijk AJ, Ong DS, Cremer OL, Horn J, Franitza M, Toliat MR, Nurnberg P, Zwinderman AH, Bonten MJ, Schultz MJ, van der Poll T; Molecular Diagnosis and Risk Stratification of Sepsis Consortium. Thrombocytopenia is associated with a dysregulated host response in critically ill sepsis patients. Blood. 2016 Jun 16;127(24):3062-72. doi: 10.1182/blood-2015-11-680744. Epub 2016 Mar 8.
- Background: PubMed 24150174Xiang B, Zhang G, Guo L, Li XA, Morris AJ, Daugherty A, Whiteheart SW, Smyth SS, Li Z. Platelets protect from septic shock by inhibiting macrophage-dependent inflammation via the cyclooxygenase 1 signalling pathway. Nat Commun. 2013;4:2657. doi: 10.1038/ncomms3657.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan S Smyth, MD PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet transfusion and Saline in people with Sepsis and Thrombocytopenia, run by Susan Smyth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers for vascular integrity (time frame: 24 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03090919, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.