This trial is active, not recruiting.

Condition sepsis syndrome
Sponsor Charalambos .A. Gogos
Collaborator Hellenic Society for Chemotherapy : Hellenic Sepsis Study Group
Start date January 2015
End date December 2016
Trial size 140 participants
Trial identifier NCT02562261, 24958/19-12-13


Activation of blood platelets is a typical finding in patients with systemic inflammation and sepsis.They seem to mediate key pro-inflammatory mediator secretion, immune-cell activation while their adhesion to the endothelium enhances the pro-coagulatory activity of endothelial cells impairing microcirculation thus, may lead to multiple organ dysfunction. However, the exact effects of bacterial products on platelet function have not been found to be consistent and may vary according to the species, the timing of the study, and the pathogenesis of sepsis. Data vary, including both increased and decreased platelet reactivity and aggregation among patients with sepsis compared to healthy controls. Defining platelet's behaviour during sepsis is particularly important in view of recent findings revealing potential association between antiplatelet therapy and reduction in short term mortality, incidence of acute lung injury and intensive care unit admission in critically ill patients.This study aims to measure P2Y12 mediated platelet reactivity, -using the point-of-care P2Y12 VerifyNow assay, in platelet reactivity units (PRU)- along different stages of sepsis, including bacteremia/uncomplicated infection, sepsis, severe sepsis and septic shock. Subgroup follow up of patients going along different stages will also be performed. At the end of this study analysis of clinical and laboratory findings in correlation with platelet reactivity will be performed to assess platelet aggregation during sepsis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Showing signs of infection as defined by International Sepsis Definitions Conference 2003
Sepsis is defined as systemic inflammatory response syndrome (i.e. presence of two or more of the following Temperature of <36 °C (96.8 °F) or >38 °C (100.4 °F) Heart rate >90bpm Respiratory rate >20/min or PaCO2<32 mmHg (4.3 kPa) WBC <4x109/L (<4000/mm³), >12x109/L (>12,000/mm³), or 10% bands in response to an infectious process..
Severe sepsis is defined as sepsis with sepsis-induced organ dysfunction or tissue hypoperfusion [manifesting as hypotension, elevated lactate (serum lactate 2 times the upper limit of normal), or decreased urine output (urine output < 0.5 ml/kg/hr)] Septic shock is defined as severe sepsis plus persistently low blood pressure (< 5th percentile for age or systolic blood pressure < 2 standard deviations below normal for age) following the administration of intravenous fluids.

Primary Outcomes

P2Y12 mediated Platelet Reactivity on presentation
time frame: 0 hours post presentation
Comparison of P2Y12 mediated Platelet Reactivity between study groups
time frame: at 1 year

Secondary Outcomes

Serum levels of pro-inflammatory mediators in various study groups
time frame: 1 month to 1 year
Correlation between serum levels of pro-inflammatory mediators and measured PRU between various study groups
time frame: 1 month to 1 year
Repeated measurement of PRU in the same subject when transiting from one group to another
time frame: 1 hour to 1 month

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - Patients presenting 0-8 hours post admission with signs of one of the following i) uncomplicated infection/bacteremia ii) sepsis iii) severe sepsis iv) septic shock - 30 healthy subjects - Signed informed consent Exclusion Criteria: - Pregnancy - Breastfeeding - Inability to give informed consent - PLTs<70.000/ul or PLTs>741.000 ul - Ht<25% or Ht>52% - History of P2Y12 or GPIIb/IIIainhibitors the last 15 days prior assortment - Patients with inherited (vonWillebrand factor deficiency, Glanzmann thrombasthenia, Bernard-Sulier syndrome) or established acquired platelet disorders (HIT) - Patients undergoing hemodialysis - History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months. - Previous history of immunologic disease (neoplasm, autoimmune disorders, HIV) - Subjects receiving daily treatment with immune-modulating regimens.

Additional Information

Official title Platelet Reactivity During Different Stages of Sepsis
Principal investigator Karolina Akinosoglou, MD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Hospital of Patras.