Platelet Reactivity in Septic Shock

Study Overview
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Brief Summary
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Coagulation disorders and thrombocytopenia are common in patients with septic shock. Despite the clinical relevance of sepsis-induced thrombocytopenia, few studies have focused on the prediction of thrombocytopenia in this setting. The aim of this study was to evaluate whether platelets aggregometry and markers of platelets activation, such as mean platelet volume or platelet volume distribution width, could predict sepsis-induced thrombocytopenia in patients with septic shock and normal platelet count on the day of diagnosis.

Official Title
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Impaired Platelet Reactivity as an Early Biomarker for Sepsis-related Thrombocytopenia

Conditions
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Septic Shock, Thrombocytopenia, Sepsis, Platelet Aggregation, Disseminated Intravascular Coagulation

Intervention / Treatment
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* Diagnostic Test: platelet responsiveness evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of septic shock platelet count >150*103/mcL. Exclusion Criteria: age <18 years history of any hematologic disorder chronic liver failure previous chemotherapy transfusion of platelet during the previous 4 weeks renal replacement therapy before ICU admission history of antiplatelet therapy during the 8 days before inclusion history of heparin-induced thrombocytopenia (HIT) or other acquired or induced thrombocytopenia occurrence of HIT (defined as HIT score over 3) active bleeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| septic shock patients<br>Inclusion criteria of the study were diagnosis of septic shock and a platelet count >150*103/mcL. | Diagnostic Test: platelet responsiveness evaluation<br>* Blood samples were anticoagulated with 0.129 mmol/L of sodium citrate and then centrifugated for 10 min at 200 rpm; platelets aggregation was assessed with an AggRAM Advanced Modular System light transmittance aggregometer (Helena Laboratories, Beaumont, Texas, USA). Low-molecular-weight heparin (LMWH) was given at least 8 hours before any blood aggregation sample. Agonist used to initiate aggregation test were: -Adenosine diphosphate (ADP) to assess P2Y12-dependent platelet aggregation; (20 ng) - Arachidonic acid (AA) to assess cyclooxygenase-dependent platelet Adenosine diphosphate aggregation (1 mcg) - thrombin receptor-activating peptide-6 (TRAP-6) to assess protease-activated receptor 1-dependent platelet aggregation. Max aggregation reached (Aggmax), the slope of the curve (slope) and the latency time (lat) were analyzed for each agonist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of sepsis-induced thrombocytopenia | Occurence of platelet count <150 *103/μL | 5 days after study inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| life-threatening bleeding |  | After 28 days from study inclusion | 
| 90-day mortality |  | after 90 days from study enrollment | 
| number of Red blood cells (RBC) packs transfused during ICU stay |  | After 28 days from study inclusion |