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Completed

NCT Number: NCT03716310

Platelet Reactivity in Septic Shock

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.

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Key information

Conditions

Septic Shock Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Disseminated Intravascular Coagulation Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Platelet Aggregation Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Thrombocytopenia Thrombophilia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Università di Ferrara

Ferrara, 44121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

platelet responsiveness evaluation

Diagnostic Test

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.

Primary outcomes

  1. Occurence of sepsis-induced thrombocytopenia

    Time frame: 5 days after study inclusion

    Occurence of platelet count <150 *103/μL

Secondary outcomes

  1. life-threatening bleeding

    Time frame: After 28 days from study inclusion

  2. 90-day mortality

    Time frame: after 90 days from study enrollment

  3. number of Red blood cells (RBC) packs transfused during ICU stay

    Time frame: After 28 days from study inclusion

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 23, 2018
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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