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Clinical Trials/NCT03716310
NCT03716310
Completed
Not Applicable

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

Università degli Studi di Ferrara1 site in 1 country30 target enrollmentApril 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Septic Shock
Sponsor
Università degli Studi di Ferrara
Enrollment
30
Locations
1
Primary Endpoint
Occurence of sepsis-induced thrombocytopenia
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
August 30, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Università degli Studi di Ferrara
Responsible Party
Principal Investigator
Principal Investigator

Alberto Fogagnolo

MD

Università degli Studi di Ferrara

Eligibility Criteria

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

Outcomes

Primary Outcomes

Occurence of sepsis-induced thrombocytopenia

Time Frame: 5 days after study inclusion

Occurence of platelet count \<150 \*103/μL

Secondary Outcomes

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

Study Sites (1)

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