Platelet Reactivity in Septic Shock

Completed

• Conditions: Thrombocytopenia; Sepsis; Septic Shock; Platelet Aggregation; Disseminated Intravascular Coagulation
• Interventions: Diagnostic Test: platelet responsiveness evaluation

• Registration Number: NCT03716310
• Lead Sponsor: Università degli Studi di Ferrara

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-05-30
• Study Completion: 2018-08-30
• Status Verified: 2018-10
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-19
• Study First Posted: 2018-10-23
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
septic shock patients	platelet responsiveness evaluation	Inclusion criteria of the study were diagnosis of septic shock and a platelet count \>150\*103/mcL.

Primary Outcome Measures

Name	Time	Method
Occurence of sepsis-induced thrombocytopenia	5 days after study inclusion	Occurence of platelet count \<150 \*103/μL

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Università di Ferrara; 🇮🇹 Ferrara, Italy