Platelet Reactivity in Septic Shock

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716310
• Other study ID #: Sepsisplt
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: October 2018
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• platelet responsiveness evaluation
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.

Locations

Country	Name	City	State
Italy	Università di Ferrara	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Campo G, Valgimigli M, Gemmati D, Percoco G, Tognazzo S, Cicchitelli G, Catozzi L, Malagutti P, Anselmi M, Vassanelli C, Scapoli G, Ferrari R. Value of platelet reactivity in predicting response to treatment and clinical outcome in patients undergoing primary coronary intervention: insights into the STRATEGY Study. J Am Coll Cardiol. 2006 Dec 5;48(11):2178-85. Epub 2006 Nov 13. — View Citation

Dewitte A, Lepreux S, Villeneuve J, Rigothier C, Combe C, Ouattara A, Ripoche J. Blood platelets and sepsis pathophysiology: A new therapeutic prospect in critical ill patients? Ann Intensive Care. 2017 Dec 1;7(1):115. doi: 10.1186/s13613-017-0337-7. Review. Erratum in: Ann Intensive Care. 2018 Feb 28;8(1):32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of sepsis-induced thrombocytopenia	Occurence of platelet count <150 *103/µL	5 days after study inclusion
Secondary	life-threatening bleeding		After 28 days from study inclusion
Secondary	90-day mortality		after 90 days from study enrollment
Secondary	number of Red blood cells (RBC) packs transfused during ICU stay		After 28 days from study inclusion