Platelet Reactivity in Septic Shock

NCT ID: NCT03716310

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-08-30

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.

Conditions

Septic Shock; Thrombocytopenia; Sepsis; Platelet Aggregation; Disseminated Intravascular Coagulation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

septic shock patients

Inclusion criteria of the study were diagnosis of septic shock and a platelet count \>150\*103/mcL.

platelet responsiveness evaluation

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Alberto Fogagnolo

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Università di Ferrara

Ferrara, , Italy

Countries

Italy

References

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. doi: 10.1016/j.jacc.2005.12.085. Epub 2006 Nov 13.

Reference Type: BACKGROUND

PMID: 17161242 (View on PubMed)

Dewitte A, Lepreux S, Villeneuve J, Rigothier C, Combe C, Ouattara A, Ripoche J. Blood platelets and sepsis pathophysiology: A new therapeutic prospect in critically [corrected] ill patients? Ann Intensive Care. 2017 Dec 1;7(1):115. doi: 10.1186/s13613-017-0337-7.

Reference Type: BACKGROUND

PMID: 29192366 (View on PubMed)

Other Identifiers

Sepsisplt

Identifier Type: -

Identifier Source: org_study_id