Platelet Reactivity in Septic Shock

NCT03716310 | Completed

• 1 other identifier: Sepsisplt
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Occurence of sepsis-induced thrombocytopenia

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

  5 days after study inclusion

Secondary Outcomes (3)

• life-threatening bleeding

  After 28 days from study inclusion

• 90-day mortality

  after 90 days from study enrollment

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

  After 28 days from study inclusion

Study Arms (1)

septic shock patients

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

Diagnostic Test: platelet responsiveness evaluation

Interventions

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.

septic shock patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in intensive care unit

You may qualify if:

• diagnosis of septic shock
• platelet count \>150\*103/mcL.

You may not qualify if:

• 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 heparin-induced thrombocytopenia (HIT) or other acquired or induced thrombocytopenia
• occurrence of HIT (defined as HIT score over 3)
• active bleeding

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Università di Ferrara

Ferrara, 44121, Italy

Location

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

  PMID: 17161242 BACKGROUND

• 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.

  PMID: 29192366 BACKGROUND

MeSH Terms

Conditions

Shock, Septic; Thrombocytopenia; Sepsis; Disseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Blood Coagulation Disorders; Hemorrhagic Disorders; Thrombophilia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 23, 2018
• Study Start: April 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: August 30, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

IT (1)