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Platelet Reactivity in Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03716310
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Alberto Fogagnolo, 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.

Condition or disease Intervention/treatment
Septic Shock Thrombocytopenia Sepsis Platelet Aggregation Disseminated Intravascular Coagulation Diagnostic Test: platelet responsiveness evaluation

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impaired Platelet Reactivity as an Early Biomarker for Sepsis-related Thrombocytopenia
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Group/Cohort Intervention/treatment
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
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.

Primary Outcome Measures :
  1. Occurence of sepsis-induced thrombocytopenia [ Time Frame: 5 days after study inclusion ]
    Occurence of platelet count <150 *103/μL

Secondary Outcome Measures :
  1. life-threatening bleeding [ Time Frame: After 28 days from study inclusion ]
  2. 90-day mortality [ Time Frame: after 90 days from study enrollment ]
  3. number of Red blood cells (RBC) packs transfused during ICU stay [ Time Frame: After 28 days from study inclusion ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in intensive care unit

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03716310

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Università di Ferrara
Ferrara, Italy, 44121
Sponsors and Collaborators
Università degli Studi di Ferrara

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Responsible Party: Alberto Fogagnolo, MD, Università degli Studi di Ferrara Identifier: NCT03716310    
Other Study ID Numbers: Sepsisplt
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Disseminated Intravascular Coagulation
Systemic Inflammatory Response Syndrome
Pathologic Processes
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders