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Platelet Reactivity in Septic Shock

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03716310
Enrollment
30
Registered
2018-10-23
Start date
2017-04-01
Completion date
2018-08-30
Last updated
2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTplatelet 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.

Sponsors

Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurence of sepsis-induced thrombocytopenia5 days after study inclusionOccurence of platelet count \<150 \*103/μL

Secondary

MeasureTime frame
life-threatening bleedingAfter 28 days from study inclusion
90-day mortalityafter 90 days from study enrollment
number of Red blood cells (RBC) packs transfused during ICU stayAfter 28 days from study inclusion

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026