Microcirculation and Coagulopathy in Sepsis ([MicroCOAG])

Relationship Between Microcirculatory Alterations and Coagulopathy in Sepsis: Prospective Observational Study.

Sepsis-induced coagulopathy (SIC) and microvascular dysfunction are hallmark features of sepsis, yet their longitudinal relationship remains poorly understood. The aim of this study is to investigate the interplay between sublingual microcirculation, endothelial damage, peripheral tissue oxygenation and coagulation parameters in patients with sepsis.

Study Overview

• Status: Completed
• Conditions: Sepsis; Coagulopathy

Detailed Description

Prospective observational study. Inclusion criteria: adult (>18 years of age) patients with sepsis or septic shock. Exclusion criteria:sepsis for more than 24 hours, pre-existing coagulopathy (severe liver disease, inherited bleeding disorders), concurrent use of therapeutic anticoagulation or thrombolytic agents, factors impeding the sublingual microvascular assessment (including maxillo-facial trauma or recent oral surgery) pregnancy and inability to obtain informed consent. For all patients we will record age, gender, admission diagnosis, source of sepsis, comorbidities, the Sequential Organ Failure Assessment (SOFA), the Acute Physiology and Chronic Evaluation II (APACHE II) and the Simplified Acute Physiology Score II (SAPS II). Clinical and laboratory data will be collected daily from day 0 to day 4, including mean arterial pressure (MAP), heart rate (HR), arterial lactate levels, use of sedatives, vasoactive agents with dosage and anticoagulant angents. At day 0, arterial blood samples will be withdrawn and immediately centrifuged; plasma samples will be stored at -70°C for measurement of Syndecan-1 and thrombomodulin levels.Standard coagulation laboratory tests will be analysed daily from day 0 to day 4, including platelet count, international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, antithrombin and D-dimer levels. The sepsis-induced coagulopathy (SIC) and the disseminated intravascular coagulation (DIC) scores will be calculated daily. Thromboelastography will be performed daily. The sublingual microcirculation will be assessed on day 0 and day 4 to evaluate parameters of vessel density and microvascular flow quality. Near Infrared Spectroscopy will be used on day 0 to evaluate tissue (thenar eminence) O2 saturation and its dynamic changes during a vascular occlusion test, providing indices of tissue O2 extraction capacity and microvascular reactivity.Data from previous studies suggest that at least 50% of patients with sepsis present with coagulopathy. The hypothesis underlying this study is that patients who develop sepsis-induced coagulopathy exhibit more severe microcirculatory alterations at the time of sepsis diagnosis. In a previous study involving septic patients, we observed a baseline Perfused Vessel Density (PVD) of 22.8±4.7 mm/mm2. Based on these data, and assuming a mean difference in PVD of at least 20% (±5%) between patients who develop SIC and those who do not (unpaired samples t-test), it was calculated that a total sample size of 30 patients would be sufficient to demonstrate a statistically significant difference with a power of 80% and an alpha error of 0.05.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy, 60126
    • Azienda Ospedaliero Universitaria delle Marche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

adult patients with sepsis or septic shock admitted to a 14-bed medical Intensive Care Unit

Description

Inclusion Criteria:

• adult (>18 years of age)
• sepsis or septic shock

Exclusion Criteria:

• sepsis for more than 24 hours
• pre-existing coagulopathy
• concurrent use of therapeutic anticoagulation or thrombolytic agents
• factors impeding the sublingual microvascular assessment
• pregnancy
• inability to obtain informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfused vessel density	difference between patients with sepsis induced coagulopathy and patients without coagulopathy	day 0 (on enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variations in microvascular parameters	evolution of microcirculatory alterations in patients with or without coagulopathy	day 0 to day 4 (96 hours)

Collaborators and Investigators

• Sponsor: Università Politecnica delle Marche

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: microcirculation; coagulopathy; sepsis; glycocalyx; tissue oxygenation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Sepsis; Hemostatic Disorders
• Other Study ID Numbers: Micro_COAG_2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No