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Completed

NCT Number: NCT06312488

Point of Care Evaluation of Fibrinolysis in Sepsis

Impaired fibrinolysis in septic patients is associated with worse outcome. The present study investigates fibrinolysis shutdown in septic patients, defined as prolonged ClotPro® TPA lysis time at 30 minutes. The TPA lysis time reference range is established in a cohort of healthy volunteers.

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Key information

Conditions

Fibrinolytic Defect Critical Illness Disease Attributes Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years
  • sepsis or septic shock
  • vasopressors required to maintain a MAP ≥ 65 mmHg despite adequate fluid resuscitation

Exclusion criteria

  • coagulation disorders
  • ECMO therapy
  • use of oral anticoagulant drugs

Treatment and study plan

Clot Pro

Diagnostic Test

This study enrolls patients admitted to the Adult ICU of Milan Policlinico Hospital with a diagnosis of sepsis or septic shock. A ClotPro® TPA test is performed at admission and on day 1, 2, 3, and 7. Specific markers of coagulation (PAI-1, Plasminogen, Protein C and S) and inflammation (Il-1beta, IL-6, IL-8, TNF-alpha, ADM) are tested at enrollment. Routine laboratory tests are performed daily. Hemorrhagic and thrombotic events are searched. The study ends at 28 days or upon ICU discharge.

Primary outcomes

  1. Prevalence of impaired fibrinolysis

    Time frame: Lysis time at 30 minutes at enrollment and on day 1, 2, 3, and 7

    Lysis time at 30 minutes longer than 97.5th percentile of the calculated reference range of the ClotPro® TPA test

Secondary outcomes

  1. Correlation between impaired fibrinolysis and changes in coagulation standard tests

    Time frame: Measures are performed at enrollment and on day 1, 2, 3, and 7

    Number of patients with impaired fibrinolysis who have other abnormalities in standard coagulation tests (increased PT and PTT, decreased platelet count, increased D-dimer and decreased fibrinogen)

  2. Correlation between impaired fibrinolysis and inflammation markers

    Time frame: Measures are performed at enrollment and on day 1, 2, 3, and 7

    Number of patients with impaired fibrinolysis who have increased serum C-reactive protein and/or procalcitonin

  3. Correlation between impaired fibrinolysis and multiorgan failure

    Time frame: Measures are performed at enrollment and on day 1, 2, 3, and 7

    Number of patients with impaired fibrinolysos who develop multiorgan failure, defined as SOFA score > 5

  4. Correlation between impaired fibrinolysis and ICU lenght of stay

    Time frame: Through study completion, an average of 1 year

    Differential in number of days in ICU in patients with and without impaired fibrinolysis

  5. Correlation between impaired fibrinolysis and ICU mortality

    Time frame: From date of enrollment until date of ICU discharge or date of death from any cause, whichever comes first, assessed up to 1 year

    Mortality rate in patients with and without impaired fibrinolysis

Other outcomes

  1. Trend of fibrinolysis in the first ICU week with repeated ClotPro® tests

    Time frame: ClotPro® tests are performed at enrollment and on day 1, 2, 3, and 7

    Variation of TPA lysis time

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Acronym: POCEFIS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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