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Point of Care Evaluation of Fibrinolysis in Sepsis

NCT06312488 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-08

No results posted yet for this study

Summary

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.

Conditions

  • Fibrinolytic Defect
  • Sepsis
  • Critical Illness

Interventions

DIAGNOSTIC_TEST

Clot Pro

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.

Sponsors & Collaborators

  • Policlinico Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2025-03-31
Completion
2025-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06312488 on ClinicalTrials.gov