NCT06312488

Point of Care Evaluation of Fibrinolysis in Sepsis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Policlinico Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-01-22
• Primary completion: 2025-03-31
• Completion: 2025-11-30
• First posted: 2024-03-15
• Last updated: 2026-04-08

Locations

1 site across 1 country: Italy