Point of Care Evaluation of Fibrinolysis in Sepsis (POCEFIS)

Policlinico Hospital

Status: Enrolling

Conditions: Fibrinolytic Defect; Critical Illness; Sepsis

Treatments: Diagnostic Test: Clot Pro

Study type: Interventional

Funder types: Other

Identifiers

NCT06312488

4097

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Septic patients

Other group

Treatment:

Diagnostic Test: Clot Pro

Healthy volunteers

Other group

Treatment:

Diagnostic Test: Clot Pro