Evaluating blood clotting in patients with sepsis
Point of Care Evaluation of Fibrinolysis in Sepsis
This study is testing how blood clotting works in people with sepsis to see if it can help doctors understand the severity of the condition and improve treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Policlinico Hospital Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06312488 on ClinicalTrials.gov |
What this trial studies
This study investigates the shutdown of fibrinolysis in patients suffering from sepsis, which is linked to poorer outcomes. It focuses on measuring the TPA lysis time using the ClotPro® device in septic patients, comparing these results to a reference range established from healthy volunteers. The aim is to better understand the relationship between impaired fibrinolysis and sepsis severity, potentially guiding treatment decisions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are experiencing sepsis or septic shock and require vasopressors to maintain blood pressure.
Not a fit: Patients with coagulation disorders, those on ECMO therapy, or those using oral anticoagulants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of sepsis by identifying patients at risk for worse outcomes due to fibrinolytic defects.
How similar studies have performed: While this approach is focused on a specific aspect of sepsis management, similar studies have shown that understanding coagulation abnormalities can significantly impact treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan, MI
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Mi, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.