Point of Care Evaluation of Fibrinolysis in Sepsis

Sepsis Clinical Trial

— POCEFIS  

Official title:

Point of Care Evaluation of Fibrinolysis in Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312488
• Other study ID #: 4097
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Sepsis
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Trend of fibrinolysis in the first ICU week with repeated ClotPro® tests	Variation of TPA lysis time	ClotPro® tests are performed at enrollment and on day 1, 2, 3, and 7
Primary	Prevalence of impaired fibrinolysis	Lysis time at 30 minutes longer than 97.5th percentile of the calculated reference range of the ClotPro® TPA test	Lysis time at 30 minutes at enrollment and on day 1, 2, 3, and 7
Secondary	Correlation between impaired fibrinolysis and changes in coagulation standard tests	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)	Measures are performed at enrollment and on day 1, 2, 3, and 7
Secondary	Correlation between impaired fibrinolysis and inflammation markers	Number of patients with impaired fibrinolysis who have increased serum C-reactive protein and/or procalcitonin	Measures are performed at enrollment and on day 1, 2, 3, and 7
Secondary	Correlation between impaired fibrinolysis and multiorgan failure	Number of patients with impaired fibrinolysos who develop multiorgan failure, defined as SOFA score > 5	Measures are performed at enrollment and on day 1, 2, 3, and 7
Secondary	Correlation between impaired fibrinolysis and ICU lenght of stay	Differential in number of days in ICU in patients with and without impaired fibrinolysis	Through study completion, an average of 1 year
Secondary	Correlation between impaired fibrinolysis and ICU mortality	Mortality rate in patients with and without impaired fibrinolysis	From date of enrollment until date of ICU discharge or date of death from any cause, whichever comes first, assessed up to 1 year