Fibrinolytic DefectPOCEFISNCT06312488
Point of Care Evaluation of Fibrinolysis in Sepsis
A study testing Clot Pro in people with Fibrinolytic Defect and Sepsis, run by Policlinico Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibrinolytic Defect, Sepsis, Critical Illness
- What is being tested?
- Clot Pro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jan 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age > 18 years
- sepsis or septic shock
- vasopressors required to maintain a MAP ≥ 65 mmHg despite adequate fluid resuscitation
Who cannot join
- coagulation disorders
- ECMO therapy
- use of oral anticoagulant drugs
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, 20100
About this study
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
- Being tested
- Clot Pro
- Medical subject headings
- Fibrinolytic Defect, Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clot ProDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Septic patients | Other | Not described Receives: Diagnostic Test: Clot Pro |
| Healthy volunteers | Other | Not described Receives: Diagnostic Test: Clot Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of impaired fibrinolysis
Lysis time at 30 minutes longer than 97.5th percentile of the calculated reference range of the ClotPro® TPA test
Measured: Lysis time at 30 minutes at enrollment and on day 1, 2, 3, and 7
Secondary outcomes (5)
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)
Measured: Measures are performed at enrollment and on day 1, 2, 3, and 7
Correlation between impaired fibrinolysis and inflammation markers
Number of patients with impaired fibrinolysis who have increased serum C-reactive protein and/or procalcitonin
Measured: Measures are performed at enrollment and on day 1, 2, 3, and 7
Correlation between impaired fibrinolysis and multiorgan failure
Number of patients with impaired fibrinolysos who develop multiorgan failure, defined as SOFA score > 5
Measured: Measures are performed at enrollment and on day 1, 2, 3, and 7
Correlation between impaired fibrinolysis and ICU lenght of stay
Differential in number of days in ICU in patients with and without impaired fibrinolysis
Measured: Through study completion, an average of 1 year
Correlation between impaired fibrinolysis and ICU mortality
Mortality rate in patients with and without impaired fibrinolysis
Measured: From date of enrollment until date of ICU discharge or date of death from any cause, whichever comes first, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start22 Jan 2024
- Primary completion31 Mar 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrinolytic DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Panigada, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312488
- Sponsor's protocol ID
- 4097
- Acronym
- POCEFIS
- Status last verified
- Mar 2024
- First submitted
- 21 Dec 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Evaluation of Fibrinolysis in Sepsis
- ClinicalTrials.gov ID
- NCT06312488
- Acronym / sponsor ID
- POCEFIS / 4097
- Conditions
- Fibrinolytic Defect, Sepsis, Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic patients | Other | Diagnostic Test: Clot Pro |
| Healthy volunteers | Other | Diagnostic Test: Clot Pro |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- sepsis or septic shock
- vasopressors required to maintain a MAP ≥ 65 mmHg despite adequate fluid resuscitation
Key exclusion criteria (3 listed)
- coagulation disorders
- ECMO therapy
- use of oral anticoagulant drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clot ProThis 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. | Diagnostic test | Healthy volunteers, Septic patients |
Primary outcome
Prevalence of impaired fibrinolysis
Time frame: Lysis time at 30 minutes at enrollment and on day 1, 2, 3, and 7
Lysis time at 30 minutes longer than 97.5th percentile of the calculated reference range of the ClotPro® TPA test
5 secondary outcomes
Correlation between impaired fibrinolysis and changes in coagulation standard tests
Time frame: Measures are performed at enrollment and on day 1, 2, 3, and 7
Correlation between impaired fibrinolysis and inflammation markers
Time frame: Measures are performed at enrollment and on day 1, 2, 3, and 7
Correlation between impaired fibrinolysis and multiorgan failure
Time frame: Measures are performed at enrollment and on day 1, 2, 3, and 7
Correlation between impaired fibrinolysis and ICU lenght of stay
Time frame: Through study completion, an average of 1 year
Correlation between impaired fibrinolysis and ICU mortality
Time frame: From date of enrollment until date of ICU discharge or date of death from any cause, whichever comes first, assessed up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clot Pro in people with Fibrinolytic Defect and Sepsis, run by Policlinico Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of impaired fibrinolysis (time frame: Lysis time at 30 minutes at enrollment and on day 1, 2, 3, and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.