Viscoelastic Coagulation Monitoring for Early Identification of Sepsis: The VISION II Study
NCT07927621, Not yet recruiting, Hellenic Institute for the Study of Sepsis
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Viscoelastic Coagulation Monitoring for Early Identification of Sepsis: The VISION II Study | ClinicalTrials.gov |
| NCT number | NCT07927621 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 400 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Hellenic Institute for the Study of Sepsis | ClinicalTrials.gov |
| Conditions | Sepsis, Infection, Sepsis-Induced Coagulopathy | ClinicalTrials.gov |
| Interventions | Viscoelastic Coagulation Monitor (VCM) testing | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Differences in VCM parameters between patients who develop sepsis and those who do not | From enrollment through 72 hours | The eight VCM-derived parameters will be compared between patients who develop sepsis and those who do not. Sepsis will be defined according to the Sepsis-3 criteria as suspected or confirmed infection accompanied by an increase of ≥2 points in the Sequential Organ Failure Assessment (SOFA)-2 score or more from baseline. | ClinicalTrials.gov |
| Secondary | Clotting Time in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy | From enrollment to 72 hours | Clotting time (CT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy. | ClinicalTrials.gov |
| Secondary | Clot Formation Time in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy | At enrollment and at 24, 48, and 72 hours | Clot formation time (CFT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared using the Mann-Whitney U test between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy. | ClinicalTrials.gov |
| Secondary | Alpha Angle in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy | At enrollment and at 24, 48, and 72 hours. | Alpha angle, measured in degrees using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy. | ClinicalTrials.gov |
| Secondary | Amplitude at 10 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy | At enrollment and at 24, 48, and 72 hours. | Amplitude at 10 minutes (A10), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy. | ClinicalTrials.gov |
| Secondary | Maximum Clot Firmness in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy | At enrollment and at 24, 48, and 72 hours. | Maximum clot firmness (MCF), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy. | ClinicalTrials.gov |
| Secondary | Lysis Index at 30 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy | At enrollment and at 24, 48, and 72 hours. | Lysis index at 30 minutes (LI30), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy. | ClinicalTrials.gov |
| Secondary | Lysis Index at 45 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy | At enrollment and at 24, 48, and 72 hours. | Lysis index at 45 minutes (LI45), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy. | ClinicalTrials.gov |
| Secondary | Amplitude at 20 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy | At enrollment and at 24, 48, and 72 hours. | Amplitude at 20 minutes (A20), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy. | ClinicalTrials.gov |
| Secondary | Use of chronic anticoagulant therapy or antiplatelet therapy | At enrollment | Number and proportion of enrolled patients receiving chronic anticoagulant therapy and those not receiving anticoagulant therapy. | ClinicalTrials.gov |
| Secondary | Clotting Time in Participants With and Without a Major Thromboembolic Event | At enrollment and at 24, 48, and 72 hours. | Clotting time (CT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants who develop a major thromboembolic event and participants who do not develop such an event within the first 72 hours after enrollment. | ClinicalTrials.gov |
| Secondary | Clot Formation Time in Participants With and Without a Major Thromboembolic Event | At enrollment and at 24, 48, and 72 hours. | Clot formation time (CFT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants who develop a major thromboembolic event and participants who do not develop such an event within the first 72 hours after enrollment. | ClinicalTrials.gov |
| Secondary | Alpha Angle in Participants With and Without a Major Thromboembolic Event | At enrollment and at 24, 48, and 72 hours. | Alpha angle, measured in degrees using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not. | ClinicalTrials.gov |
| Secondary | Amplitude at 10 Minutes in Participants With and Without a Major Thromboembolic Event | At enrollment and at 24, 48, and 72 hours. | Amplitude at 10 minutes (A10), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not. | ClinicalTrials.gov |
| Secondary | Amplitude at 20 Minutes in Participants With and Without a Major Thromboembolic Event | At enrollment and at 24, 48, and 72 hours. | Amplitude at 20 minutes (A20), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not. | ClinicalTrials.gov |
| Secondary | Lysis Index at 30 Minutes in Participants With and Without a Major Thromboembolic Event | At enrollment and at 24, 48, and 72 hours. | Lysis index at 30 minutes (LI30), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not. | ClinicalTrials.gov |
| Secondary | Lysis Index at 45 Minutes in Participants With and Without a Major Thromboembolic Event | At enrollment and at 24, 48, and 72 hours. | Lysis index at 45 minutes (LI45), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not. | ClinicalTrials.gov |
| Secondary | Maximum Clot Firmness in Participants With and Without a Major Thromboembolic Event | At enrollment and at 24, 48, and 72 hours. | Maximum clot firmness (MCF), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not. | ClinicalTrials.gov |
| Secondary | Occurrence of sepsis among patients receiving chronic anticoagulant therapy | From enrollment to 72 hours | Number and proportion of patients receiving chronic anticoagulant therapy who develop sepsis, as defined by the Sepsis-3 criteria, during the study follow-up period. | ClinicalTrials.gov |
| Secondary | Cumulative number of out-of-range VCM parameters | At enrollment and at 24, 48, and 72 hours | The cumulative number of VCM parameters outside their predefined reference ranges will be determined at enrollment and at 24, 48, and 72 hours and compared between patients who develop sepsis and those who do not. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)