Trial · NCT07897006
Safflower (Carthamus Tinctorius L.) Granules for Sepsis-associated Coagulopathy
NCT07897006, Not applicable, Not yet recruiting, Shanghai Jiao Tong University School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safflower (Carthamus Tinctorius L.) Granules for Sepsis-associated Coagulopathy. Trials, record NCT07897006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07897006
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safflower (Carthamus Tinctorius L.) Granules for Sepsis-associated Coagulopathy
- NCT number
- NCT07897006
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 210 participants, estimated
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Conditions
- Sepsis, Disseminated Intravascular Coagulation (DIC)
- Interventions
- High-dose safflower granules, Medium-dose safflower granules, Placebo granules (one-tenth of medium-dose safflower)
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in SOFA score from baseline to Day 14 | From baseline (before the first dose) through Day 14 | The Sequential Organ Failure Assessment (SOFA) score is a measure of organ dysfunction (range 0-24, higher scores indicate more severe dysfunction). The primary endpoint is the improvement value defined as the baseline SOFA score minus the Day 14 SOFA score, compared among the three groups. SOFA scores are assessed at baseline (before the first dose) and on Day 14. Component-level scores are reported separately as a pre-specified supportive outcome. |
| Secondary | Change in ISTH-DIC score from baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | The International Society on Thrombosis and Haemostasis (ISTH) overt disseminated intravascular coagulation score, calculated at each assessment time point from platelet count, prothrombin time, fibrinogen, and D-dimer (or fibrin degradation products); a total score of 5 or more indicates overt DIC. Analyzed as change from baseline. |
| Secondary | All-cause mortality at 28 days | 28 days after randomization | All-cause mortality is defined as death from any cause within 28 days after randomization, counted for all randomized participants regardless of causality assessment. Vital status at Day 28 is collected for all participants. |
| Secondary | ICU length of stay and total hospital length of stay | From randomization to hospital discharge or through study completion, an average of approximately 22 days | Duration of intensive care unit stay and total hospital stay, measured in days from randomization to ICU discharge and to hospital discharge or death, respectively, for all randomized participants. |
| Secondary | Change in SOFA Component Scores for Hepatic, Renal, Respiratory, and Cardiovascular Function from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | The total SOFA score (0-24) is the primary endpoint of this study; this outcome reports the pre-specified component-level analysis supporting it. The SOFA score grades six organ systems, each 0-4 points. This outcome reports the hepatic (serum total bilirubin), renal (serum creatinine or receipt of renal replacement therapy), respiratory (PaO2/FiO2 ratio), and cardiovascular (mean arterial pressure and vasopressor use) components, each scored 0-4 per the SOFA definitions in the Sepsis-3 criteria. Change is calculated as baseline minus the Day N score, consistent with the primary endpoint direction, so positive values indicate improvement; components are reported individually in points. |
| Secondary | Change in Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | Prothrombin time (PT, seconds) and activated partial thromboplastin time (APTT, seconds) measured from venous blood samples collected at each protocol-specified time point. |
| Secondary | Change in International Normalized Ratio (INR) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | The international normalized ratio (INR), calculated from the prothrombin time and the international sensitivity index (ISI) of the thromboplastin reagent used, reported as a dimensionless ratio; analyzed as change from baseline. |
| Secondary | Change in Fibrinogen (FG) from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | Plasma fibrinogen concentration measured in venous blood samples collected at each protocol-specified time point, reported in g/L; analyzed as change from baseline. Fibrinogen is both an acute-phase reactant and the substrate of fibrin formation. |
| Secondary | Change in D-dimer from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | Plasma D-dimer, a marker of endogenous fibrin formation and degradation, measured in venous blood samples collected at each protocol-specified time point, reported in mg/L; analyzed as change from baseline. Elevated D-dimer at screening is an eligibility criterion of this study. |
| Secondary | Change in Platelet Count from Baseline to Day 14 | From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14 | Platelet count measured in venous blood samples collected at each protocol-specified time point, reported as 10\^9/L; analyzed as change from baseline. Platelet count is also a component of the ISTH-DIC score. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07897006
GET https://conductscience.org/api/trials/v1/NCT07897006/registered?page=2