ClinicalTrials.gg
Not yet recruitingNCT06920420Updated Apr 9, 2025

Novel Biomarkers Related Xuebijing Injection Improves Sepsis

An observational study in Sepsis, sponsored by Southeast University, China. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Southeast University, China · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 21 studies in Sepsis by Southeast University, China — 7 open to participants now, 8 under way, 1 of them phase 3. Sepsis · Southeast University, China.

Started
2025
with 2 others
Observational
9 of 21
5 open now
Registered
16th of 21
by date

Among the 21 studies in Sepsis by Southeast University, China, this one is one of 3 that started in 2025, is one of 9 observational ones, and was the 16th registered.

Sepsis

2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.

Browse Sepsis studies →

Open to participants now

7 of the 21 studies in Sepsis by Southeast University, China are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study summary

Sepsis is a life-threatening clinical syndrome of organ dysfunction caused by dysregulation of the body's response to infection, and is a common cause of ICU admission for critically ill patients, posing a serious threat to human health. The study demonstrated that hemopexin injection significantly reduced the 28-day all-cause mortality rate of sepsis patients, and this study clarified the specific target and molecular mechanism of hemopexin injection in the treatment of sepsis, which may be of great scientific significance and clinical value for the precise treatment of sepsis and the research and development of new drugs.

03

Conditions studied

  • Sepsis

Browse trials for

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Sepsis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Meeting the Sepsis 3.0 diagnostic criteria;
  2. SOFA score ≥ 2 and \< 13;
  3. Signed .

Exclusion criteria

Exclusion Criteria:

  1. Age \<18 years or >75 years;
  2. Pregnant or lactating women;
  3. Presence of severe primary diseases including malignant tumors severe hematologic disorders and infection;
  4. Current use of or history of organ transplantation within the past 6 months;
  5. Comorbidities that significantly affect vascular endothelial structure and function such as acute myocardial infarction.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Xuebijing treatment group

    Based on the standard treatment group Xuebijing injection was added.

  • Standard treatment group

    Patients with sepsis are given standard treatment according to international guidelines for the management of sepsis and septic shock

  • Healthy Volunteer Group
06

What researchers measure

Primary outcomes

  1. Single-cell transcriptomic analysis of inflammatory and metabolic gene expression, measured using scRNA-seq, with data summarized as differential expression profiles.

    Single-cell transcriptomic analysis of inflammatory and metabolic gene expression, measured using scRNA-seq, with data summarized as differential expression profiles.

    Time frame: Day7

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Individual patient data, including genetic information, will not be shared due to privacy and ethical considerations. Genetic data is highly sensitive and could potentially identify individuals. To protect patient confidentiality and comply with regulations such as GDPR and HIPAA, access to such data is strictly limited and will only be shared under explicit informed consent and approved ethical guidelines.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2025; primary completion for Dec 2028, 45 months later.

Of 492 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 45 months is above that.

Counting every sponsor, half of 544 studies reached it within 27 months; a quarter within 12 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2025
First posted
Apr 9, 2025
StartEst.
Mar 30, 2025
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Apr 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06920420
Responsible party
Songqiao Liu (Prof, Southeast University, China) — Principal investigator
First posted
Apr 9, 2025
Start date
Mar 30, 2025 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 9, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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