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A multicenter, prospective, double-blind, randomized controlled trial (XBJ-SIC) of Xuebijing Injection for the treatment of sepsis-induced coagulopathy

A multicenter, prospective, double-blind, randomized controlled trial (XBJ-SIC) of Xuebijing Injection for the treatment of sepsis-induced coagulopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111743
Enrollment
Unknown
Registered
2025-11-05
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis-induced coagulopathy

Interventions

Xuebijing Treatment Group:TheXuebijing Treatment group received 100ml of XBJ + 100ml of normal saline for 12 consecutive hours, followed by standard treatment with SIC for 5 days.
Control treatment group:The control group received 100ml of placebo + 100ml of normal saline for 12 hours, and was treated with standard SIC for 5 consecutive days.

Sponsors

Shanghai East Hospital (East Hospital Affiliated to Tongji University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-80 years old, meeting Sepsis-3 diagnostic criteria (infection +?SOFA or ?qSOFA>=2 points). 2.SIC score >=4 points (based on ISTH 2017 standard) (for details, see Appendix 2). 3.The time from Sepsis to the diagnosis of SIC is less than or equal to 24 hours. 4. No anticoagulant and antiplate therapy was received before diagnosis.

Exclusion criteria

Exclusion criteria: 1.There are other coagulation disorders (TTP, HIT, hemolytic uremic syndrome). 2. There are serious primary diseases, including tumors discovered within half a year, hematological diseases, and severe liver and kidney diseases (such as liver cirrhosis and terminal chronic renal failure). 3. Pregnant or lactating women. 4.Within 4.6 months, immunosuppressants have been used or organ transplants have been received. 5. Has participated in other clinical trials. 6. Patients who the researchers considered unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
SIC remission rate;

Secondary

MeasureTime frame
Coagulation index;Inflammatory indicators;APACHE?score;SOFA score;28-day all-cause mortality rate;Mechanical ventilation time;Blood purification time;Four items of new thrombosis;Cellular immune function;

Countries

China

Contacts

Public ContactFeng Zhu

Shanghai East Hospital (East Hospital Affiliated to Tongji University)

alexzhujunchi@hotmail.com+86 21 3883 8434

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026