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Multicentre clinical Trial of Safflower Yellow on Prevention of Deep Vein Thrombosis in Sepsis Patients

Multicentre clinical Trial of Safflower Yellow on Prevention of Deep Vein Thrombosis in Sepsis Patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051038
Enrollment
Unknown
Registered
2021-09-10
Start date
2021-09-15
Completion date
Unknown
Last updated
2022-05-16

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

Conditions

Sepsis

Interventions

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. Actual weight >= 45kg; 3. ICU hospitalization time is expected to be >= 72 hours; 4. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Neurosurgery in the last three months; 2. Ischemic stroke occurred within the last 3 months; 3. Intracranial hemorrhage occurred within the last 3 months; 4. Systolic blood pressure >= 180mm Hg, diastolic blood pressure >= 110mm Hg, or vasoactive drug infusion is required for more than 12 hours; 5. Heavy bleeding in the past week, treat; 6. Abnormal coagulation at screening: INR>=2 times the upper limit of normal, or APTT>=2 times the normal value; 7. Thrombocytopenia at screening: platelet count <=75x10^9/L8; 8. Other heparin contraindications (such as heparin-induced thrombocytopenia, pregnancy, lactation); 9. Ultrasonography of lower extremities cannot be performed (such as bilateral amputations above the knees or severe distal lower extremity burns); 10. Limited life support, life expectancy <= 14 days, or palliative care; 11. Contamination (for example, 3 times of low molecular weight heparin was used after being admitted to the ICU); 12. Contraindications to blood products.

Design outcomes

Primary

MeasureTime frame
Bedside ultrasound screening;Bleeding and coagulation time;D dimer, procalcitonin, thromboregulatory protein, thrombin/antithrombin complex, tissue-type plasminogen activator - activator inhibitor 1 reactivator, plasminase/antiplasminase A2 complex, antithrombin III;Incidence of proximal deep venous thrombosis of the lower leg;

Secondary

MeasureTime frame
Length of stay in ICU;Mechanical ventilation time;The incidence of MODS;28?90-day survival curve;28 - day mortality;Incidence of pulmonary embolism;Expenses during ICU hospitalization;All - cause mortality in hospital;Thrombolysis diagram(TEG);

Countries

China

Contacts

Public ContactKang Yan

West China Hospital of Sichuan University

kangyan@scu.edu.cn+86 18980601566

Outcome results

None listed

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