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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
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005297
Enrollment
Unknown
Registered
2021-09-10
Start date
2021-09-15
Completion date
Unknown
Last updated
2023-02-20

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) 18 years = age =80 years ?. Actual body weight =45kg; ? The estimated length of ICU stay is = 72 hours (4) Sign informed consent

Exclusion criteria

Exclusion criteria: ? Neurosurgery in the last three months (2) Ischemic stroke occurred within the last 3 months (3) Intracranial hemorrhage within the last 3 months (4) Systolic blood pressure =180mm Hg, diastolic blood pressure =110mm Hg, or vasoactive drug infusion was required for more than 12 hours 5) Massive bleeding in the past week ? Abnormal coagulation during screening: INR=2 times the upper limit of normal value, or APTT=2 times the normal value. G. Thrombocytopenia at screening: platelet count =75× 109/L8 ? Other Heparin contraindications (e.g. heparin-induced thrombocytopenia, pregnancy, lactation) Ultrasonography of lower limbs should not be performed (e.g. bilateral above-knee amputation or severe distal lower limb burns). (10) Limited life support, life expectancy = 14 days, or palliative care Contamination (e.g., use of low molecular weight heparin 3 times after admission to ICU) (12) Lack of informed consent (13) Blood products are contraindicated

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Public ContactYan Kang

West China Hospital of Sichuan University

kangyan@scu.edu.cn18980601566

Outcome results

None listed

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