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A randomized controlled clinical study of different doses of low molecular weight heparin for the prevention of thromboembolism in patients with sepsis

A randomized controlled clinical study of different doses of low molecular weight heparin for the prevention of thromboembolism in patients with sepsis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082589
Enrollment
Unknown
Registered
2024-04-01
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Sepsis and thromboembolism

Interventions

High-dose group:Subcutaneous injection of enoxaparin sodium within 24 hours.The dosage of enoxaparin was adjusted according to patients' creatinine clearance (CrCl).With a CrCl>30ml/min, enoxaparin wa
CrCl15-30ml/min was given enoxaparin 0.5mg/kgBID.In the course of treatment, patients with CrCl30ml/min, enoxaparin was given 1mg/kg once daily (QD) or 0.5mg/kgBID
CrCl15-30ml/min was given 0.5mg/kgQD with enoxaparin.In the course of treatment, patients with CrCl<15ml/min should stop using low molecular weight heparin, and clinicians should decide whether to con

Sponsors

Jiangdu People's Hospital affiliated to Yangzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Over 18 years of age;Sepsis (Sepsis 3.0 criteria) within 24 hours of diagnosis (uncontrolled host response to infection with life-threatening organ dysfunction).For patients with infection or suspected infection in ICU, when SOFA score is =2, the diagnosis is Sepsis).The patient or legal guardian signed the informed consent voluntarily (signed within 24h after enrollment);High risk of thrombosis: ?IMPROVE score =4 points or 2-3 points combined with D-dimer =500ng/ml.?ICU-VTE score > 8 points.Either (1) or (2) can be included in the study.

Exclusion criteria

Exclusion criteria: Pregnant or lactating women;Patients using anticoagulants within 48 hours;Patients with active bleeding;Patients with high blood risk, such as cerebral hemorrhage, massive cerebral infarction, aneurysm, vascular malformation, severe craniocerebral trauma, recent bleeding history, and receiving dual antiplatelet therapy;Patients with severe coagulation dysfunction (APTT=55 or INR=2) or platelet 1.5 or severe renal failure with CrCl<15ml/min;Patients who have declined to enroll or who have been enrolled in other clinical studies;Patients with pre-existing thrombosis at enrollment.

Design outcomes

Secondary

MeasureTime frame
28-day case fatality rate;Anti-Xa and ATIII;IL-6;IL-10;Polysaccharide coating;ICU mortality;Cumulative dose and duration of vasoactive drug use during ICU stay;ICU mechanical ventilation rate, use days, no mechanical ventilation days within 30 days;Length of ICU stay and total length of stay;IL-8;TNF-a;WBC;

Primary

MeasureTime frame
Thromboembolism incidence;

Countries

China

Contacts

Public ContactChen Qihong

Jiangdu People's Hospital affiliated to Yangzhou University

chenqihong00@163.com+86 180 5106 3567

Outcome results

None listed

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