Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients

China-Japan Friendship Hospital

Status: Active, not recruiting

Conditions: Thromboembolism; Venous Thromboembolism (VTE)

Study type: Observational

Funder types: Other

Identifiers

NCT06443905

JVMID-2023101

Details and patient eligibility

About

The purpose of this study is to explore the efficacy, safety and cost-effectiveness of Xueshuantong (lyophilized) for the prevention of venous thromboembolism (VTE) in patients at risk of bleeding.

Full description

This is a non-randomized, observational study.

This study primarily aims to investigate the efficacy, safety, and cost-effectiveness of using Xueshuantong injection (lyophilized) for preventing venous thromboembolism (VTE) in patients susceptible to bleeding. The subjects of the study comprise patients during the perioperative period (undergoing procedures lasting 45 minutes or longer), patients with a confirmed spontaneous cerebral hemorrhage (ICH), and patients with a confirmed acute ischemic stroke (AIS).

Additional objectives of this study including:

1. to evaluate the possible dose-dependency of Xueshuantong injection (lyophilized);
2. to evaluate the impact in coagulation function after administration of Xueshuantong injection (lyophilized)

Enrollment: 21,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women of ≥18 year old;

• Hospitalized between Jan 1, 2016 and Aug. 1, 2023;

• Received intravenous (IV) Xueshuantong (lyophilized) for ≥3 days;

• Who also meet one of the following criteria:

  1. Perioperative patients:

     Performed any of the following surgical procedures (≥ 45 minutes in duration) during hospitalization- general surgery, orthopedic surgery, obstetrics and gynecology surgery, neurosurgery, urology surgery, cardiothoracic surgery, obesity surgery or cancer surgery;

  2. Hospitalization due to acute spontaneous cerebral hemorrhage:

     Diagnosed as cerebral hemorrhage (acute/subacute), or subarachnoid hemorrhage, with clinical manifestations such as conscious disturbance, dyskinesia, or sensory dysfunction. Presence of cerebral hemorrhage was confirmed by imaging;

  3. Hospitalization due to acute ischemic stroke:

Diagnosed as ischemic stroke, ischemic stroke (acute/subacute), cerebral infarction, or cerebral infarction (acute/subacute), acute stage or subacute stage of ischemic stroke, with clinical manifestations such as disturbance of consciousness, motor dysfunction, or sensory dysfunction. Presence of cerebral hemorrhage was confirmed by imaging.

Exclusion criteria

• Received any traditional Chinese medicine (TCM) that contains total saponins of panax notoginseseng (PNS) other than Xueshuantong (lyophilized);
• Females who are pregnant or breast-feeding;
• Diagnosed venous thromboembolism occurred before enrollment;
• Received intravenous thrombolytic therapy for other reasons during hospitalization;
• Received prophylactic or therapeutic doses of anticoagulants after major surgery;
• Placed vena cava filters for VTE prophylaxis before surgery;
• Received therapeutic dose of anticoagulants during the patient's hospital stay (AIS patients);

Trial design

21,600 participants in 8 patient groups

PNS_ONLY

Description:

Only Xueshuantong injection(lyophilized) is used after surgery

NON_INT

Description:

No thrombus prophylaxis after surgery

LMWH_ONLY

Description:

Only low molecular weight heparin(LMWH) is used after surgery

PNS+LMWH

Description:

Xueshuantong injection (lyophilized) and low molecular weight heparin are used simultaneously after surgery

ICH_CTL

Description:

Conventional treatment

ICH_PNS

Description:

Conventional treatment + Xueshuantong injection (lyophilized)

AIS_CTL

Description:

Conventional treatment

AIS_PNS

Description:

Conventional treatment + Xueshuantong injection(lyophilized)