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

NCT06443905 | Active Not Recruiting

• 1 other identifier: JVMID-2023101
• Study Type: observational
• Target: 21,600
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Venous Thromboembolism (VTE); Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Incidence of VTE

  Incidence of venous thromboembolism (VTE)

  Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)

Secondary Outcomes (8)

• Incidence of proximal DVT

  Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)

• Incidence of distal DVT

  Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)

• Incidence of PTE

  Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)

• Incidence of symptomatic VTE

  Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)

• Incidence of non-symptomatic VTE

  Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)

Study Arms (8)

PNS_ONLY

Only Xueshuantong injection(lyophilized) is used after surgery

NON_INT

No thrombus prophylaxis after surgery

LMWH_ONLY

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

PNS+LMWH

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

ICH_CTL

Conventional treatment

ICH_PNS

Conventional treatment + Xueshuantong injection (lyophilized)

AIS_CTL

Conventional treatment

AIS_PNS

Conventional treatment + Xueshuantong injection(lyophilized)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Perioperative patients, spontaneous cerebral hemorrhage, acute ischemic cerebral infarction

You may qualify if:

• 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:
• 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;
• 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;
• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• Guangxi Wuzhou Pharmaceutical (GROUP) Co., Ltd.: collaborator

Study Sites (14)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

Dongguan Chinese Medicine Hospital

Dongguan, Guangdong, 523000, China

Location

Foshan Hospital of Traditional Chinese Medicine

Foshan, Guangdong, 528000, China

Location

Guangzhou Red Cross Hospital

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital of Guangxi Medical University

Liuchow, Guangxi, 545000, China

Location

The First People's Hospital of Nanning

Nanning, Guangxi, 530000, China

Location

The People's Hospital of Wuzhou

Wuzhou, Guangxi, 543000, China

Location

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, 543000, China

Location

Yulin Second People's Hospital

Yulin, Guangxi, 537000, China

Location

Hebei General Hospital

Shijiazhuang, Hebei, 050000, China

Location

The Third Hospital of Changsha

Changsha, Hunan, 410000, China

Location

Jingjiang Chinese Medicine Hospital

Jingjiang, Jiangsu, 214500, China

Location

Qilu Hospital of Shandong University Dezhou Hospital

Dezhou, Shandong, 253000, China

Location

Liaocheng People's Hospital

Liaocheng, Shandong, 0635 252000, China

Location

MeSH Terms

Conditions

Venous Thromboembolism; Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: June 5, 2024
• Study Start: August 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-05

Locations

CN (14)