Clinical trial NCT06443905: Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients
Official title: Efficacy, Safety and Cost-effectiveness of Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients at Risk of Bleeding: a Real-world Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Venous Thromboembolism (VTE)
Thromboembolism
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Guangxi Wuzhou Pharmaceutical (GROUP) Co., Ltd.
First posted: 2024-06-05
Enrollment: 21600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Perioperative patients, spontaneous cerebral hemorrhage, acute ischemic cerebral infarction

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.

Detailed 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)

Eligibility criteria: 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);

Primary outcomes:
measure: Incidence of VTE
timeFrame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Secondary outcomes:
measure: Incidence of proximal DVT
timeFrame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
measure: Incidence of distal DVT
timeFrame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
measure: Incidence of PTE
timeFrame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
measure: Incidence of symptomatic VTE
timeFrame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
measure: Incidence of non-symptomatic VTE
timeFrame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
measure: Mortality
timeFrame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
measure: Wound healing time
timeFrame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
measure: Length of stay
timeFrame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Dongguan
country: China
facility: Dongguan Chinese Medicine Hospital
state: Guangdong
city: Foshan
country: China
facility: Foshan Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Red Cross Hospital
state: Guangdong
city: Liuzhou
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: The First People's Hospital of Nanning
state: Guangxi
city: Wuzhou
country: China
facility: The People's Hospital of Wuzhou
state: Guangxi
city: Wuzhou
country: China
facility: Wuzhou Red Cross Hospital
state: Guangxi
city: Yulin
country: China
facility: Yulin Second People's Hospital
state: Guangxi
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Changsha
country: China
facility: The Third Hospital of Changsha
state: Hunan
city: Jingjiang
country: China
facility: Jingjiang Chinese Medicine Hospital
state: Jiangsu
city: Dezhou
country: China
facility: Qilu Hospital of Shandong University Dezhou Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
Study officials:
References: