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

Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06443905
• Other study ID #: JVMID-2023101
• Status: Active, not recruiting
• Start date: August 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: China-Japan Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21600
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism
• Venous Thromboembolism (VTE)

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing
China	The Third Hospital of Changsha	Changsha	Hunan
China	Qilu Hospital of Shandong University Dezhou Hospital	Dezhou	Shandong
China	Dongguan Chinese Medicine Hospital	Dongguan	Guangdong
China	Foshan Hospital of Traditional Chinese Medicine	Foshan	Guangdong
China	Guangzhou Red Cross Hospital	Guangzhou	Guangdong
China	Jingjiang Chinese Medicine Hospital	Jingjiang	Jiangsu
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	The First Affiliated Hospital of Guangxi Medical University	Liuzhou	Guangxi
China	The First People's Hospital of Nanning	Nanning	Guangxi
China	Hebei General Hospital	Shijiazhuang	Hebei
China	The People's Hospital of Wuzhou	Wuzhou	Guangxi
China	Wuzhou Red Cross Hospital	Wuzhou	Guangxi
China	Yulin Second People's Hospital	Yulin	Guangxi

Sponsors (2)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital	Guangxi Wuzhou Pharmaceutical (GROUP) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of proximal DVT	Proximal deep venous thrombosis (DVT).	Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Secondary	Incidence of distal DVT	Distal deep venous thrombosis (DVT).	Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Secondary	Incidence of PTE	Pulmonary thromboembolism (PTE).	Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Secondary	Incidence of symptomatic VTE	Symptomatic venous thromboembolism (VTE).	Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Secondary	Incidence of non-symptomatic VTE	Non-symptomatic venous thromboembolism (VTE)	Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Secondary	Mortality	Deaths of all causes.	Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Secondary	Wound healing time	Healing time after surgery	Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Secondary	Length of stay	Time from admission to discharge	Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)