Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients
NCT ID: NCT06443905
Last Updated: 2024-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
21600 participants
OBSERVATIONAL
2023-08-01
2024-12-30
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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PNS_ONLY
Only Xueshuantong injection(lyophilized) is used after surgery
No interventions assigned to this group
NON_INT
No thrombus prophylaxis after surgery
No interventions assigned to this group
LMWH_ONLY
Only low molecular weight heparin(LMWH) is used after surgery
No interventions assigned to this group
PNS+LMWH
Xueshuantong injection (lyophilized) and low molecular weight heparin are used simultaneously after surgery
No interventions assigned to this group
ICH_CTL
Conventional treatment
No interventions assigned to this group
ICH_PNS
Conventional treatment + Xueshuantong injection (lyophilized)
No interventions assigned to this group
AIS_CTL
Conventional treatment
No interventions assigned to this group
AIS_PNS
Conventional treatment + Xueshuantong injection(lyophilized)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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);
18 Years
ALL
No
Sponsors
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Guangxi Wuzhou Pharmaceutical (GROUP) Co., Ltd.
UNKNOWN
China-Japan Friendship Hospital
OTHER
Responsible Party
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Wanmu Xie
chief physician
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Dongguan Chinese Medicine Hospital
Dongguan, Guangdong, China
Foshan Hospital of Traditional Chinese Medicine
Foshan, Guangdong, China
Guangzhou Red Cross Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi, China
The First People's Hospital of Nanning
Nanning, Guangxi, China
The People's Hospital of Wuzhou
Wuzhou, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Yulin Second People's Hospital
Yulin, Guangxi, China
Hebei General Hospital
Shijiazhuang, Hebei, China
The Third Hospital of Changsha
Changsha, Hunan, China
Jingjiang Chinese Medicine Hospital
Jingjiang, Jiangsu, China
Qilu Hospital of Shandong University Dezhou Hospital
Dezhou, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Countries
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Other Identifiers
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JVMID-2023101
Identifier Type: -
Identifier Source: org_study_id
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