Thromboembolism, Venous Thromboembolism (VTE)
Conditions
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)
Interventions
None listed
Sponsors
Guangxi Wuzhou Pharmaceutical (GROUP) Co., Ltd.
China-Japan Friendship Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of VTE | Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) | Incidence of venous thromboembolism (VTE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of distal DVT | Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) | Distal deep venous thrombosis (DVT). |
| Incidence of PTE | Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) | Pulmonary thromboembolism (PTE). |
| Incidence of symptomatic VTE | Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) | Symptomatic venous thromboembolism (VTE). |
| Incidence of proximal DVT | Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) | Proximal deep venous thrombosis (DVT). |
| Mortality | Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) | Deaths of all causes. |
| Wound healing time | Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) | Healing time after surgery |
| Length of stay | Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) | Time from admission to discharge |
| Incidence of non-symptomatic VTE | Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) | Non-symptomatic venous thromboembolism (VTE) |
Countries
China
Outcome results
None listed