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| Name | Class |
|---|---|
| Guangxi Wuzhou Pharmaceutical (GROUP) Co., Ltd. | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Incidence of distal DVT |
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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:
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.
Exclusion Criteria:
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Perioperative patients, spontaneous cerebral hemorrhage, acute ischemic cerebral infarction
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| Dongguan Chinese Medicine Hospital |
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Conventional treatment + Xueshuantong injection(lyophilized)
Distal deep venous thrombosis (DVT).
| Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) |
| Incidence of PTE | Pulmonary thromboembolism (PTE). | Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) |
| 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) |
| 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) |
| Mortality | Deaths of all causes. | Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS) |
| 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) |
| 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) |
| Dongguan |
| Guangdong |
| 523000 |
| China |
| Foshan Hospital of Traditional Chinese Medicine | Foshan | Guangdong | 528000 | China |
| Guangzhou Red Cross Hospital | Guangzhou | Guangdong | 510000 | China |
| The First Affiliated Hospital of Guangxi Medical University | Liuzhou | Guangxi | 545000 | China |
| The First People's Hospital of Nanning | Nanning | Guangxi | 530000 | China |
| The People's Hospital of Wuzhou | Wuzhou | Guangxi | 543000 | China |
| Wuzhou Red Cross Hospital | Wuzhou | Guangxi | 543000 | China |
| Yulin Second People's Hospital | Yulin | Guangxi | 537000 | China |
| Hebei General Hospital | Shijiazhuang | Hebei | 050000 | China |
| The Third Hospital of Changsha | Changsha | Hunan | 410000 | China |
| Jingjiang Chinese Medicine Hospital | Jingjiang | Jiangsu | 214500 | China |
| Qilu Hospital of Shandong University Dezhou Hospital | Dezhou | Shandong | 253000 | China |
| Liaocheng People's Hospital | Liaocheng | Shandong | 0635 252000 | China |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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