Venous Thromboembolism (VTE)NCT06443905
Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients
An observational study of Venous Thromboembolism (VTE) and Thromboembolism, run by China-Japan Friendship Hospital at 14 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism (VTE), Thromboembolism
- Type of treatment
- Injection or infusion
- How many people
- 21,600 participants
- Where
- 14 sitesChina
- Study dates
- 1 Aug 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Perioperative patients, spontaneous cerebral hemorrhage, acute ischemic cerebral infarction
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000
The Third Hospital of Changsha
Changsha, Hunan, 410000
Qilu Hospital of Shandong University Dezhou Hospital
Dezhou, Shandong, 253000
Dongguan Chinese Medicine Hospital
Dongguan, Guangdong, 523000
Foshan Hospital of Traditional Chinese Medicine
Foshan, Guangdong, 528000
Guangzhou Red Cross Hospital
Guangzhou, Guangdong, 510000
Jingjiang Chinese Medicine Hospital
Jingjiang, Jiangsu, 214500
Liaocheng People's Hospital
Liaocheng, Shandong, 0635 252000
The First Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi, 545000
The First People's Hospital of Nanning
Nanning, Guangxi, 530000
Hebei General Hospital
Shijiazhuang, Hebei, 050000
The People's Hospital of Wuzhou
Wuzhou, Guangxi, 543000
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543000
Yulin Second People's Hospital
Yulin, Guangxi, 537000
About this study
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
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.
Read the 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:
- to evaluate the possible dose-dependency of Xueshuantong injection (lyophilized);
- to evaluate the impact in coagulation function after administration of Xueshuantong injection (lyophilized)
- Conditions
- Venous Thromboembolism (VTE), Thromboembolism
- Medical subject headings
- Venous Thromboembolism, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Conventional treatment + Xueshuantong injection(lyophilized) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of VTE
Incidence of venous thromboembolism (VTE)
Measured: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Secondary outcomes (8)
Incidence of proximal DVT
Proximal deep venous thrombosis (DVT).
Measured: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Incidence of distal DVT
Distal deep venous thrombosis (DVT).
Measured: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Incidence of PTE
Pulmonary thromboembolism (PTE).
Measured: 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).
Measured: 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)
Measured: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Mortality
Deaths of all causes.
Measured: 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
Measured: 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
Measured: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Aug 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangxi Wuzhou Pharmaceutical (GROUP) Co., Ltd.
- Responsible party
- Principal investigator, Wanmu Xie, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443905
- Sponsor's protocol ID
- JVMID-2023101
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06443905
- Acronym / sponsor ID
- JVMID-2023101
- Conditions
- Venous Thromboembolism (VTE), Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21,600 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Guangxi Wuzhou Pharmaceutical (GROUP) Co., Ltd.
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to evaluate the possible dose-dependency of Xueshuantong injection (lyophilized);
- to evaluate the impact in coagulation function after administration of Xueshuantong injection (lyophilized)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 | – | –Conventional treatment + Xueshuantong injection(lyophilized) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Perioperative patients, spontaneous cerebral hemorrhage, acute ischemic cerebral infarction
Key inclusion criteria (10 listed)
- 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:
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of VTE
Time frame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Incidence of venous thromboembolism (VTE)
8 secondary outcomes
Incidence of proximal DVT
Time frame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Incidence of distal DVT
Time frame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Incidence of PTE
Time frame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Incidence of symptomatic VTE
Time frame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Incidence of non-symptomatic VTE
Time frame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Mortality
Time frame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Wound healing time
Time frame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Length of stay
Time frame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism (VTE) and Thromboembolism, run by China-Japan Friendship Hospital at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of VTE (time frame: Within 14 days after admission (perioperative), within 14 days after admission (SCH), within 7 days after admission (AIS)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.