Venous Thromboembolic DiseaseNCT04211181
CHIPs-VTE Study in Hospitalized Patients to Prevent Hospital-Acquired Venous Thromboembolism
A study testing The multifaceted interventions and Routine VTE prophylaxis in people with Venous Thromboembolic Disease and Pulmonary Embolism, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Although pharmacologic and mechanical methods to prevent VTE are safe, effective, cost-effective, and advocated by authoritative guidelines,many studies continue to demonstrate that these preventive methods are significantly underutilized, especially in China.A number of quality improvements (QI) program have been… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Venous Thromboembolic Disease, Pulmonary Embolism, Venous Thromboembolism
- What is being tested?
- The multifaceted interventions and Routine VTE prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,800 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged ≥14 years
- Have an expected hospital stay ≥72 hours for medical and/or surgical treatment
- Written informed consent
Who cannot join
- Inability to be followed-up at until 3 months after randomization
- Have participated in similar trials or are undergoing other clinical trials
- Refuse or are unable to give informed consent
- VTE identified on CTPA or lower extremity vein ultrasound at or any time before enrollment
- Requiring a full dose of anticoagulant treatment (e.g., recent VTE, atrial fibrillation).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Zhenguo Zhai, M.D. Ph.D
About this study
Official title: Effect on Thromboprophylaxis Among Hospitalized Patients Using a System-wide Multifaceted Quality Improvement Intervention: Rationale and Design for a Multicenter Cluster Randomized Clinical Trial in China
Although pharmacologic and mechanical methods to prevent VTE are safe, effective, cost-effective, and advocated by authoritative guidelines,many studies continue to demonstrate that these preventive methods are significantly underutilized, especially in China.A number of quality improvements (QI) program have been established in several countries or hospitals.However,no exit effective protocol has been demonstrated well enough or adequate to drive breakthrough levels of improvement. A reliable and practical QI that can support hospitals or physicians in China is warranted.To evaluate the multifaceted quality improvement intervention effect in clinical setting, we will conduct a cluster-randomized clinical trial among China PUlmonary Thromboembolism REgistry Study (CURES) group, aiming to test whether it's applicable to real-world practice in China.
A multicenter, two-arms, open-label clinical trial has been designed to determine whether the system-wide multifaceted intervention could increase the rate of at-risk participants who received prophylaxis (RP) and decrease the incidence of any hospital-associated VTE in 90 days during and after hospital admission. .Selected hospital will be regarded as a cluster and randomized into interventional or control group.In interventional group, eligible hospitalized patients will receive a variety of the multifaceted quality improvement(QI) interventions since admitted in hospital.In control group, patients will receive no more than common recommended care or an existing policy.The primary outcomes are the proportion of appropriate prophylaxis in hospitalized patients and the incidence of HA-VTE in 90 days after hospital admission.
Read the detailed description
Hospitals nationwide which have willingness to participate this study in CURES group will be selected. Each selected hospital will be regarded as a cluster and randomized into interventional or control group.
During the study period, eligible patients enrolled in hospitals assigned to interventional group will receive a variety of the multifaceted quality improvement(QI) interventions, including mandatory risk assessment, a computer alert(computer-based clinical decision support system and computerized reminders), strengthened education, and audit. Patients in hospitals assigned to control group will receive common recommended care only, or an existing policy.
- Conditions
- Venous Thromboembolic Disease, Pulmonary Embolism, Venous Thromboembolism, Deep Venous Thrombosis, Quality Improvement
- Being tested
- The multifaceted interventions, Routine VTE prophylaxis
- Keywords
- Quality improvement, Venous Thromboembolism, Hospital Associated-VTE
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The multifaceted interventionsOther
- An evidence-based clinical guideline and pathway in hospital.
- A series Written care protocols for the implementation of performance measures.
- A newly developed mobile application (mini-program) will be employed to facilitate venous thromboembolism (VTE) risk assessment and prophylaxis. Patients will scan a QR code to enroll in the program and be linked with their physician. Through the application, patients will complete standardized self-assessments of VTE risk, and physicians will receive periodic reminders indicating whether the assessment and prophylaxis orders have been completed.The application also provides educational modules and targeted messages for both patients and physicians, and enables interactive communication.
- A quality-control team will receive weekly feedback reports to verify whether all enrolled patients underwent appropriate prophylaxis.
Routine VTE prophylaxisOther
Patients randomized to the Routine VTE prophylaxis (Control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices
| Study group | Role | What they receive |
|---|---|---|
| The multifaceted QI interventions | Experimental | Hospitals randomized into experimental group will implement follow interventions including：the distribution of the guideline and pathway, a computer alert(computer-based clinical decision support system and computerized reminders),audit and feedback. Receives: Other: The multifaceted interventions |
| Routine VTE prophylaxis in local clinical practice | Active comparator | Patients in the routine VTE prophylaxis(control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices. Receives: Other: Routine VTE prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of appropriate prophylaxis rate during hospitalization
The proportion of appropriate prophylaxis is defined as the number of appropriate prophylaxis among the patients at risk of VTE and without corresponding contraindications.
Measured: 90 days after hospital admission
The proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE)
The incidence of HA-VTE is defined as the proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE)
Measured: 90 days after hospital admission
Secondary outcomes (2)
All-cause mortality
Proportion of participants who was dead(all-cause mortality)
Measured: 90 days after hospital admission
Proportion of complications related to the intervention
complications(i.e. major bleeding,minor bleeding, thrombocytopenia) related to the intervention
Measured: 90 days after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Aug 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Venous Thromboembolic DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenguo Zhai,MD,PhD, China-Japan Friendship Hospital
- Investigators
- Zhenguo Zhai, Doctor, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211181
- Sponsor's protocol ID
- CHIPs-VTE in inpatient
- Status last verified
- Sep 2025
- First submitted
- 8 Dec 2019
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piazza G, Rosenbaum EJ, Pendergast W, Jacobson JO, Pendleton RC, McLaren GD, Elliott CG, Stevens SM, Patton WF, Dabbagh O, Paterno MD, Catapane E, Li Z, Goldhaber SZ. Physician alerts to prevent symptomatic venous thromboembolism in hospitalized patients. Circulation. 2009 Apr 28;119(16):2196-201. doi: 10.1161/CIRCULATIONAHA.108.841197. Epub 2009 Apr 13.
PubMed 19364975Pai M, Lloyd NS, Cheng J, Thabane L, Spencer FA, Cook DJ, Haynes RB, Schunemann HJ, Douketis JD. Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial. Implement Sci. 2013 Jan 2;8:1. doi: 10.1186/1748-5908-8-1.
PubMed 23279972Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533.
PubMed 15758007Writing Group for the CHECKLIST-ICU Investigators and the Brazilian Research in Intensive Care Network (BRICNet); Cavalcanti AB, Bozza FA, Machado FR, Salluh JI, Campagnucci VP, Vendramim P, Guimaraes HP, Normilio-Silva K, Damiani LP, Romano E, Carrara F, Lubarino Diniz de Souza J, Silva AR, Ramos GV, Teixeira C, Brandao da Silva N, Chang CC, Angus DC, Berwanger O. Effect of a Quality Improvement Intervention With Daily Round Checklists, Goal Setting, and Clinician Prompting on Mortality of Critically Ill Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 12;315(14):1480-90. doi: 10.1001/jama.2016.3463.
PubMed 27115264Garcia DA, Highfill J, Finnerty K, Varoz E, McConkey S, Hutchinson K, Libby E. A prospective, controlled trial of a pharmacy-driven alert system to increase thromboprophylaxis rates in medical inpatients. Blood Coagul Fibrinolysis. 2009 Oct;20(7):541-5. doi: 10.1097/MBC.0b013e32832d6cfc.
PubMed 19584716Fontaine A, Mahe I, Bergmann JF, Fiessinger JN, Dhote R, Cohen P, Vinceneux P. Effectiveness of written guidelines on the appropriateness of thromboprophylaxis prescriptions for medical patients: a prospective randomized study. J Intern Med. 2006 Oct;260(4):369-76. doi: 10.1111/j.1365-2796.2006.01699.x.
PubMed 16961674Dong F, Zhen K, Zhang Z, Si C, Xia J, Zhang T, Xia L, Wang W, Jia C, Shan G, Zhai Z, Wang C; Chinese Prevention Strategy for Venous Thromboembolism (CHIPS-VTE) study group. Effect on thromboprophylaxis among hospitalized patients using a system-wide multifaceted quality improvement intervention: Rationale and design for a multicenter cluster randomized clinical trial in China. Am Heart J. 2020 Jul;225:44-54. doi: 10.1016/j.ahj.2020.04.020. Epub 2020 May 7.
PubMed 32474204
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Thromboprophylaxis Among Hospitalized Patients Using a System-wide Multifaceted Quality Improvement Intervention: Rationale and Design for a Multicenter Cluster Randomized Clinical Trial in China
- ClinicalTrials.gov ID
- NCT04211181
- Acronym / sponsor ID
- CHIPs-VTE in inpatient
- Conditions
- Venous Thromboembolic Disease, Pulmonary Embolism, Venous Thromboembolism, Deep Venous Thrombosis, Quality Improvement
- Keywords
- Quality improvement, Venous Thromboembolism, Hospital Associated-VTE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,800 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Dec 2019 (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.
Although pharmacologic and mechanical methods to prevent VTE are safe, effective, cost-effective, and advocated by authoritative guidelines,many studies continue to demonstrate that these preventive methods are significantly underutilized, especially in China.A number of quality improvements (QI) program have been established in several countries or hospitals.However,no exit effective protocol has been demonstrated well enough or adequate to drive breakthrough levels of improvement. A reliable and practical QI that can support hospitals or physicians in China is warranted.To evaluate the multifaceted quality improvement intervention effect in clinical setting, we will conduct a cluster-randomized clinical trial among China PUlmonary Thromboembolism REgistry Study (CURES) group, aiming to test whether it's applicable to real-world practice in China.
A multicenter, two-arms, open-label clinical trial has been designed to determine whether the system-wide multifaceted intervention could increase the rate of at-risk participants who received prophylaxis (RP) and decrease the incidence of any hospital-associated VTE in 90 days during and after hospital admission. .Selected hospital will be regarded as a cluster and randomized into interventional or control group.In interventional group, eligible hospitalized patients will receive a variety of the multifaceted quality improvement(QI) interventions since admitted in hospital.In control group, patients will receive no more than common recommended care or an existing policy.The primary outcomes are the proportion of appropriate prophylaxis in hospitalized patients and the incidence of HA-VTE in 90 days after hospital admission.
Detailed description
Hospitals nationwide which have willingness to participate this study in CURES group will be selected. Each selected hospital will be regarded as a cluster and randomized into interventional or control group.
During the study period, eligible patients enrolled in hospitals assigned to interventional group will receive a variety of the multifaceted quality improvement(QI) interventions, including mandatory risk assessment, a computer alert(computer-based clinical decision support system and computerized reminders), strengthened education, and audit. Patients in hospitals assigned to control group will receive common recommended care only, or an existing policy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The multifaceted QI interventions | Experimental | Other: The multifaceted interventionsHospitals randomized into experimental group will implement follow interventions including：the distribution of the guideline and pathway, a computer alert(computer-based clinical decision support system and computerized reminders),audit and feedback. |
| Routine VTE prophylaxis in local clinical practice | Active comparator | Other: Routine VTE prophylaxisPatients in the routine VTE prophylaxis(control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥14 years
- Have an expected hospital stay ≥72 hours for medical and/or surgical treatment
- Written informed consent
Key exclusion criteria (5 listed)
- Inability to be followed-up at until 3 months after randomization
- Have participated in similar trials or are undergoing other clinical trials
- Refuse or are unable to give informed consent
- VTE identified on CTPA or lower extremity vein ultrasound at or any time before enrollment
- Requiring a full dose of anticoagulant treatment (e.g., recent VTE, atrial fibrillation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The multifaceted interventions1. An evidence-based clinical guideline and pathway in hospital. 2. A series Written care protocols for the implementation of performance measures. 3. A newly developed mobile application (mini-program) will be employed to facilitate venous thromboembolism (VTE) risk assessment and prophylaxis. Patients will scan a QR code to enroll in the program and be linked with their physician. Through the application, patients will complete standardized self-assessments of VTE risk, and physicians will receive periodic reminders indicating whether the assessment and prophylaxis orders have been completed.The application also provides educational modules and targeted messages for both patients and physicians, and enables interactive communication. 4. A quality-control team will receive weekly feedback reports to verify whether all enrolled patients underwent appropriate prophylaxis. | Other | The multifaceted QI interventions |
| Routine VTE prophylaxisPatients randomized to the Routine VTE prophylaxis (Control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices | Other | Routine VTE prophylaxis in local clinical practice |
Primary outcome
Proportion of appropriate prophylaxis rate during hospitalization
Time frame: 90 days after hospital admission
The proportion of appropriate prophylaxis is defined as the number of appropriate prophylaxis among the patients at risk of VTE and without corresponding contraindications.
The proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE)
Time frame: 90 days after hospital admission
The incidence of HA-VTE is defined as the proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE)
2 secondary outcomes
All-cause mortality
Time frame: 90 days after hospital admission
Proportion of complications related to the intervention
Time frame: 90 days after hospital admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 19364975Piazza G, Rosenbaum EJ, Pendergast W, Jacobson JO, Pendleton RC, McLaren GD, Elliott CG, Stevens SM, Patton WF, Dabbagh O, Paterno MD, Catapane E, Li Z, Goldhaber SZ. Physician alerts to prevent symptomatic venous thromboembolism in hospitalized patients. Circulation. 2009 Apr 28;119(16):2196-201. doi: 10.1161/CIRCULATIONAHA.108.841197. Epub 2009 Apr 13.
- Background: PubMed 23279972Pai M, Lloyd NS, Cheng J, Thabane L, Spencer FA, Cook DJ, Haynes RB, Schunemann HJ, Douketis JD. Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial. Implement Sci. 2013 Jan 2;8:1. doi: 10.1186/1748-5908-8-1.
- Background: PubMed 15758007Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533.
- Background: PubMed 27115264Writing Group for the CHECKLIST-ICU Investigators and the Brazilian Research in Intensive Care Network (BRICNet); Cavalcanti AB, Bozza FA, Machado FR, Salluh JI, Campagnucci VP, Vendramim P, Guimaraes HP, Normilio-Silva K, Damiani LP, Romano E, Carrara F, Lubarino Diniz de Souza J, Silva AR, Ramos GV, Teixeira C, Brandao da Silva N, Chang CC, Angus DC, Berwanger O. Effect of a Quality Improvement Intervention With Daily Round Checklists, Goal Setting, and Clinician Prompting on Mortality of Critically Ill Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 12;315(14):1480-90. doi: 10.1001/jama.2016.3463.
- Background: PubMed 19584716Garcia DA, Highfill J, Finnerty K, Varoz E, McConkey S, Hutchinson K, Libby E. A prospective, controlled trial of a pharmacy-driven alert system to increase thromboprophylaxis rates in medical inpatients. Blood Coagul Fibrinolysis. 2009 Oct;20(7):541-5. doi: 10.1097/MBC.0b013e32832d6cfc.
- Background: PubMed 16961674Fontaine A, Mahe I, Bergmann JF, Fiessinger JN, Dhote R, Cohen P, Vinceneux P. Effectiveness of written guidelines on the appropriateness of thromboprophylaxis prescriptions for medical patients: a prospective randomized study. J Intern Med. 2006 Oct;260(4):369-76. doi: 10.1111/j.1365-2796.2006.01699.x.
- Derived from this study: PubMed 32474204Dong F, Zhen K, Zhang Z, Si C, Xia J, Zhang T, Xia L, Wang W, Jia C, Shan G, Zhai Z, Wang C; Chinese Prevention Strategy for Venous Thromboembolism (CHIPS-VTE) study group. Effect on thromboprophylaxis among hospitalized patients using a system-wide multifaceted quality improvement intervention: Rationale and design for a multicenter cluster randomized clinical trial in China. Am Heart J. 2020 Jul;225:44-54. doi: 10.1016/j.ahj.2020.04.020. Epub 2020 May 7.
- Individual participant dataSharing planned: No
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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.
Zhenguo Zhai, Doctor principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The multifaceted interventions and Routine VTE prophylaxis in people with Venous Thromboembolic Disease and Pulmonary Embolism, run by China-Japan Friendship Hospital at 1 site 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenguo Zhai, Doctor (86-10-84206265, zhaizhenguo2011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of appropriate prophylaxis rate during hospitalization (time frame: 90 days after hospital admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04211181, which also lists 7 linked publications.
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 17 Sep 2025.