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NCT Number: NCT04211181

CHIPs-VTE Study in Hospitalized Patients to Prevent Hospital-Acquired Venous Thromboembolism

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.

Recruiting

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Zhenguo Zhai, M.D. Ph.D

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥14 years
  • Have an expected hospital stay ≥72 hours for medical and/or surgical treatment
  • Written informed consent

Exclusion criteria

  • 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).

Treatment and study plan

The multifaceted interventions

Other
  • 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 prophylaxis

Other

Patients randomized to the Routine VTE prophylaxis (Control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. All-cause mortality

    Time frame: 90 days after hospital admission

    Proportion of participants who was dead(all-cause mortality)

  2. Proportion of complications related to the intervention

    Time frame: 90 days after hospital admission

    complications(i.e. major bleeding,minor bleeding, thrombocytopenia) related to the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenguo Zhai, Doctor

CONTACT

[email protected]

86-10-84206265

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2019
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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