CVD - Cardiovascular DiseaseLMWHNCT06776159
The Effect of Standardizing Procedures for SC Injections of LMWH on Patients With CVD
A study testing Standardized injection protocol in people with CVD - Cardiovascular Disease and Bruise, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Improper subcutaneous administration of LMWH may cause complications at the injection site. Standardized protocol for subcutaneous LMWH injections in patient with cardiovascular diseases is warranted to ensure consistent best practices in clinical settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CVD - Cardiovascular Disease, Bruise, Pain
- What is being tested?
- Standardized injection protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Jun 2025to 30 Apr 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are in cardiac care units suffering from cardiovascular diseases prescribed with LMWH injections two times per day
- Chinese
Who cannot join
- cognitively impaired
- unconscious
- refuse to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hospital Authority, Hong Kong
Hong Kong, 00000
About this study
Official title: The Effect of Standardizing Procedures for Subcutaneous Injections of Low-molecular-weight Heparin on Patients With Cardiovascular Diseases: A Cluster Randomized Controlled Trial
Improper subcutaneous administration of LMWH may cause complications at the injection site. Standardized protocol for subcutaneous LMWH injections in patient with cardiovascular diseases is warranted to ensure consistent best practices in clinical settings.
Read the detailed description
This study examines the effect of standardized protocol in reducing complications for patients with cardiovascular disease.
- Conditions
- CVD - Cardiovascular Disease, Bruise, Pain
- Being tested
- Active Control, Standardized injection protocol
- Keywords
- LMWH injection
- Medical subject headings
- Cardiovascular Diseases, Contusions, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ControlOther
Patients in the control group will receive the usual practice of subcutaneous LMWH injection administered by nurses.
Standardized injection protocolOther
Nurses administer LMWH according to the standardized evidence-based protocol.
| Study group | Role | What they receive |
|---|---|---|
| Active Control | Active comparator | The control group participants will receive the usual practice of subcutaneous LMWH injection administered by nurses. Receives: Other: Active Control |
| Standardized injection protocol | Experimental | The intervention group participants will receive standardized LMWH injection administered by nurses. Receives: Other: Standardized injection protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruise size
The bruising length and width will be measured by a ruler and the incidence of bruising will be recorded.
Measured: 24 hours, 48 hours, 72 hours
Pain level
Patients' pain levels are assessed using the Numeric Rating Scale: from o to 10, with "10" representatin the worst outcome and with '0' representing the best outcome.
Measured: Immediately after injection, 24 hours, 48 hours, 72 hours
Secondary outcomes (2)
Patient Experience
a Patient Experience Surveys to evaluate their perceived nurse's attitude
Measured: Immediately after receiving the injection
Communicative Competence
Communicative Competence Scale consists of 36 items across five dimensions (General Competence, Empathy Affiliation/Support, Behavioural Flexibility, and Social Relaxation), using a 5-point Likert scales ranging from strongly agree to strongly disagree (coded from 1 to 5). Higher the score means worse the outcome.
Measured: Immediately before and after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start24 Jun 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVD - Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, two-armed, clustered randomized controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHEUNG Pui Yu Frankie, The Hong Kong Polytechnic University
- Investigators
- Arkers Wong, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776159
- Sponsor's protocol ID
- 20250301
- Other IDs
- CHEUNGPuiYu
- Acronym
- LMWH
- Status last verified
- Sep 2025
- First submitted
- 30 Dec 2024
- Last updated
- 18 Sep 2026
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Standardizing Procedures for Subcutaneous Injections of Low-molecular-weight Heparin on Patients With Cardiovascular Diseases: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06776159
- Acronym / sponsor ID
- LMWH / 20250301
- Conditions
- CVD - Cardiovascular Disease, Bruise, Pain
- Keywords
- LMWH injection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 15 Jan 2025 (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.
Improper subcutaneous administration of LMWH may cause complications at the injection site. Standardized protocol for subcutaneous LMWH injections in patient with cardiovascular diseases is warranted to ensure consistent best practices in clinical settings.
Detailed description
This study examines the effect of standardized protocol in reducing complications for patients with cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, two-armed, clustered randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Active Control | Active comparator | Other: Active ControlThe control group participants will receive the usual practice of subcutaneous LMWH injection administered by nurses. |
| Standardized injection protocol | Experimental | Other: Standardized injection protocolThe intervention group participants will receive standardized LMWH injection administered by nurses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who are in cardiac care units suffering from cardiovascular diseases prescribed with LMWH injections two times per day
- Chinese
Key exclusion criteria (3 listed)
- cognitively impaired
- unconscious
- refuse to participate
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 |
|---|---|---|
| Active ControlPatients in the control group will receive the usual practice of subcutaneous LMWH injection administered by nurses. | Other | Active Control |
| Standardized injection protocolNurses administer LMWH according to the standardized evidence-based protocol. | Other | Standardized injection protocol |
Primary outcome
Bruise size
Time frame: 24 hours, 48 hours, 72 hours
The bruising length and width will be measured by a ruler and the incidence of bruising will be recorded.
Pain level
Time frame: Immediately after injection, 24 hours, 48 hours, 72 hours
Patients' pain levels are assessed using the Numeric Rating Scale: from o to 10, with "10" representatin the worst outcome and with '0' representing the best outcome.
2 secondary outcomes
Patient Experience
Time frame: Immediately after receiving the injection
Communicative Competence
Time frame: Immediately before and after injection
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 18 Sep 2026.
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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.
Arkers Wong principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized injection protocol in people with CVD - Cardiovascular Disease and Bruise, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 2 inclusion and 3 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 18 Sep 2026. 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 Hong Kong. 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 Frankie CHEUNG (852 2766 7991, frankie.py.cheung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruise size (time frame: 24 hours, 48 hours, 72 hours). 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?
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 18 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.