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The Effect of Standardizing Procedures for SC Injections of LMWH on Patients With CVD

The Effect of Standardizing Procedures for Subcutaneous Injections of Low-molecular-weight Heparin on Patients With Cardiovascular Diseases: A Cluster Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06776159
Acronym
LMWH
Enrollment
180
Registered
2025-01-15
Start date
2025-06-24
Completion date
2027-04-30
Last updated
2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruise, CVD - Cardiovascular Disease, Pain

Keywords

LMWH injection

Brief 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.

Detailed description

This study examines the effect of standardized protocol in reducing complications for patients with cardiovascular disease.

Interventions

OTHERActive Control

Patients in the control group will receive the usual practice of subcutaneous LMWH injection administered by nurses.

OTHERStandardized injection protocol

Nurses administer LMWH according to the standardized evidence-based protocol.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The administrative staff, who will be responsible for data collection, will be masked for the group allocation during the whole process. The patients will be masked for the intervention purpose.

Intervention model description

Double-blinded, two-armed, clustered randomized controlled trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients who are in cardiac care units suffering from cardiovascular diseases prescribed with LMWH injections two times per day * Chinese

Exclusion criteria

* cognitively impaired * unconscious * refuse to participate

Design outcomes

Primary

MeasureTime frameDescription
Bruise size24 hours, 48 hours, 72 hoursThe bruising length and width will be measured by a ruler and the incidence of bruising will be recorded.
Pain levelImmediately after injection, 24 hours, 48 hours, 72 hoursPatients' 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.

Secondary

MeasureTime frameDescription
Patient ExperienceImmediately after receiving the injectiona Patient Experience Surveys to evaluate their perceived nurse's attitude
Communicative CompetenceImmediately before and after injectionCommunicative 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.

Countries

Hong Kong

Contacts

CONTACTFrankie CHEUNG
frankie.py.cheung@polyu.edu.hk852 2766 7991
CONTACTArkers Wong
arkers.wong@polyu.edu.hk852 3400 3805
PRINCIPAL_INVESTIGATORArkers Wong

The Hong Kong Polytechnic University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 19, 2026