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NCT Number: NCT06776159

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

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.

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Key information

Conditions

CVD - Cardiovascular Disease Bruise Cardiovascular Diseases Contusions Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Authority, Hong Kong

Hong Kong, 00000

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Active Control

Other

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

Standardized injection protocol

Other

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

Primary outcomes

  1. Bruising

    Time frame: 24 hours, 48 hours, 72 hours

    The bruising diameter will be measured by a ruler and the incidence of bruising will be recorded.

  2. Pain

    Time frame: Immediately after injection, 24 hours, 48 hours, 72 hours

    Patients' pain levels are assessed using the Verbal Descriptor Scale: 'severe pain,' 'moderate pain,' 'mild pain,' and 'no pain.' 'Severe pain' indicates the worst outcome, followed by 'moderate pain,' then 'mild pain,' with 'no pain' representing the best outcome.

Secondary outcomes

  1. Patient Experience

    Time frame: Immediately after receiving the injection

    a Patient Experience Surveys to evaluate their perceived nurse's attitude

  2. Communicative Competence

    Time frame: Immediately before and after injection

    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.

Study contacts

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

Arkers Wong

CONTACT

[email protected]

852 3400 3805

Frankie CHEUNG

CONTACT

[email protected]

852 2766 7991

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Acronym: LMWH

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
Sep 11, 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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