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

NCT06776159 | Recruiting

• 2 other identifiers: 20250301CHEUNGPuiYu
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

CVD - Cardiovascular Disease; Bruise; Pain

Keywords

LMWH injection

Outcome Measures

Primary Outcomes (2)

• Bruising

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

  24 hours, 48 hours, 72 hours

• Pain

  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.

  Immediately after injection, 24 hours, 48 hours, 72 hours

Secondary Outcomes (2)

• Patient Experience

  Immediately after receiving the injection

• Communicative Competence

  Immediately before and after injection

Study Arms (2)

Active Control

ACTIVE COMPARATOR

The control group participants will receive the usual practice of subcutaneous LMWH injection administered by nurses.

Other: Active Control

Standardized injection protocol

EXPERIMENTAL

The intervention group participants will receive standardized LMWH injection administered by nurses.

Other: Standardized injection protocol

Interventions

Active Control OTHER

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

Active Control

Standardized injection protocol OTHER

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

Standardized injection protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• cognitively impaired
• unconscious
• refuse to participate

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Hospital Authority, Hong Kong

Hong Kong, 00000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Contusions; Pain

Condition Hierarchy (Ancestors)

Wounds, Nonpenetrating; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arkers Wong

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frankie CHEUNG

CONTACT

852 2766 7991; frankie.py.cheung@polyu.edu.hk

Arkers Wong

CONTACT

852 3400 3805; arkers.wong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Practice

Model Details: Double-blinded, two-armed, clustered randomized controlled trial.

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 15, 2025
• Study Start: June 24, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

HK (1)