Skip to main content
Clinical Trials/NCT06302478
NCT06302478UnknownNot Applicable

Effects of a Venous Thromboembolism Prevention Program on the Occurrence of Venous Thromboembolism in Patients With Spinal Cord Disorders

Khon Kaen University1 site in 1 country42 target enrollmentStarted: March 12, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
42
Locations
1
Primary Endpoint
The rate of venous thromboembolism

Study Overview

Brief Summary

The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are:

  • Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care?
  • Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care?
  • Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different?

Participants in the intervention group will receive the 5E program, including

  • Education: health education regarding venous thromboembolism prevention
  • Elevation: leg elevation of 10-20 degrees
  • Exercise: ankle exercises
  • Enough fluid: adequate fluid uptake
  • Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Caprini scores of 5-8 and >8
  • •Able to communicate in the Thai language
  • •Willing to participate in this study

Exclusion Criteria

  • •Alteration of consciousness
  • •Experiencing complications, including neurogenic shock and autonomic dysreflexia
  • •Being pregnant
  • •Having fluid restriction

Arms & Interventions

5E Program

Experimental

Participants in the 5E program group will receive 7-day nursing interventions.

Intervention: 5E program (Behavioral)

Usual Care

No Intervention

Participants in the control group will receive 7-day usual care interventions, including health education regarding signs and symptoms of venous thromboembolism and IPC use if the participants experienced muscle power as grade 0.

Outcomes

Primary Outcomes

The rate of venous thromboembolism

Time Frame: The day before implementing the intervention and at 7 days after implementing intervention

The diagnosis of venous thromboembolism is confirmed by a Doppler ultrasound scan of the femoral vein and popliteal vein by a physician working at the study site. The physician will record the results in the data record form.

Secondary Outcomes

  • Thigh and calf circumference(The day before implementing the intervention and Day 1 - Day 7 after implementing intervention)
  • Signs and symptoms of deep venous thrombosis and pulmonary embolism(The day before implementing the intervention and Day 1 - Day 7 after implementing intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wiphawadee Potisopha

Principle Investigator

Khon Kaen University

Study Sites (1)

Loading locations...

Similar Trials