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Clinical Trials/NCT06302478
NCT06302478
Recruiting
Not 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 enrollmentMarch 12, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venous Thromboembolism
Sponsor
Khon Kaen University
Enrollment
42
Locations
1
Primary Endpoint
The rate of venous thromboembolism
Status
Recruiting
Last Updated
2 years ago

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
Registry
clinicaltrials.gov
Start Date
March 12, 2024
End Date
October 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wiphawadee Potisopha

Principle Investigator

Khon Kaen University

Eligibility Criteria

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

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)

Study Sites (1)

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