5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302478
• Other study ID #: KhonKaenU001
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2024
• Source: Khon Kaen University
• Contact: Wiphawadee Potisopha, Ph.D.
• Phone: +660954291592
• Email: wiphpo[@]kku.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: October 31, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nurse's Role
• Spinal Cord Diseases
• Spinal Cord Injuries
• Thromboembolism
• Venous Thromboembolism

Intervention

Behavioral:
• 5E program
Participants in the 5E program group will receive 7-day nursing interventions 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

Locations

Country	Name	City	State
Thailand	Chaiyaphum Hospital	Chaiyaphum

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of venous thromboembolism	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.	The day before implementing the intervention and at 7 days after implementing intervention
Secondary	Signs and symptoms of deep venous thrombosis and pulmonary embolism	The Well's Score for deep venous thrombosis (DVT) includes clinical parameters: active cancer or palliative (+1), paralysis (+1), recently bedridden for more than 3 days (+1), localized tenderness (+1), entire leg swelling (+1), calf swelling more than 3 cm compared with asymptomatic leg (+1), pitting edema (+1), previous DVT documented (+1), collateral superficial veins (non-varicose) (+1), and alternative diagnosis (-2).; The Modified Well's Score for pulmonary embolism (PE) includes the following criteria: clinical signs and symptoms of DVT (3); an alternative diagnosis is less likely than PE (3); a heart rate greater than 100 (1.5); immobilization for 3 or more consecutive days (1.5); previous objectively diagnosed PE or DVT (1.5); hemoptysis (1); and malignancy (1).	The day before implementing the intervention and Day 1 - Day 7 after implementing intervention
Secondary	Thigh and calf circumference	Thigh and calf circumferences will be measured in centimeters using the standardized measuring tape. The assistant researcher will record the results in the data record form.	The day before implementing the intervention and Day 1 - Day 7 after implementing intervention