Venous ThromboembolismNCT06302478
5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders
A study testing 5E program in people with Venous Thromboembolism and Spinal Cord Diseases, run by Khon Kaen University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Spinal Cord Diseases, Spinal Cord Injuries
- What is being tested?
- 5E program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteThailand
- Study dates
- 12 Mar 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caprini scores of 5-8 and >8
- Able to communicate in the Thai language
- Willing to participate in this study
Who cannot join
- Alteration of consciousness
- Experiencing complications, including neurogenic shock and autonomic dysreflexia
- Being pregnant
- Having fluid restriction
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chaiyaphum Hospital
Chaiyaphum, 36000
Suchada Chindamart, BNS, +66619411828, suchada.chi@kkumail.com
About this study
Official title: Effects of a Venous Thromboembolism Prevention Program on the Occurrence of Venous Thromboembolism in Patients With Spinal Cord Disorders
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?
Read more
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
- Being tested
- 5E program
- Medical subject headings
- Venous Thromboembolism, Spinal Cord Diseases, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5E programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 5E Program | Experimental | Participants in the 5E program group will receive 7-day nursing interventions. Receives: Behavioral: 5E program |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The day before implementing the intervention and at 7 days after implementing intervention
Secondary outcomes (2)
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).
Measured: The day before implementing the intervention and Day 1 - Day 7 after implementing intervention
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.
Measured: The day before implementing the intervention and Day 1 - Day 7 after implementing intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start12 Mar 2024
- Primary completion30 May 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A quasi-experimental research (two group pretest-posttest design)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wiphawadee Potisopha, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302478
- Sponsor's protocol ID
- KhonKaenU001
- Status last verified
- Mar 2024
- First submitted
- 21 Jan 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Venous Thromboembolism Prevention Program on the Occurrence of Venous Thromboembolism in Patients With Spinal Cord Disorders
- ClinicalTrials.gov ID
- NCT06302478
- Acronym / sponsor ID
- KhonKaenU001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A quasi-experimental research (two group pretest-posttest design)
| Arm | Type | Receives |
|---|---|---|
| 5E Program | Experimental | Behavioral: 5E programParticipants in the 5E program group will receive 7-day nursing interventions. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Caprini scores of 5-8 and >8
- Able to communicate in the Thai language
- Willing to participate in this study
Key exclusion criteria (4 listed)
- Alteration of consciousness
- Experiencing complications, including neurogenic shock and autonomic dysreflexia
- Being pregnant
- Having fluid restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5E programParticipants 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 | Behavioural | 5E Program |
Primary outcome
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.
2 secondary outcomes
Signs and symptoms of deep venous thrombosis and pulmonary embolism
Time frame: The day before implementing the intervention and Day 1 - Day 7 after implementing intervention
Thigh and calf circumference
Time frame: The day before implementing the intervention and Day 1 - Day 7 after implementing intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5E program in people with Venous Thromboembolism and Spinal Cord Diseases, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wiphawadee Potisopha, Ph.D. (+660954291592, wiphpo@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of venous thromboembolism (time frame: The day before implementing the intervention and at 7 days after implementing intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.