Deep Vein Thrombosis (DVT)NCT07330661
Nursing-Led Deep Vein Thrombosis Prevention in Neurosurgery
A study testing nurse-led program (early movement, leg-sleeve squeezes, and blood tests) in people with Deep Vein Thrombosis (DVT), run by West China Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to see if a nurse-led program (early movement, leg-sleeve squeezes, and blood tests) can prevent dangerous leg blood clots in adults who have just had brain or spine surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis (DVT)
- What is being tested?
- nurse-led program (early movement, leg-sleeve squeezes, and blood tests)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,286 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 May 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
- Age ≥ 18 years
- Any elective or emergency craniotomy, spinal, or other neurosurgical procedure
- Expected post-operative hospital stay ≥ 3 days
- Patient or legally authorized representative willing and able to give written informed consent
Who cannot join
- Pre-operative ultrasound or imaging proven DVT or pulmonary embolism
- Known hereditary bleeding disorder (e.g., hemophilia) or platelet count < 50 × 10⁹/L
- Chronic therapeutic anticoagulation (warfarin, DOAC, heparin) that cannot be safely stopped, or need for full-dose post-op anticoagulation
- Severe liver disease (Child-Pugh class C) or eGFR < 30 mL/min/1.73 m²
- Life-limiting co-morbidity with expected survival < 30 days
- Pregnancy or breastfeeding
- Current participation in another interventional VTE trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurointerdisciplinary Nursing Prevention Strategies for Deep Vein Thrombosis (DVT) After Neurosurgical Procedures: A Multicenter Randomized Controlled Trial and Nomogram Development
The goal of this clinical trial is to see if a nurse-led program (early movement, leg-sleeve squeezes, and blood tests) can prevent dangerous leg blood clots in adults who have just had brain or spine surgery.
Main questions it aims to answer:
- Does the program lower the number of clots within 30 days after surgery?
- Is the program safer and more accurate than the usual clot-risk score nurses already use?
Researchers will compare patients who receive the nurse-led program with patients who receive standard hospital care.
Participants will:
- Be randomly assigned to one of the two groups.
- Have regular leg ultrasounds to check for clots.
- Wear a small activity tracker if they are in the nurse-led group.
- Conditions
- Deep Vein Thrombosis (DVT)
- Being tested
- nurse-led program (early movement, leg-sleeve squeezes, and blood tests)
- Keywords
- Neurosurgery, Interdisciplinary Nursing, Multimodal Prevention, Risk Prediction, Randomized Controlled Trial
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse-led program (early movement, leg-sleeve squeezes, and blood tests)Behavioural
Graded early-movement plan starting within 24 h of surgery
- Unconscious patients: passive leg exercises 10-15 min, 3× daily
- Conscious patients: assisted leg, sitting and walking sessions escalated daily (target ≥ 40 min total activity, logged automatically by a wrist-band activity tracker) Intermittent pneumatic compression (IPC)
- 2 h/session, 2× daily, 30-45 mmHg while in bed, continued until independent walking D-dimer blood checks on post-op days 1, 3, 7 and 14; any rise ≥ 20 % or level > 2 mg/L triggers an extra leg ultrasound Continuous safety watch (heart rate, blood pressure, intracranial pressure if monitored); IPC or movement is paused if pressure > 20 mmHg or vital signs become unstable
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led prevention group | Experimental | In addition to routine post-operative care, participants assigned to the nurse-led prevention arm receive:
* Graded early-movement plan starting within 24 h of surgery
* Unconscious patients: passive leg exercises 10-15 min, 3× daily
* Conscious patients: assisted leg, sitting and walking sessions escalated daily (target ≥ 40 min total activity, logged automatically by a wrist-band activity tracker)
* Intermittent pneumatic compression (IPC)
* 2 h/session, 2× daily, 30-45 mmHg while in bed, continued until independent walking
* D-dimer blood checks on post-op days 1, 3, 7 and 14; any rise ≥ 20 % or level > 2 mg/L triggers an extra leg ultrasound
* Continuous safety watch (heart rate, blood pressure, intracranial pressure if monitored); IPC or movement is paused if pressure > 20 mmHg or vital signs become unstable
All steps are recorded in the electronic nursing chart and coordinated by a neurosurgery-rehabilitation-data Receives: Behavioral: nurse-led program (early movement, leg-sleeve squeezes, and blood tests) |
| Standard post-neurosurgical care group | No intervention | Participants in the control arm receive the hospital's standard post-neurosurgical care, which follows current Chinese and U.S. VTE-guidelines and includes: * Routine hydration and general health-education advice * Graduated compression stockings (class II, knee-high) worn 8-12 h each day until the patient is walking independently * Gentle passive leg movements (about 10 min, 1-2 times daily) when nursing staff judge it safe * Low-molecular-weight heparin (40 mg enoxaparin subcutaneous once daily) only for patients judged to be at low bleeding risk (Caprini 4-7) and with no intracranial hemorrhage No systematic Caprini re-assessments, no scheduled early-mobilization protocol, no IPC machines, no D-dimer surveillance, and no activity trackers are used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of objectively confirmed lower-extremity deep-vein thrombosis (DVT)
diagnosed by blinded duplex ultrasound using standard non-compressibility or intraluminal thrombus criteria.
Measured: 30 days
Secondary outcomes (2)
Time from surgery to first objectively confirmed DVT (days)
Time from surgery to first objectively confirmed DVT (days)
Measured: 30 days
All-cause mortality within 30 days
All-cause mortality within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jan 2021
- Primary completion30 Dec 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis (DVT)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Lan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330661
- Sponsor's protocol ID
- WestChinaH-HX-2025-010
- Status last verified
- Dec 2024
- First submitted
- 28 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurointerdisciplinary Nursing Prevention Strategies for Deep Vein Thrombosis (DVT) After Neurosurgical Procedures: A Multicenter Randomized Controlled Trial and Nomogram Development
- ClinicalTrials.gov ID
- NCT07330661
- Acronym / sponsor ID
- WestChinaH-HX-2025-010
- Conditions
- Deep Vein Thrombosis (DVT)
- Keywords
- Neurosurgery, Interdisciplinary Nursing, Multimodal Prevention, Risk Prediction, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,286 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 9 Jan 2026 (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 clinical trial is to see if a nurse-led program (early movement, leg-sleeve squeezes, and blood tests) can prevent dangerous leg blood clots in adults who have just had brain or spine surgery.
Main questions it aims to answer:
- Does the program lower the number of clots within 30 days after surgery?
- Is the program safer and more accurate than the usual clot-risk score nurses already use?
Researchers will compare patients who receive the nurse-led program with patients who receive standard hospital care.
Participants will:
- Be randomly assigned to one of the two groups.
- Have regular leg ultrasounds to check for clots.
- Wear a small activity tracker if they are in the nurse-led group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led prevention group | Experimental | Behavioral: nurse-led program (early movement, leg-sleeve squeezes, and blood tests)In addition to routine post-operative care, participants assigned to the nurse-led prevention arm receive: * Graded early-movement plan starting within 24 h of surgery * Unconscious patients: passive leg exercises 10-15 min, 3× daily * Conscious patients: assisted leg, sitting and walking sessions escalated daily (target ≥ 40 min total activity, logged automatically by a wrist-band activity tracker) * Intermittent pneumatic compression (IPC) * 2 h/session, 2× daily, 30-45 mmHg while in bed, continued until independent walking * D-dimer blood checks on post-op days 1, 3, 7 and 14; any rise ≥ 20 % or level > 2 mg/L triggers an extra leg ultrasound * Continuous safety watch (heart rate, blood pressure, intracranial pressure if monitored); IPC or movement is paused if pressure > 20 mmHg or vital signs become unstable All steps are recorded in the electronic nursing chart and coordinated by a neurosurgery-rehabilitation-data |
| Standard post-neurosurgical care group | No intervention | –Participants in the control arm receive the hospital's standard post-neurosurgical care, which follows current Chinese and U.S. VTE-guidelines and includes: * Routine hydration and general health-education advice * Graduated compression stockings (class II, knee-high) worn 8-12 h each day until the patient is walking independently * Gentle passive leg movements (about 10 min, 1-2 times daily) when nursing staff judge it safe * Low-molecular-weight heparin (40 mg enoxaparin subcutaneous once daily) only for patients judged to be at low bleeding risk (Caprini 4-7) and with no intracranial hemorrhage No systematic Caprini re-assessments, no scheduled early-mobilization protocol, no IPC machines, no D-dimer surveillance, and no activity trackers are used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Any elective or emergency craniotomy, spinal, or other neurosurgical procedure
- Expected post-operative hospital stay ≥ 3 days
- Patient or legally authorized representative willing and able to give written informed consent
Key exclusion criteria (7 listed)
- Pre-operative ultrasound or imaging proven DVT or pulmonary embolism
- Known hereditary bleeding disorder (e.g., hemophilia) or platelet count < 50 × 10⁹/L
- Chronic therapeutic anticoagulation (warfarin, DOAC, heparin) that cannot be safely stopped, or need for full-dose post-op anticoagulation
- Severe liver disease (Child-Pugh class C) or eGFR < 30 mL/min/1.73 m²
- Life-limiting co-morbidity with expected survival < 30 days
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 |
|---|---|---|
| nurse-led program (early movement, leg-sleeve squeezes, and blood tests)Graded early-movement plan starting within 24 h of surgery * Unconscious patients: passive leg exercises 10-15 min, 3× daily * Conscious patients: assisted leg, sitting and walking sessions escalated daily (target ≥ 40 min total activity, logged automatically by a wrist-band activity tracker) Intermittent pneumatic compression (IPC) * 2 h/session, 2× daily, 30-45 mmHg while in bed, continued until independent walking D-dimer blood checks on post-op days 1, 3, 7 and 14; any rise ≥ 20 % or level > 2 mg/L triggers an extra leg ultrasound Continuous safety watch (heart rate, blood pressure, intracranial pressure if monitored); IPC or movement is paused if pressure > 20 mmHg or vital signs become unstable | Behavioural | Nurse-led prevention group |
Primary outcome
Incidence of objectively confirmed lower-extremity deep-vein thrombosis (DVT)
Time frame: 30 days
diagnosed by blinded duplex ultrasound using standard non-compressibility or intraluminal thrombus criteria.
2 secondary outcomes
Time from surgery to first objectively confirmed DVT (days)
Time frame: 30 days
All-cause mortality within 30 days
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-led program (early movement, leg-sleeve squeezes, and blood tests) in people with Deep Vein Thrombosis (DVT), run by West China Hospital at 1 site in China.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 12 Jan 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of objectively confirmed lower-extremity deep-vein thrombosis (DVT) (time frame: 30 days). 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 12 Jan 2026.