Nursing-Led Deep Vein Thrombosis Prevention in Neurosurgery

NCT07330661 | Completed DMC

• 1 other identifier: WestChinaH-HX-2025-010
• Study Type: interventional
• Target: 1,286
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

Neurosurgery; Interdisciplinary Nursing; Multimodal Prevention; Risk Prediction; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Incidence of objectively confirmed lower-extremity deep-vein thrombosis (DVT)

  diagnosed by blinded duplex ultrasound using standard non-compressibility or intraluminal thrombus criteria.

  30 days

Secondary Outcomes (2)

• Time from surgery to first objectively confirmed DVT (days)

  30 days

• All-cause mortality within 30 days

  30 days

Study Arms (2)

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

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.

Interventions

nurse-led program (early movement, leg-sleeve squeezes, and blood tests) BEHAVIORAL

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

Nurse-led prevention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: May 1, 2024
• Last Updated: January 12, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)