Nursing-Led Deep Vein Thrombosis Prevention in Neurosurgery

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.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis (DVT)
• Intervention / Treatment: Behavioral: nurse-led program (early movement, leg-sleeve squeezes, and blood tests)

• Study Type: Interventional
• Enrollment (Actual): 1286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse-led prevention group; 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); 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
No Intervention: Standard post-neurosurgical care group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from surgery to first objectively confirmed DVT (days)	Time from surgery to first objectively confirmed DVT (days)	30 days
All-cause mortality within 30 days	All-cause mortality within 30 days	30 days

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Estimated): January 9, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Neurosurgery; Risk Prediction; Interdisciplinary Nursing; Multimodal Prevention
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: WestChinaH-HX-2025-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No