Nursing-Led Deep Vein Thrombosis Prevention in Neurosurgery

Sichuan University

Status: Completed

Conditions: Deep Vein Thrombosis (DVT)

Treatments: Behavioral: nurse-led program (early movement, leg-sleeve squeezes, and blood tests)

Study type: Interventional

Funder types: Other

Identifiers

NCT07330661

WestChinaH-HX-2025-010

Details and patient eligibility

About

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.

Enrollment: 1,286 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,286 participants in 2 patient groups

Nurse-led prevention group

Experimental group

Description:

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

Treatment:

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

Standard post-neurosurgical care group

No Intervention group

Description:

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.