Nursing-Led Deep Vein Thrombosis Prevention in Neurosurgery

NCT ID: NCT07330661

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-05-01

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhigang Lan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

WestChinaH-HX-2025-010

Identifier Type: -

Identifier Source: org_study_id