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Completed

NCT Number: NCT07330661

Nursing-Led Deep Vein Thrombosis Prevention in Neurosurgery

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.

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Key information

Conditions

Deep Vein Thrombosis (DVT) Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time from surgery to first objectively confirmed DVT (days)

    Time frame: 30 days

    Time from surgery to first objectively confirmed DVT (days)

  2. All-cause mortality within 30 days

    Time frame: 30 days

    All-cause mortality within 30 days

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Neurointerdisciplinary Nursing Prevention Strategies for Deep Vein Thrombosis (DVT) After Neurosurgical Procedures: A Multicenter Randomized Controlled Trial and Nomogram Development

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 9, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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