Deep Vein Thrombosis (DVT)
Conditions
Keywords
Neurosurgery, Interdisciplinary Nursing, Multimodal Prevention, Risk Prediction, Randomized Controlled Trial
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.
Interventions
BEHAVIORALnurse-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
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of objectively confirmed lower-extremity deep-vein thrombosis (DVT) | 30 days | diagnosed by blinded duplex ultrasound using standard non-compressibility or intraluminal thrombus criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from surgery to first objectively confirmed DVT (days) | 30 days | Time from surgery to first objectively confirmed DVT (days) |
| All-cause mortality within 30 days | 30 days | All-cause mortality within 30 days |
Countries
China
Outcome results
None listed