Neurointerdisciplinary Nursing Prevention Strategies for Deep Vein Thrombosis (DVT) After Neurosurgical Procedures: A Multicenter Randomized Controlled Trial and Nomogram Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,286
- 试验地点
- 1
- 主要终点
- Incidence of objectively confirmed lower-extremity deep-vein thrombosis (DVT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: nurse-led program (early movement, leg-sleeve squeezes, and blood tests) (Behavioral)
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.
结局指标
主要结局
Incidence of objectively confirmed lower-extremity deep-vein thrombosis (DVT)
时间窗: 30 days
diagnosed by blinded duplex ultrasound using standard non-compressibility or intraluminal thrombus criteria.
次要结局
- Time from surgery to first objectively confirmed DVT (days)(30 days)
- All-cause mortality within 30 days(30 days)
研究者
Zhigang Lan
Professor
West China Hospital