Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery: a Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 582
- 试验地点
- 7
- 主要终点
- modified Rankin Scale (mRS) 0-2
研究概览
简要总结
To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3~6 months after DC.
详细描述
Objective:
To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3~6 months after DC.
Design:
This study is a multi-center, prospective, randomized controlled, open-label trial.
Interventions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study was open-label, endpoint-blinded, i.e. only the patients themselves and the treating physicians knew the randomization assignment results, baseline was evaluated by investigators who did not know the actual patient assignment, and primary endpoint visits were conducted by trained third parties who did not know what treatment the patients received.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Decompressive craniectomy due to craniocerebral trauma, cerebral ischemia and cerebral hemorrhage.
- •Age 18 - 80 years.
- •The first time for cranial repair.
- •unilateral skull defect.
- •Compliant with recommended decompressive bone flap surgery and autogenous decompressive bone flap after bone flap collection
- •signed the informed consent.
排除标准
- •Poor healing of skin flap (active infection, non-healing, necrosis, sinus, thin or poor blood supply, etc.).
- •Fracture of bone flap ≥2 pieces, partial open fracture
- •Intracranial infection before operation.
- •Severe bone metabolic diseases.
- •Long-term use of immunosuppressants.
- •Pregnant or lactating women.
- •Coagulation disorders.
- •Severe cardiopulmonary insufficiency.
- •It is estimated that the CP process cannot be completed within 6 weeks after the bone plate decompression surgery.
- •Skull defect size less than 25cm².
- •Life expectancy less than 1 year.
- •mRS greater than 1 before primary disease.
- •Diabetic patients.
- •Patients who are unable to cooperate with follow-up assessment (e.g. mental illness).
结局指标
主要结局
modified Rankin Scale (mRS) 0-2
时间窗: at 180 (± 7) days
The proportion of patients with a modified Rankin Scale (mRS) score of ≤ 2
次要结局
- mRS≤2 and mRS ≤3(90 (±7) days after CP)
- mRS ≤3(180 (±7) days after CP)
- Mini-Mental State Examination (MMSE) score(90 days (±7 days) and 180 days (±7 days) after CP surgery)
- Glasgow Outcome Score (GOS)(90 days (±7 days) and 180 days (±7 days) after CP surgery)
- hydrocephalus or Cerebrospinal fluid shunt surgery rate(90 days (±7 days) and 180 days (±7 days) after CP surgery)
- Total medical expenses (excluding materials)(At the time of discharge from CP, 90 (±7) days after CP-CP and 180 (±7) days after CP-CP at discharge)
- Complications related medical expenses(At the time of discharge from CP, 90 (±7) days after CP-CP and 180 (±7) days after CP-CP at discharge)
- Incidence of infection, poor healing, and subcutaneous effusion(90 days (±7 days) and 180 days (±7 days) after CP surgery)
- The incidence rate of intracranial hemorrhage(90 days (±7 days) and 180 days (±7 days) after CP surgery)
- incidence of epilepsy(90 days (±7 days) and 180 days (±7 days) after CP surgery)
- incidence of reoperation(90 days (±7 days) and 180 days (±7 days) after CP surgery)
研究者
Kaya Xu
Principal Investigator
The Affiliated Hospital Of Guizhou Medical University