The Finnish Study of Intraoperative Irrigation Versus Drain Alone After Evacuation of Chronic Subdural Hematoma (FINISH): a Study Protocol for a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 587
- 试验地点
- 1
- 主要终点
- Rate of re-operations of ipsilateral chronic subdural hematoma
研究概览
简要总结
FINISH-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (CSDH) with intraoperative irrigation (IR) and evacuation of CSDH without irrigation (N-IR).
详细描述
FINISH-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (CSDH) with intraoperative irrigation (IR) and evacuation of CSDH without irrigation (N-IR). In both groups, a passive subdural drain is used for 48 hours as a standard of treatment. The study will be conducted in all five neurosurgical departments in Finland. To determine whether operation without irrigation results in non-inferior outcome to operation with irrigation, we will randomize 426 patients into two groups and follow them up for 6 months using recurrence rates as the primary outcome. Secondary outcomes in our study include mortality, neurological outcome and complications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Due to the nature of the treatment, it is not possible to blind the surgeon and OR staff from the treatment allocation. Measures to minimize bias include:
- The patient will not be informed of treatment allocation
- Treatment allocation will not be documented in medical records i.e. all the personnel participating in patient care after operation will be blinded to allocation
- The study group members collecting postoperative data and performing the statistical analyses will be blinded to treatment arm until the analyses are finished.
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
- •Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation
- •o Predominantly hypodense or isodense on imaging (CT/MRI).
- •Clinical symptoms correlating with the CSDH
- •Patients with bilaterally operated CSDHs will be treated with the same protocol on both sides and analyzed as a single study participant
排除标准
- •CSDH requiring surgical treatment other that burr-hole evacuation (e.g. craniotomy)
- •CSDH in a patient who has a cerebrospinal fluid shunt
- •Patients who have undergone any intracranial surgery before
- •Comatose patients (GCS 8 or lower) with absent motor responses to painful stimuli; decerebrate or decorticate posturing
- •Patient's postoperative cooperation is suspected to be insufficient for drain usage, i.e. disoriented or semiconscious patient
- •Patient has a hematogenic malignancy that has obtained active treatment within the previous five years
- •Patient has a central nervous system tumor or malignancy
- •Patient has acute infection with fever and requires antibiotic treatment at the moment
- •Patient has a high risk of life-threatening thrombosis (e.g. recent coronary stent, recent pulmonary embolism, low cardiac valve replacement) and discontinuation of antithrombotic medication is not recommended
结局指标
主要结局
Rate of re-operations of ipsilateral chronic subdural hematoma
时间窗: From operation up to 6 months after postoperatively
Rate of reoperations between groups
次要结局
- Rate of complications and adverse events within 6 months(within 6 months after operation)
- Change in the volume of CSDH in the CT or MRI image between baseline and 2 months post-operatively(Immediate preoperative and 2 months postoperatively)
- Change of Modified Rankin Scale (MRS) from baseline to 6 months after operation(At baseline, and at 2 and 6 months after operation)
- Rate of mortality between intervention groups(From operation up to 6 months postoperatively)
- Duration of the operation between groups(Intraoperative measure)
- Hospital length of stay between groups(From operation up to six months)
研究者
Kimmo Lonnrot
Principal Investigator
Helsinki University Central Hospital