Bedside Versus Operating Room Burr-Hole Drainage of Chronic Subdural Hematoma (DECIDE)
试验速览
- 阶段
- 不适用
- 入组人数
- 486
- 主要终点
- Recurrence rate of Chronic Subdural Hematoma
研究概览
简要总结
DECIDE (Bedside versus Operating Room Burr-Hole DrainagE of ChronIc SubDural HEmatoma)
CSDH is an abnormal collection of blood between the layers of the brain causing brain tissue compression leading to neurological complications. One of the most common risk factors contributing to CSDH is head trauma, which is usually in the form of a minor head injury. Older individuals are at increased risk of CSDH due to brain atrophy that occurs with advancing age as well as their tendency to fall and sustain minor head traumas. Chronic alcoholics are also at increased risk as alcoholism also leads to brain atrophy, increased risk of falls, and liver failure which results in increased bleeding risk. Also many drugs used today like anticoagulants, antithrombotics, and antiplatelets for certain health conditions are other common risk factors for CSDH.
The overall goal of this multi-centered trial in the USA and Canada is to assess the surgical management of chronic subdural hematoma (CSDH) and to demonstrate the effectiveness of bedside drainage and its safety as it bypasses the perioperative risk associated with anesthetic especially among the elderly.
Adult patients with a clear indication for CSDH drainage will be randomly assigned to one of two procedures. One group will receive the twist drill procedure which can be performed at the bedside. The second group will undergo the burr-hole drainage procedure in the operating room usually under general anesthetic. Typically, the twist drill procedure can occur sooner as the operating room and Anesthetist are not required. Reoccurrence of the CSDH will be assessed over a period of 6 months following drainage. Timing of procedure, risk of infection, adverse side effects and neurological functioning will also be measured.
Over a 3 year study period, 486 eligible patients (243 patients per arm) will be enrolled. Patients > 18 years with confirmed diagnosis of symptomatic CSDH will be provided one of the two procedures and will be followed for study outcomes at 1, 3 and 6 months following the procedure.
Primary analysis will be to compare the surgical procedures, assessing the recurrence rate of CSDH within 6 months of initial CSDH drainage.
The ultimate goal of this study is to standardize bedside drainage as the treatment of choice for CSDH management.
This trial is important in the ongoing search for more efficient and safe intervention strategies.
详细描述
DECIDE (Bedside versus Operating Room Burr-Hole DrainagE of ChronIc SubDural HEmatoma)
Background and Significance: Chronic subdural hematoma (CSDH) is an abnormal collection of liquefied blood products between the dura and arachnoid membranes of the brain that may cause brain tissue compression and subsequent neurological sequelae. One of the most common risk factors contributing to CSDH is head trauma, which is usually in the form of a minor head injury. Older individuals are at increased risk of CSDH due to brain atrophy that occurs with advancing age as well as their tendency to fall and sustain minor head traumas. Chronic alcoholics are also at increased risk as alcoholism leads to globalized brain atrophy, increased risk of falls, and hepatogenic coagulopathy. Coagulopathies including the use of anticoagulants, antithrombotics, and antiplatelets for certain health conditions are other common risk factors for CSDH.
Study Aims: The primary aim of our study is to conduct a high-quality randomized trial to compare the safety and effectiveness of the bedside and operating room burr-hole drainage of CSDH. The main objective of this study is to demonstrate the effectiveness of bedside drainage and its safety as it bypasses the perioperative risk associated with anesthetic especially among the elderly.
The ultimate goal of this study is to standardize bedside drainage as the treatment of choice for CSDH management.
Primary Objective: To assess the efficacy of bedside drainage compared to operating room burr-hole evacuation for CSDH management by examining the hypothesis that bedside is associated with lower recurrence rate.
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
- None
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 aged >/= 18 years
- •Presenting with symptomatic Chronic Subdural Hematoma confirmed on diagnostic imaging
- •Able to provide informed consent or have a legal representatives available if unable to do so
排除标准
- •Patients with acute or subacute subdural hematoma
- •Patients with incidental or asymptomatic findings on CT; skull base, posterior fossa, or in the inter-hemispheric fissure Chronic Subdural Hematoma
- •Patients with recurrent hematoma within 6 months of initial drainage
- •Patients with Chronic Subdural Hematoma from previous intracranial surgery for different pathology Patients with subdural hygroma and non-hairline skull fracture over the Chronic Subdural Hematoma
- •Patients with significant cognitive impairment or severe co-morbidity preventing improvement or follow-up
- •Patients with hemorrhagic tendency that cannot be normalized
- •Patients on anticoagulants, antithrombotics, or antiplatelets unless reversed or cleared - Patients who are unlikely to be available for a 6-month follow-up period
研究组 & 干预措施
CSDH Bedside twist drill technique
For patients randomized to bedside drainage of Chronic Subdural Hematoma, the twist-drill procedure will be conducted at the patient's bedside using local anesthetic.
干预措施: CSDH - Bedside twist drill technique (Procedure)
CSDH Operating Room Burr-hole technique
For patients randomized to burr-hole drainage, the procedure will be performed in the operating room under local or general anesthesia based on the surgeon's and anesthesiologist's judgement of the clinical stability of the patient.
干预措施: CSDH - Operating Room Burr-hole technique (Procedure)
结局指标
主要结局
Recurrence rate of Chronic Subdural Hematoma
时间窗: 6 months
次要结局
- surgical site infection rate(6 Months)
- tension pneumocephalus(6 Months)
- morbidity(6 Months)
- Postoperative neurological and functional status - MGS(6 Months)
- Postoperative neurological and functional status - GOS(6 Months)
- Postoperative neurological and functional status - MRS(6 Months)
- safety - misplacement of postoperative subdural drain(6 Months)
- new intracranial hemorrhage rate(6 Months)
- mortality(6 Months)
研究者
Saleh Almenawer
Neurosurgeon, Division of Neurosurgery, Principal Investigator
Hamilton Health Sciences Corporation