The Utility of Intra-Catheter Fibrinolytics in Draining Chronic Subdural Hematomas: A Randomized Controlled Trial Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Study Feasibility
研究概览
简要总结
To determine the utility of tissue plasminogen activator (tPA) in the clearance of chronic subdural hematomas (CSDH). Intra-catheter tPA will be administered during surgical procedure and allowed to break down blood clot to assist with removal/drainage during twist drill craniostomy procedure.
详细描述
A chronic subdural hematoma (CSDH) is a collection of blood overlying the brain that can be seen, usually in the elderly with even minimal head trauma. These are usually treated by removing the collection of blood. This can be done through a small drill hole in the skull or by larger holes (one or two) the size of a nickel. Sometimes a larger piece of skull is removed to be able to remove the CSDH. The standard practice at our center is to do these procedures under local anesthesia with a twist drill craniostomy (small drill hole through the skull). In some cases, all the CSDH can not be removed the first time, requiring a second procedure or a larger procedure. This study plans to use a type of medication that breaks down the solid blood clot, enabling more of it to drain. This medication (tpa) is already used in other surgeries and is safe to use in humans. Our preliminary experience and that of others suggests very low risk at the dosages being used. We hope that using this new drug will decrease the chance of the CSDH collecting again and reduce the overall length of your stay in the hospital and reduce the need for further surgery.
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)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 yrs or older)
- •Admitted to neurosurgery wing at the hospital
- •Symptomatic patients requiring surgical drainage by twist drill craniostomy
排除标准
- •Patients at increased risk of bleeding such as patients taking anticoagulation medication that required reversal at time of intervention، or those with coagulopathic disorder.
- •Patients on antiplatelets or anticoagulation medications (DOACs or warfarin) with appropriate holding period prior to drainage, those who are eventually minimized to a regular bleeding risk compared to the normal population, will be included in the study.
- •Patients with subdural empyema.
- •Redo twist drill craniostomy for residual cSDH within the same admission.
- •Drain accidentally removed during nursing care or patient transport before 24 hr interval scan.
- •Patients who are not expected to live more than three months.
研究组 & 干预措施
Intervention - tPA administered
This group will receive 2mL of intra-catheter tPA during twist drill craniostomy procedure
干预措施: Tissue Plasminogen Activator (Drug)
Placebo Control
This group will receive 2mL of intra-catheter saline solution during twist drill craniostomy procedure
干预措施: Placebo (Drug)
结局指标
主要结局
Study Feasibility
时间窗: 8 months
Patient recruitment rate, eligibility of patients, protocol adherence, unexpected events
次要结局
- Rate of adverse events(8 months)
- Volume of chronic subdural hematoma(8 months)
- Length of hospital stay(8 months)
- Reoperation rate(8 months)