Randomized Trial Comparing Adjuvant Tranexamic Acid Versus Surgery Alone For Chronic Subdural Hematoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 274
- 试验地点
- 2
- 主要终点
- Recurrence of symptomatic chronic subdural hematoma requiring repeat surgery within 90 days
研究概览
简要总结
This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission. Patients eligible for inclusion will be randomized to receive treatment with Tranexamic acid (TXA) as an adjunct to surgery or surgery alone. Surgical evacuation will be performed using a single or double burr hole and 24 hours postoperative drainage. The primary endpoint will be recurrent hematoma requiring repeat surgery within 90 days. Secondary outcomes will be modified Rankin Scale at 90 days, EQ-5D-5L, complications and adverse events, and 90-day mortality.
详细描述
This study is a prospective single-center open-label randomized controlled trial (RCT) investigating whether the administration of tranexamic acid (TXA) as an adjuvant to surgery reduces the recurrence rate of chronic subdural hematoma (CSDH) compared to surgery alone.
CSDH is a frequent neurosurgical condition, especially among elderly patients, and carries a substantial risk of recurrence after surgical evacuation. Despite standardized procedures such as burr hole drainage and postoperative irrigation with 24-hour drainage, reoperation rates remain high (5-20%). There is currently a need for adjunctive therapies to reduce recurrence and improve clinical outcomes.
Tranexamic acid is a well-established antifibrinolytic agent that inhibits plasminogen activation and stabilizes blood clots. While observational studies and limited randomized trials have suggested a potential benefit of TXA in CSDH patients, conclusive evidence remains lacking.
This trial (RATATA) randomly assigns eligible adult patients with symptomatic CSDH confirmed via CT or MRI to receive either standard surgical treatment or surgery plus adjuvant TXA. Participants in the intervention arm receive a total of 2g IV TXA (1g <12h pre-op and 1g 12h post-op) and continue with oral TXA 500 mg twice daily for four weeks.
The primary endpoint is recurrence of the ipsilateral CSDH requiring repeat surgery within 90 days of the index operation. Recurrence is defined by both clinical deterioration and radiologically confirmed hematoma. Secondary endpoints include functional outcomes measured by the Modified Rankin Scale (mRS), health-related quality of life assessed using EQ-5D-5L, complication and adverse event rates, and 90-days mortality.
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
- •Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness.
- •Adult patient ≥18 years
- •Scheduled for single or double burr hole for evacuation.
- •No contraindication for TXA
排除标准
- •Mechanical heart valve
- •Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment
- •Intracranial surgery within last 6 months
- •Pregnancy and woman<40 years
- •Participation in any other clinical trial
- •Life expectancy of less than one year.
- •A score on the modified Rankin scale, designed to assess functional independence, of 4 or 5 (scores range from 0 [no symptoms] to 6 [death]) before the hematoma occurred.
- •Unfit for participations for any other reason as evaluated by the including physician.
- •History of severe impairment of renal function (eGFR <30ml/min or serum creatinine >150μmol/L)
- •Known hypersensitivity or allergy to TXA
- •Inability to obtain informed consent from the patient or legal representative
研究组 & 干预措施
Standard surgical treatment with adjunctive treatment with tranexamic acid
Surgical evacuation with tranexamic acid. Preoperative administration of 1g IV with additional 1g administrated postoperatively. Followed by 500mg two times a day for a total of 28 days.
干预措施: Tranexamic Acid (Cyklokapron) (Drug)
结局指标
主要结局
Recurrence of symptomatic chronic subdural hematoma requiring repeat surgery within 90 days
时间窗: 90 days
Number of patients with a radiological and clinical significant recurrent hematoma withing 90 days
次要结局
- Health-related Quality Of Life(90 days)
- Headache(90 days)
- Complications and adverse events(90 days)
- Mortality(90 days)
- Functional outcome(90 days)