Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: An Observer-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Chronic subdural hematoma volume change
研究概览
简要总结
Chronic subdural hematoma (CSDH), a common disease after minor head trauma, is characterized by blood collection in the subdural space, which can result in severe neurological impairment. The current standard of care is the surgical evacuation of CSDH. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity, mortality and recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach to treat CSDH is desirable. Tranexamic acid (TXA), an antifibrinolytic drug, has been shown to decrease hematoma volume in a small cohort of CSDH patients. The present study is designed to test the hypothesis that TXA can reduce the volume of CSDH. Volume measurements of residual CSDH after burr-hole surgery will be performed to quantify treatment success. The trial is designed as a double-blinded randomized controlled trial, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive placebo. The primary endpoint is defined as volume change in milliliter after 4-8 weeks of treatment. Secondary endpoints are hematoma volume at 8-12 weeks, patient safety, the number of patients with resolution of the CSDH after 4-8 and 8-12 weeks of study participation, the neurological outcome, the rate of reoperation, the time to reoperation, drug safety and compatibility, and participant quality of life (QOL).
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
- Double (Participant, Investigator)
盲法说明
Double-blind
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
- •Diagnosis of chronic subdural hematoma (CSDH)
- •Written informed consent (patient, power of attorney or substitute decision maker)
- •Competence to take study medication properly and regularly or access to caregiver that is able to comply with accurate study medication administration
排除标准
- •Hypersensitivity to TXA or any of the ingredients
- •Pregnancy
- •Irregular menstrual bleeding with unidentified cause
- •Acquired colour vision disturbances
- •Acute and chronic renal insufficiency indicated by GFR ≤ 30 mL/min
- •Hematuria, caused by diseases of renal parenchyma
- •Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
- •History of angioplasty with cardiac stent placement, or cardiac (including mechanical) valve placement
- •Active history of stroke (hemorrhagic and ischemic), or subarachnoid hemorrhage, within the past 6 months
- •Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days
- •History of malignant brain tumors (glioma, metastasis and others) or seizures within the 6 months
- •Contraindication to stopping full therapeutic doses of non-ASA antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
- •Inability of oral drug intake or missing support to guarantee oral drug intake
- •SDH as caused by intracranial hypotension resulting from CSF shunt placement
研究组 & 干预措施
Tranexamic Acid Arm
Participants in the experimental arm will receive tranexamic acid (TXA) during surgery for CSDH evacuation with a single 1000mg intraoperative intravenous (IV) dose. Participants with a body weight 60-100kg will also receive a post-operative dose regimen of 500 mg TXA orally, 3 times a day (TID).
Weight deviations from this body weight range will be considered with a dose adjustment of 1000mg TXA two times a day (BID) for a body weight >100 kg, and 500 mg TXA BID for body weight <60kg.
干预措施: Tranexamic Acid 500 MG (Drug)
Placebo Control Arm
Participants in the control arm will placebo according to the same administration regimen.
干预措施: Placebo (Drug)
结局指标
主要结局
Chronic subdural hematoma volume change
时间窗: At 4-8 weeks
Change in hematoma volume in mL according to CT-scan-based volume measurements comparing hematoma on CT scan performed at 4-8 weeks to hematoma on immediate post-operative CT scan.
次要结局
- Chronic subdural hematoma volume change(At 12 weeks)
- Rate of adverse events (AEs)(At 4, 8, and 12 weeks)
- 36-Item Short Form Survey (SF-36)(At 4, 8, 12 weeks)
- National Institutes of Health Stroke Scale (NIHSS)(At 4, 8, and 12 weeks)
- Modified Rankin Scale (mRS)(At 4, 8, and 12 weeks)
- Markwalder's grading scale (MGS)(At 4, 8, and 12 weeks)
- Rate of re-operation(At 4, 8, and 12 weeks)
- Time to reoperation(At 4, 8, and 12 weeks)