Tranexamic Acid Therapy For The Treatment of Subdural Hematomas
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Rate of resolution measured as the cSDH volume or diameter
研究概览
简要总结
This Phase II randomized, placebo-controlled, double-blinded trial is the first step in our endeavor to improve the clinical outcomes of patients with chronic subdural hematomas (cSDH). Patients who are deemed to not need surgery for their cSDH will be randomly assigned to either the treatment group or the placebo group. Both groups will take a 650mg tablet once daily for 21 weeks and follow the standard of care monitoring for cSDH which is neurological testing and imaging at 6 weeks, 12 weeks, and 21 weeks. With this study, we hope to establish the safety and efficacy of using TXA PO to resolve cSDH without the need for surgical intervention.
详细描述
Patients must first be evaluated by a neurosurgeon and concluded to be managed conservatively, without a surgical procedure. Then patients may be enrolled into the study if they meet the specific inclusion and exclusion criteria mentioned above.
If the patient signs the informed consent and is enrolled into the study, the treating physician will inform the study team. The patient will be randomized into either treatment or placebo group per the above algorithm. The study will be double-blind, and only the statistician will know the patient groupings.
In the event that unblinding is needed, the statistician will inform the treating physician of the patient's study group.
Tranexamic acid (TXA), the study agent, or matching placebo will be prescribed as a 650mg tablet to be taken once daily for 21 weeks. The drug will be provided as an oral tablet from the pharmacy. The placebo will be a similar tablet. Once prescribed patients will follow the standard of care for conservative management of chronic subdural hematoma.
Baseline evaluation
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
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CT scan demonstrating existence of a subdural hematoma, unilateral or bilateral, containing a chronic component
- •Neurosurgeon evaluation deemed patient to not need surgery
- •Diagnosis within the last 14 days
- •Signed informed consent
- •Competence to take study medications properly and regularly or access to care giver that is able to comply with accurate study medication administration
排除标准
- •Planned surgery, burr-hole craniostomy or mini-craniotomy for their chronic subdural hematoma based on one or more of the following symptoms: medically intractable headache, midline shift >5mm, SDH thickness >10mm, increased ICP, imminent death within 24 hours
- •Structural causes for subdural hemorrhage (arachnoid cysts, cortical vascular malformations)
- •Recent ischemic stroke
- •Other concomitant intracranial pathology (intracranial malignancy)
- •Active malignancy
- •Need for chronic therapeutic anticoagulation (i.e. atrial fibrillation)
- •Acute subdural hematoma with no chronic component
- •Active treatment for deep vein thrombosis, pulmonary embolism or cerebral thrombosis (secondary prophylaxis is not considered to be active treatment)
- •Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency
- •History of thrombosis or thromboembolism, including retinal vein or artery occlusions
- •An intrinsic risk of thrombosis or thromboembolism
- •Aneurysmal subarachnoid hemorrhage
- •Concurrent use of Factor IX complex concentrate or anti-inhibitor coagulant concentrates
- •Concurrent use of all-trans retinoic acid
- •Active intravascular clotting or disseminated intravascular coagulation
- •Need for tissue plasminogen activators
- •Known hypersenstivity to TXA or any of the ingredients
- •Acute and chronic renal insufficiency indicated by glomerular filtration rate (GFR) < 60 mL/min or creatinine > 2.8 mg/dL
- •Hematuria, caused by diseases of renal parenchyma
- •Pregnancy or breastfeeding*
- •Concomitant hormonal contraception*
- •History of convulsions
- •History of angioplasty with cardiac stent placement or mechanical heart valve
- •Any concern from the attending physician
研究组 & 干预措施
PO 650mg TXA tablet
650mg tablets of TXA will be prescribed to be taken orally, once daily for 21 weeks.
干预措施: Tranexamic Acid 650 MG (Drug)
PO 650mg placebo tablet
650mg placebo tablet will be prescribed to be taken orally, once daily for 21 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of resolution measured as the cSDH volume or diameter
时间窗: 6 weeks, 12 weeks, 21 weeks
次要结局
- cSDH volume (measured as volume or diameter on follow-up CT scan of the head)(6 weeks, 12 weeks, 21 weeks)
- Proportion of patients needing surgery(12 weeks, 12 weeks, 21 weeks)
- Hematoma recurrence Hematoma recurrence(12 weeks, 12 weeks, 21 weeks)
- Neurological outcome assessed by NIHSS(6 weeks, 12 weeks, 21 weeks)
- Functional outcome assessed by mRS(6 weeks, 12 weeks, 21 weeks)
- Functional outcome assessed by GOSE(6 weeks, 12 weeks, 21 weeks)
- Occurrence of adverse events(6 weeks, 12 weeks, 21 weeks)
研究者
Omar Tanweer
Director of Cerebrovascular and Endovascular Neurosurgery
Baylor College of Medicine