An Investigator-initiated and Conducted Multicentre, Prospective, Randomised, Double-blinded Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Chinese Herbal Medicine in Patients With Acute Intracerebral Haemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,504
- 试验地点
- 1
- 主要终点
- Utility-weighted modified Rankin scale scores
研究概览
简要总结
TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine FYTF-919 in reducing haematoma and bleeding after acute ICH from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study aims to determine the effectiveness and safety of TCM in a larger sample of patients with moderate-severe ICH and provide evidence for TCM clinical guidelines on ICH management. The presumed mechanism of action is in promoting the reabsorption of the haematoma and perihematomal oedema in ICH.
详细描述
A multicentre, prospective, randomised, double-blind, placebo-controlled trial to be conducted through hospital network of investigators in China. A total of 1504 patients with ICH will be recruited from approximately 20-30 hospitals. Randomised is via a central internet-based system according to block random grouping method stratified by site, neurological severity NIHSS <15 vs ≥15), and haematoma location (basal ganglia + lobe vs thalamus + cerebellum + brain stem + ventricle) to ensure balance in key prognostic factors. Endpoint assessment will be blinded to treatment allocation. The primary aim of this study is to determine the effectiveness and safety of a Chinese herbal medicine FYTF-919 as compared to placebo on functional recovery according to Utility-weighted modified Rankin scale (UW-mRS) at 90 days after acute ICH. Secondary aims include examining whether the Chinese herbal medicine FYTF-919 leads to positive treatment effect on: 1) Utility-weighted mRS scores at 180 days; 2)Ordinal analysis of 7 levels of mRS at 28 days, 90 days and 180 days; 3) Poor prognosis, defined as mRS 4-6 points at 28 days, 90 days and 180 days; 4) NIHSS score at 7 days and 28 days; 5) Mortality rate at 28 days, 90 days and 180 days; 6) Discharge rate at 28 days; 7) EQ-5D-5L at 28days, 90 days and 180 days; 8) BI at 28 days, 90 days and 180 days; 9) The cerebral edema volume at baseline, 24 hours, 7 days, 14 days or at discharge; 10) The hematoma volume at baseline, 24 hours, 7 days, 14 days or discharge; 11) The incidence of stroke-associated pneumonia (SAP) patients; 12) Clinical pulmonary infection score (CIPS) at the onset of SAP, 3 days, and 7 days, after the occurrence of SAP; 13) Chest imaging (DR/CT), body temperature, white blood cell count, C-reactive protein (CRP), procalcitonin (PCT) blood gas analysis, and sputum culture/airway aspirate culture at the onset of SAP, 3 days, and 7 days after the occurrence of SAP; 14) Antibiotic usage among patients with SAP.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Diagnosis of spontaneous ICH, confirmed by brain imaging;
- •Presentation within 48 hours of symptom onset (or last seen well);
- •Meet any of the following criteria: a) NIHSS ≥8, or b) GCS 7-14;
- •Provide written informed consent by patient (or approved surrogate);
排除标准
- •ICH secondary to a structural abnormality in the brain (e.g. cerebrovascular malformation, arterial aneurysm, tumour, Moyamoya disease, trauma, or previous ischaemic stroke), or secondary to presumed cerebrovascular amyloidosis, or secondary to reperfusion treatment for ischaemic stroke, or secondary to anticoagulant treatment, or secondary to antiplatelet treatment.
- •Unlikely to potentially benefit from therapy (e.g. advanced dementia) or judged by responsible treating clinician to have a high likelihood of early death irrespective of treatment;
- •Other medical illness that will interfere with outcome assessments and follow-up (e.g. known significant pre-stroke disability [modified Rankin scale {mRS} scores 4-5], advanced cancer and renal failure);
- •Known definite contraindication to the Chinese herbal medicine;
- •Women who are known to be pregnant or lactating;
- •Currently participating in another trial which would interfere with outcome assessments.
研究组 & 干预措施
Intervention group
Chinese herbal medicine FYTF-919: Oral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml * Q6H will be given through nasal feeding)
干预措施: Chinese herbal medicine FYTF-919 (Drug)
Control group
Placebo treatment: Oral liquid 33ml TID (or patients who are unconscious or dysphagia, a dose of 25ml * Q6H will be given through nasal feeding)
干预措施: Chinese herbal medicine FYTF-919 (Drug)
结局指标
主要结局
Utility-weighted modified Rankin scale scores
时间窗: 90 days after the treatment started
Utility-weighted modified Rankin scale scores. The value range from 0 to 10: higher scores mean a better outcome.
次要结局
- Utility-weighted mRS scores(180 days after the treatment started)
- Poor prognosis rate(28 days, 90 days and 180 days after the treatment started)
- NIHSS score(7 days and 28 days after the treatment started)
- Discharge rate(28 days after the treatment started)
- BI(28 days, 90 days and 180 days after the treatment started)
- Antibiotic usage(The onset of SAP, 3 days and 7 days after the occurrence of SAP)
- The cerebral edema volume(Baseline, 24 hours, 7 days, 14 days or at discharge)
- SAP(Baseline, 24 hours, 7 days, 14 days or discharge)
- Pulmonary infection(The onset of SAP, 3 days and 7 days after the occurrence of SAP)
- Mortality rate(28 days, 90 days and 180 days)
- 7 levels of mRS(28 days, 90 days and 180 days after the treatment started)
- The hematoma volume(Baseline, 24 hours, 7 days, 14 days or discharge)
- CPIS(The onset of SAP, 3 days and 7 days after the occurrence of SAP)
- European Quality of Life 5-dimensional questionnaire (EQ-5D-5L)(28 days, 90 days and 180 days after the treatment started)
研究者
jianwen guo, MD
Professor
Guangzhou University of Traditional Chinese Medicine