NCT05891509招募中不适用
Efficacy and Safety of DTI-guided Minimally Invasive Hematoma Evacuation Versus Best Medical Therapy for Acute Spontaneous Intracerebral Hemorrhage: a Randomized Controlled Trial
Zhongming Qiu1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of score of 0-3 on the modified Rankin scale
研究概览
简要总结
Intracerebral hemorrhage (ICH) is a devastating disease with high early mortality, unfavorable neurological outcomes, and high cost of care. To date, the role of DTI-guided minimally invasive hematoma evacuation in ICH is still uncertain.
The investigators will conduct a multicenter randomized controlled trial, as well as a concurrent prospective observational study including all ICH patients who decline participation in the trial and will therefore receive minimally invasive hematoma evacuation or best medical therapy and consent to be followed up. All participants will be followed up at the same time using the same outcomes measures. The primary outcome will be collected by a blinded assessor.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old;
- •Intracerebral hemorrhage in the basal ganglia was diagnosed by CT examination;
- •The amount of bleeding is 20-40ml, and the midline structure is displaced horizontally by < 3mm in the pineal gland;
- •The degree of integrity and continuity of the corticospinal tract on the lesion side of magnetic resonance diffusion tensor imaging was graded as grade 2~4;
- •The time from onset to randomization is within 24 hours;
- •GCS score ≥ 4 points at randomization;
- •Muscle strength level 3 in the affected limb;
- •Written informed consent are provided by the patients or their legal representatives.
排除标准
- •Bleeding in other parts (e.g., bleeding in subtentorial areas such as thalamus, brainstem or cerebellum);
- •Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, bleeding transformation of large cerebral infarction, bleeding caused by β amyloidosis, bleeding caused by coagulation dysfunction) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-scale cerebral infarction, β amyloidosis, severe coagulation dysfunction;
- •Multiple intracranial hemorrhage;
- •Patients with ventricular hemorrhage or ICH rupture into the ventricles should consider the need for ventricular drainage;
- •Any history of brain parenchymal or other intracranial subarachnoid, subdural or epidural hemorrhage and surgical history in the past 30 days;
- •Myocardial infarction within the past 30 days;
- •Previous history of bleeding, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding that has not been completely controlled;
- •Hemoglobin < 100g/L, hematocrit <25%, platelet count < 100*109/L;
- •Receiving anticoagulant drugs such as warfarin, dabigatran or rivaroxaban within 1 week prior to enrollment, with an INR > 1.4;
- •Long-term anticoagulation and antiplatelet therapy are expected to be required;
- •Allergy to alpeplase, urokinase or surgery-related drugs and instruments;
- •Pregnant or lactating women;
- •Known high risk of embolism, including patients with mechanical heart valves implanted in the body, history of left heart thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is appropriate;
- •hypertension (systolic blood pressure is still greater than 180mmHg) that cannot be effectively controlled by aggressive antihypertensive therapy before randomization;
- •Life expectancy < 12 months in the advanced stage of any disease;
- •Participating in other interventional clinical studies.
结局指标
主要结局
Proportion of score of 0-3 on the modified Rankin scale
时间窗: 180 days after randomization
Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability.
次要结局
- Score of on the modified Rankin scale(180 days after randomization)
研究者
Zhongming Qiu
Professor
Xinqiao Hospital of Chongqing
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Study Evaluating the Safety and Efficacy of Neuroprotective Peptide CN-105 Peptide in Patients With Acute Supratentorial Intracerebral HemorrhageIntracerebral HemorrhageNCT06255977Beijing Tiantan Hospital240
Unknown
1 期
Non-invasive Evaluation of Cerebrovascular Reactivity in Spontaneous Intracerebral HemorrhageIntracerebral HemorrhageNCT03815513National Taiwan University Hospital60
招募中
不适用
Dutch Intracerebral Hemorrhage Surgery TrialIntracerebral HemorrhageMinimally Invasive Surgical ProceduresEndoscopic Surgical ProceduresNCT05460793Radboud University Medical Center600
已完成
不适用
Evaluation of Minimally Invasive Subcortical Parafascicular Access for Clot EvacuationCerebral HemorrhageNCT02331719Wake Forest University Health Sciences16
已完成
2 期
Normobaric Hyperoxia for Intracerebral HemorrhageNCT04144868Capital Medical University96