Emergency Management of Spontaneous Intracerebral Haemorrhage - Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Assessment of the correlation between point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) and the functional recovery of SICH patients on day 180.
研究概览
简要总结
The bio-markers substudy of EsICH is designed to recruit patients with acute (first 8h) spontaneous intracerebral hemorrhage and assess a series of biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides) and point-of-care bio-markers (cTnI, hsCRP, D-Dimer) in order to predict the functional outcome of these patients and to determine their input for early risk stratification and prognosis.
详细描述
EsICH is designed as a multicenter double blind randomized (2:1) clinical trial assessing the effects of tranexamic acid (2g in total) on patients with acute (first 8h) spontaneous intracerebral hemorrhage.
The bio-markers substudy addresses the same category of patients and assesses biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides) and point-of-care bio-markers (cTnI, hsCRP, D-Dimer) in order to predict the functional outcome of these patients and to determine their input for early risk stratification and prognosis.
The patients with a diagnostic CT scan are recruited in the Emergency Departments or Neurology/ Neurosurgery Wards of the hospitals enrolled in the study and blood samples are drawn in the first 8h from the onset of the condition. The patient is then clinically assessed by the study investigators for the first 7 days of the admission and a second CT scan is performed on the second day (24h from the onset of the condition).
Telephone follow-ups will be completed on day 90 and 180 by the coordinating center of the study.
The bio-markers substudy is an observational, prospective multicenter (the study will be initially started in one center - Cluj-Napoca - and then the Tirgu Mures center will be activated. Two more centers might be also included on a later time - Alba and Bistrita-Nasaud, pending on financial and logistic reasons).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 over 18 years old
- •CT scan diagnosis of an spontaneous intracerebral hemorrhage in the first 8h from the onset of the condition
- •Informed consent
- •Access to telephone evaluations (landline or mobile phone for the participant or a family member)
排除标准
- •GCS < 8 points
- •Secondary cause of the intracerebral hemorrhage (trauma, known AVM, aneurysm, hemorrhagic transformation of an ischemic stroke, thrombosis of central veins and sinuses, thrombolitic therapy, tumors, infections).
- •Severe disability prior to this hemorrhagic event (modified Rankin Score =>4);
- •Known venous thrombembolic condition
- •History of coagulopathy (genetic or acquired)
- •Recent ischemic events (< 12 months) (ischemic stroke, myocardial infarction, peripheric artheriopathy)
- •History of seizures (or present condition)
- •Undergoing treatment with heparin, LMWH, GPIIb/IIIa antagonists or oral anticoagulants (warfarin/ acenocumarol, factor Xa inhibitors, thrombin inhibitors - in the last 14 days)
- •Pregnancy or breast feeding
- •Scheduled neurosurgical intervention on the next 24h
- •Ongoing of scheduled hemostatic treatment - prothrombin, vitamin K, fresh frozen plasma, platelets
- •Enrollment in other clinical trials in the last 30 days
- •Known terminal stage disease
结局指标
主要结局
Assessment of the correlation between point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) and the functional recovery of SICH patients on day 180.
时间窗: 180 days from the enrollment
Functional outcomes are defined as modified Rankin Score of 0 to 3 and Barthel Index of 60 to 100 points.
次要结局
- Assessment of the correlation between point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) and the hematoma volume.(2 days from the enrollment)
- Assessment of the correlation between point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) and the edema surrounding the bleeding site(2 days from the enrollment)
研究者
Eugenia-Maria Muresan
Coordinating Investigator
Iuliu Hatieganu University of Medicine and Pharmacy