COAgulation Disorders in Ischaemic and Haemorrhagic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 379
- 试验地点
- 2
- 主要终点
- Functional Outcome Modified rankin scale
研究概览
简要总结
In this study the investigators will assess both procoagulant and anticoagulant pathways using thrombin generation and platelet function tests; as well as neuronal ischemia using cell free DNA in all patients presenting with ischaemic and haemorrhagic stroke (including aneurysmal subarachnoid haemorraghe). Also the cross-talk between inflammation and thrombosis, so-called thrombo-inflammation is further investigated. As such the investigators aim to characterise the patient's coagulation profile before administration of any treatment. By assessing these pathways the investigators strive to detect specific markers to predict vital and functional outcome at 3 months in these patients. Finally the investigators may provide new pathophysiological insights in the course of disease following these events that can possibly improve future therapeutic strategies.
详细描述
In the COADIHS trial the main objective is to map the coagulation profile, both procoagulant and anticoagulant pathways, in patients presenting with acute ischaemic or haemorrhagic stroke.
By assessing these different pathways the investigators aim to detect possible biomarkers of coagulation with predictive value for functional and vital outcome at 3 months.
In different subgroup analyses the investigators try to answer additional research questions as posed by the specific pathophysiology.
Primary Objective:
Mapping the coagulation profile of both procoagulant and anticoagulant pathways together with markers of inflammation and ischemia in patients presenting with all types of acute ischaemic or haemorrhagic stroke, at presentation and during first 7 days of clinical course in order to detect biochemical markers with predictive value of vital and functional outcome at 3 months.
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
- •Presenting at the hospital with ischaemic stroke, haemorrhagic stroke, aneurysmal subarachnoid haemorrhage or any other type of non-traumatic, intracranial bleeding
- •In patients with minor ischemic stroke (NIHSS <= 4) only baseline lab sampling will be performed (T0 and T0B).
排除标准
- •Refusal of participation by patient or legal representative
- •Traumatic intracranial (subdural, subarachnoid, epidural haematoma) bleeding
- •Patients receiving treatment with interference on coagulation (pro / anti) before first sampling: in this group of patients the coagulation assessment at presentation will be excluded, further lab sampling is performed according to protocol.
- •Patients categorized as having stroke mimic will be excluded from analysis afterwards
研究组 & 干预措施
Ischemic Stroke
Patients presenting at emergency department / Intensive Care unit with ischemic stroke
- registration of baseline clinical data
- registration of baseline blood parameters (in context of standard of clinical care)
- additional blood sampling at 5 time points during 1st week with the purpose of full coagulation testing and cell free DNA methylation
干预措施: blood sampling (Diagnostic Test)
Haemorrhagic stroke
Patients presenting at emergency department / Intensive Care unit with haemorraghic stroke (spontaneous intracranial bleeding, no trauma)
- registration of baseline clinical data
- registration of baseline blood parameters (in context of standard of clinical care)
- additional blood sampling at 5 time points during 1st week with the purpose of full coagulation testing and cell free DNA methylation
干预措施: blood sampling (Diagnostic Test)
Aneursmal Subarachnoid Haemorrhage
Patients presenting at emergency department / Intensive Care unit with aneurysmal subarachnoid haemorrhage
- registration of baseline clinical data
- registration of baseline blood parameters (in context of standard of clinical care)
- additional blood sampling at 5 time points during 1st week with the purpose of full coagulation testing and cell free DNA methylation
干预措施: blood sampling (Diagnostic Test)
结局指标
主要结局
Functional Outcome Modified rankin scale
时间窗: 3 months
Modified Rankin Scale as defined by: score 0: no symptoms score 1: No significant disability despite symptoms; able to carry out all usual duties and activities Score 2:Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Score 3: Moderate disability; requiring some help, but able to walk without assistance Score 4:Moderately severe disability; unable to walk and attend to bodily needs without assistance Score 5: Severe disability; bedridden, incontinent and requiring constant nursing care and attention Score 6:Dead With Score 3-6 defined as poor outcome and score 0-2 defined as good outcome
Functional Outcome recurrent stroke
时间窗: 3 months
Recurrent stroke during first 3 months
Vital Outcome - all cause mortality
时间窗: 3 months
Mortality rate in the participants of all cause at 3 months
Functional Outcome EuroQol-5D
时间窗: 3 months
EuroQol-5D questionnaire scoring different aspects of functionality In each dimension a scale of 1-5 will be recorded, defined as: * mobility 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. 'unable to' * self-care 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. 'unable to' * usual activities 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. 'unable to' * pain/discomfort 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. extreme * anxiety / depression 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. extremely a global health score will be assessed
次要结局
- Rebleeding aneurysm in aneurysmal subarachnoid haemorrhage(3 months)
- Need for renal replacement therapy in ICU(3 months)
- Need for ventriculo-external drain / ventriculo-peritoneal drain(3 months)
- Rate of delayed cerebral ischemia participants with aneurysmal subarachnoid haemorrhage(3 months)
- Need for decompressive craniectomy(3 months)
- Rate of diabetes insipidus during first week(7days)
- Hospital Length of stay(3 months)
- Haemorrhagic transformation of infarction(3 months)
- ICU Length of stay(3 months)
- Rate of epilepsy(3 months)
- Rate of infection in participants(3 months)
- Need for mechanical ventilation in ICU(3 months)
- Deep vein thrombosis(3 months)
- Rate of Intensive Care Aquired weakness (ICUAW)(3 months)
- Rate of cardiovascular compromise during first week(7 days)
- Rate of acute respiratory failure during first week(7 days)
- Rate of Acute kidney injury during first week(7 days)
- Rate of enteral feeding (oral/nasograstic) or Total parenteral nutrition during first week(7 days)
- Rate of Acute liver failure during first week(7 days)
- Rate of infection during first week(7 days)
- Rate of antiplatelet / anticoagulant therapy during first week(7 days)