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.
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. Secondary Objective: * Detection of culprit underlying thrombophilia in cryptogenic stroke and evaluation of their effect on clinical course and outcome (recurrent stroke). * Evaluating the interaction between the coagulation profile and pre-stroke medication that works on coagulation pathways. * To investigate the role of platelets and platelet activation in different pathophysiological mechanisms described in development of delayed cerebral ischemia following aneurysmal subarachnoid haemorrhage (aSAH)(microvessel constriction, thromboinflammation, large artery vasospasm, cortical spreading depolarization) * To evaluate the role of haemostatic derangements following aSAH as biomarker to predict delayed cerebral ischemia.
Study Type
OBSERVATIONAL
Enrollment
350
At 5 time points (D0 (T0),morning after (T0B),D3 (T1),D5 (T2),D7(T3)) blood samples will be drawn next to blood sampling in context of standard of clinical care. A full coagulation and inflammation profile will be obtained as well as cell free DNA methylation
Ziekenhuis Oost-Limburg
Genk, Belgium
RECRUITINGFunctional Outcome Modified rankin scale
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
Time frame: 3 months
Functional Outcome recurrent stroke
Recurrent stroke during first 3 months
Time frame: 3 months
Vital Outcome - all cause mortality
Mortality rate in the participants of all cause at 3 months
Time frame: 3 months
Functional Outcome EuroQol-5D
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
Time frame: 3 months
ICU Length of stay
duration (days)
Time frame: 3 months
Hospital Length of stay
duration (days)
Time frame: 3 months
Need for mechanical ventilation in ICU
Yes/No and duration (days)
Time frame: 3 months
Need for renal replacement therapy in ICU
YES / NO and duration (days)
Time frame: 3 months
Deep vein thrombosis
Yes/No
Time frame: 3 months
Need for ventriculo-external drain / ventriculo-peritoneal drain
Yes / No
Time frame: 3 months
Rate of delayed cerebral ischemia participants with aneurysmal subarachnoid haemorrhage
Rate of delayed cerebral ischemia in participants with aneurysmal subarachnoid haemorrhage * vasospasm: clinical / radiological (transcranial doppler, CT perfusion, MRI) * Delayed cerebral ischemia as diagnosed with MRI
Time frame: 3 months
Need for decompressive craniectomy
Yes / no
Time frame: 3 months
Haemorrhagic transformation of infarction
yes / No
Time frame: 3 months
Rebleeding aneurysm in aneurysmal subarachnoid haemorrhage
yes /no
Time frame: 3 months
Rate of epilepsy
Both convulsive epileptic episode as non-convulsive epileptic episode. Both clinical diagnosis and elektro-encephalogram
Time frame: 3 months
Rate of infection in participants
CNS infection, Pulmonary infection, genito-urinary infection, catheter related blood stream infection,gastro-intestinal infection, skin infection, other infection, bacteriemia, fungaemia
Time frame: 3 months
Rate of Intensive Care Aquired weakness (ICUAW)
critical illness myopathy, critical illness polyneuropathy or icu-AW
Time frame: 3 months
Rate of diabetes insipidus during first week
Diabetes insipidus
Time frame: 7days
Rate of cardiovascular compromise during first week
As defined by use of vasopressors and inotropes / acute heart failure / acute myocardial infarction / cardiac arrest / new arrythmia / use of VA-ECMO
Time frame: 7 days
Rate of acute respiratory failure during first week
acute respiratory failure (intubation + mechanical ventilation / non-invasive ventilation / ARDS), need for VV-ECMO / neurogenic pulmonary edema
Time frame: 7 days
Rate of Acute kidney injury during first week
acute kidney injury (KDIGO classification)
Time frame: 7 days
Rate of enteral feeding (oral/nasograstic) or Total parenteral nutrition during first week
TPN / enteral feeding (oral/nastrogastric)
Time frame: 7 days
Rate of Acute liver failure during first week
Acute liver failure * INR \> 1.5 * Any grade of hepatic encefalopathy * No prior evidence of liver disease
Time frame: 7 days
Rate of infection during first week
CNS infection / pulmonary infection / endocarditis / UTI / GI infection /skin infection / blood stream infection
Time frame: 7 days
Rate of antiplatelet / anticoagulant therapy during first week
Rate of antiplatelet therapy or anticoagulant therapy in participants
Time frame: 7 days
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