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| Name | Class |
|---|---|
| Synapse bv | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ischemic Stroke | Patients presenting at emergency department / Intensive Care unit with ischemic stroke
|
| |
| Haemorrhagic stroke | Patients presenting at emergency department / Intensive Care unit with haemorraghic stroke (spontaneous intracranial bleeding, no trauma)
|
| |
| Aneursmal Subarachnoid Haemorrhage | Patients presenting at emergency department / Intensive Care unit with aneurysmal subarachnoid haemorrhage
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional 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 | 3 months |
| Functional Outcome recurrent stroke | Recurrent stroke during first 3 months | 3 months |
| Vital Outcome - all cause mortality | Mortality rate in the participants of all cause at 3 months | 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:
a global health score will be assessed | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Length of stay | duration (days) | 3 months |
| Hospital Length of stay | duration (days) | 3 months |
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Inclusion Criteria:
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).
Exclusion Criteria:
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The study population will consist of patients presenting at the hospital with ischaemic stroke, haemorrhagic stroke or aneurysmal subarachnoid haemorrhage.
As our hospital is a referral centre, both referred patients and patients presenting at our emergency department will be screened for eligibility.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hendrik Stragier, MD | Contact | +3289325277 | hendrik.stragier@zol.be |
| Name | Affiliation | Role |
|---|---|---|
| Hendrik Stragier, MD | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Recruiting | Genk | 3600 | Belgium |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood samples stored in biobank for full coagulation testing. Moreover cell free DNA methylation will be assessed as marker of neuronal ischemia
|
| Need for mechanical ventilation in ICU | Yes/No and duration (days) | 3 months |
| Need for renal replacement therapy in ICU | YES / NO and duration (days) | 3 months |
| Deep vein thrombosis | Yes/No | 3 months |
| Need for ventriculo-external drain / ventriculo-peritoneal drain | Yes / No | 3 months |
| Rate of delayed cerebral ischemia participants with aneurysmal subarachnoid haemorrhage | Rate of delayed cerebral ischemia in participants with aneurysmal subarachnoid haemorrhage
| 3 months |
| Need for decompressive craniectomy | Yes / no | 3 months |
| Haemorrhagic transformation of infarction | yes / No | 3 months |
| Rebleeding aneurysm in aneurysmal subarachnoid haemorrhage | yes /no | 3 months |
| Rate of epilepsy | Both convulsive epileptic episode as non-convulsive epileptic episode. Both clinical diagnosis and elektro-encephalogram | 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 | 3 months |
| Rate of Intensive Care Aquired weakness (ICUAW) | critical illness myopathy, critical illness polyneuropathy or icu-AW | 3 months |
| Rate of diabetes insipidus during first week | Diabetes insipidus | 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 | 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 | 7 days |
| Rate of Acute kidney injury during first week | acute kidney injury (KDIGO classification) | 7 days |
| Rate of enteral feeding (oral/nasograstic) or Total parenteral nutrition during first week | TPN / enteral feeding (oral/nastrogastric) | 7 days |
| Rate of Acute liver failure during first week | Acute liver failure
| 7 days |
| Rate of infection during first week | CNS infection / pulmonary infection / endocarditis / UTI / GI infection /skin infection / blood stream infection | 7 days |
| Rate of antiplatelet / anticoagulant therapy during first week | Rate of antiplatelet therapy or anticoagulant therapy in participants | 7 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |