COAgulation Disorders in Ischaemic and Haemorrhagic Stroke
- Conditions
- Haemorrhagic StrokeAneurysmal Subarachnoid HemorrhageIschemic Stroke
- Interventions
- Diagnostic Test: blood sampling
- Registration Number
- NCT05974111
- Lead Sponsor
- Ziekenhuis Oost-Limburg
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
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).
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Aneursmal Subarachnoid Haemorrhage blood sampling 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 Haemorrhagic stroke blood sampling 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 Ischemic Stroke blood sampling 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
- Primary Outcome Measures
Name Time Method Vital Outcome - all cause mortality 3 months Mortality rate in the participants of all cause at 3 months
Functional Outcome Modified rankin scale 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 outcomeFunctional Outcome recurrent stroke 3 months Recurrent stroke during first 3 months
Functional Outcome EuroQol-5D 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
- Secondary Outcome Measures
Name Time Method Need for ventriculo-external drain / ventriculo-peritoneal drain 3 months Yes / No
Need for renal replacement therapy in ICU 3 months YES / NO and duration (days)
Rebleeding aneurysm in aneurysmal subarachnoid haemorrhage 3 months yes /no
Rate of delayed cerebral ischemia participants with aneurysmal subarachnoid haemorrhage 3 months 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 MRINeed for decompressive craniectomy 3 months Yes / no
Rate of diabetes insipidus during first week 7days Diabetes insipidus
Hospital Length of stay 3 months duration (days)
Haemorrhagic transformation of infarction 3 months yes / No
ICU Length of stay 3 months duration (days)
Rate of epilepsy 3 months Both convulsive epileptic episode as non-convulsive epileptic episode. Both clinical diagnosis and elektro-encephalogram
Rate of infection in participants 3 months CNS infection, Pulmonary infection, genito-urinary infection, catheter related blood stream infection,gastro-intestinal infection, skin infection, other infection, bacteriemia, fungaemia
Need for mechanical ventilation in ICU 3 months Yes/No and duration (days)
Deep vein thrombosis 3 months Yes/No
Rate of Intensive Care Aquired weakness (ICUAW) 3 months critical illness myopathy, critical illness polyneuropathy or icu-AW
Rate of cardiovascular compromise during first week 7 days As defined by use of vasopressors and inotropes / acute heart failure / acute myocardial infarction / cardiac arrest / new arrythmia / use of VA-ECMO
Rate of acute respiratory failure during first week 7 days acute respiratory failure (intubation + mechanical ventilation / non-invasive ventilation / ARDS), need for VV-ECMO / neurogenic pulmonary edema
Rate of Acute kidney injury during first week 7 days acute kidney injury (KDIGO classification)
Rate of enteral feeding (oral/nasograstic) or Total parenteral nutrition during first week 7 days TPN / enteral feeding (oral/nastrogastric)
Rate of Acute liver failure during first week 7 days Acute liver failure
* INR \> 1.5
* Any grade of hepatic encefalopathy
* No prior evidence of liver diseaseRate of infection during first week 7 days CNS infection / pulmonary infection / endocarditis / UTI / GI infection /skin infection / blood stream infection
Rate of antiplatelet / anticoagulant therapy during first week 7 days Rate of antiplatelet therapy or anticoagulant therapy in participants
Trial Locations
- Locations (1)
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium