COAgulation Disorders in Ischaemic and Haemorrhagic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sampling.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke, Haemorrhagic Stroke, Aneurysmal Subarachnoid Hemorrhage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test blood sampling
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
Primary outcome measures
- Functional Outcome Modified rankin scale [Time frame: 3 months]
- Functional Outcome recurrent stroke [Time frame: 3 months]
- Vital Outcome - all cause mortality [Time frame: 3 months]
- Functional Outcome EuroQol-5D [Time frame: 3 months]
Secondary outcome measures (12)
- ICU Length of stay [Time frame: 3 months]
- Hospital Length of stay [Time frame: 3 months]
- Need for mechanical ventilation in ICU [Time frame: 3 months]
- Need for renal replacement therapy in ICU [Time frame: 3 months]
- Deep vein thrombosis [Time frame: 3 months]
- Need for ventriculo-external drain / ventriculo-peritoneal drain [Time frame: 3 months]
- Rate of delayed cerebral ischemia participants with aneurysmal subarachnoid haemorrhage [Time frame: 3 months]
- Need for decompressive craniectomy [Time frame: 3 months]
- Haemorrhagic transformation of infarction [Time frame: 3 months]
- Rebleeding aneurysm in aneurysmal subarachnoid haemorrhage [Time frame: 3 months]
- Rate of epilepsy [Time frame: 3 months]
- Rate of infection in participants [Time frame: 3 months]
Eligibility criteria
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Ziekenhuis Oost-Limburg — Genk
Identifiers
NCT: NCT05974111 · Z-2022142