COAgulation Disorders in Ischaemic and Haemorrhagic Stroke

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Functional Outcome Modified rankin scale [Срок оценки: 3 months]
• Functional Outcome recurrent stroke [Срок оценки: 3 months]
• Vital Outcome - all cause mortality [Срок оценки: 3 months]
• Functional Outcome EuroQol-5D [Срок оценки: 3 months]

Вторичные конечные точки (12)

• ICU Length of stay [Срок оценки: 3 months]
• Hospital Length of stay [Срок оценки: 3 months]
• Need for mechanical ventilation in ICU [Срок оценки: 3 months]
• Need for renal replacement therapy in ICU [Срок оценки: 3 months]
• Deep vein thrombosis [Срок оценки: 3 months]
• Need for ventriculo-external drain / ventriculo-peritoneal drain [Срок оценки: 3 months]
• Rate of delayed cerebral ischemia participants with aneurysmal subarachnoid haemorrhage [Срок оценки: 3 months]
• Need for decompressive craniectomy [Срок оценки: 3 months]
• Haemorrhagic transformation of infarction [Срок оценки: 3 months]
• Rebleeding aneurysm in aneurysmal subarachnoid haemorrhage [Срок оценки: 3 months]
• Rate of epilepsy [Срок оценки: 3 months]
• Rate of infection in participants [Срок оценки: 3 months]

Критерии участия

Критерии включения

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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бельгия · 1 центр

• Ziekenhuis Oost-Limburg — Genk

Идентификаторы

NCT: NCT05974111 · Z-2022142

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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