Clinical trial NCT05974111: COAgulation Disorders in Ischaemic and Haemorrhagic Stroke
Official title: COAgulation Disorders in Ischaemic and Haemorrhagic Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Haemorrhagic Stroke
Aneurysmal Subarachnoid Hemorrhage
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
Collaborators: name: Synapse bv
First posted: 2023-08-03
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Functional Outcome Modified rankin scale
timeFrame: 3 months
measure: Functional Outcome recurrent stroke
timeFrame: 3 months
measure: Vital Outcome - all cause mortality
timeFrame: 3 months
measure: Functional Outcome EuroQol-5D
timeFrame: 3 months
Secondary outcomes:
measure: ICU Length of stay
timeFrame: 3 months
measure: Hospital Length of stay
timeFrame: 3 months
measure: Need for mechanical ventilation in ICU
timeFrame: 3 months
measure: Need for renal replacement therapy in ICU
timeFrame: 3 months
measure: Deep vein thrombosis
timeFrame: 3 months
measure: Need for ventriculo-external drain / ventriculo-peritoneal drain
timeFrame: 3 months
measure: Rate of delayed cerebral ischemia participants with aneurysmal subarachnoid haemorrhage
timeFrame: 3 months
measure: Need for decompressive craniectomy
timeFrame: 3 months
measure: Haemorrhagic transformation of infarction
timeFrame: 3 months
measure: Rebleeding aneurysm in aneurysmal subarachnoid haemorrhage
timeFrame: 3 months
measure: Rate of epilepsy
timeFrame: 3 months
measure: Rate of infection in participants
timeFrame: 3 months
measure: Rate of Intensive Care Aquired weakness (ICUAW)
timeFrame: 3 months
measure: Rate of diabetes insipidus during first week
timeFrame: 7days
measure: Rate of cardiovascular compromise during first week
timeFrame: 7 days
measure: Rate of acute respiratory failure during first week
timeFrame: 7 days
measure: Rate of Acute kidney injury during first week
timeFrame: 7 days
measure: Rate of enteral feeding (oral/nasograstic) or Total parenteral nutrition during first week
timeFrame: 7 days
measure: Rate of Acute liver failure during first week
timeFrame: 7 days
measure: Rate of infection during first week
timeFrame: 7 days
measure: Rate of antiplatelet / anticoagulant therapy during first week
timeFrame: 7 days
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Hendrik Stragier, MD
role: PRINCIPAL_INVESTIGATOR
References: