COAgulation Disorders in Ischaemic and Haemorrhagic Stroke

NCT ID: NCT05974111

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2025-08-31

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.

Conditions

Ischemic Stroke; Haemorrhagic Stroke; Aneurysmal Subarachnoid Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ischemic Stroke

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

blood sampling

Intervention Type: 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

Haemorrhagic stroke

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

blood sampling

Intervention Type: 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

Aneursmal Subarachnoid Haemorrhage

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

blood sampling

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synapse bv

INDUSTRY

Sponsor Role: collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hendrik Stragier, MD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Hendrik Stragier, MD

Role: CONTACT

hendrik.stragier@zol.be

+3289325277

Facility Contacts

Hendrik Stragier, MD

Role: primary

hendrik.stragier@zol.be

+3289325277

Other Identifiers

Z-2022142

Identifier Type: -

Identifier Source: org_study_id