COAgulation Disorders in Ischaemic and Haemorrhagic Stroke

Ischemic Stroke Clinical Trial

— COADIHS  

Official title:

COAgulation Disorders in Ischaemic and Haemorrhagic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05974111
• Other study ID #: Z-2022142
• Status: Recruiting
• Start date: May 2, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: Hendrik Stragier, MD
• Phone: +3289325277
• Email: hendrik.stragier[@]zol.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: August 31, 2025
• Est. primary completion date: May 2, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Blood Coagulation Disorders
• Hemorrhage
• Hemorrhagic Stroke
• Hemostatic Disorders
• Ischemia
• Ischemic Stroke
• Stroke
• Subarachnoid Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (2)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg	Synapse bv

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Outcome Modified rankin scale	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 outcome	3 months
Primary	Functional Outcome recurrent stroke	Recurrent stroke during first 3 months	3 months
Primary	Vital Outcome - all cause mortality	Mortality rate in the participants of all cause at 3 months	3 months
Primary	Functional Outcome EuroQol-5D	EuroQol-5D questionnaire scoring different aspects of functionality; In each dimension a scale of 1-5 will be recorded, defined as: mobility; No problems; Slight problems; Moderate problems; Severe problems; 'unable to'; self-care; No problems; Slight problems; Moderate problems; Severe problems; 'unable to'; usual activities; No problems; Slight problems; Moderate problems; Severe problems; 'unable to'; pain/discomfort; No problems; Slight problems; Moderate problems; Severe problems; extreme; anxiety / depression; No problems; Slight problems; Moderate problems; Severe problems; extremely; a global health score will be assessed	3 months
Secondary	ICU Length of stay	duration (days)	3 months
Secondary	Hospital Length of stay	duration (days)	3 months
Secondary	Need for mechanical ventilation in ICU	Yes/No and duration (days)	3 months
Secondary	Need for renal replacement therapy in ICU	YES / NO and duration (days)	3 months
Secondary	Deep vein thrombosis	Yes/No	3 months
Secondary	Need for ventriculo-external drain / ventriculo-peritoneal drain	Yes / No	3 months
Secondary	Rate of delayed cerebral ischemia participants with aneurysmal subarachnoid haemorrhage	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 MRI	3 months
Secondary	Need for decompressive craniectomy	Yes / no	3 months
Secondary	Haemorrhagic transformation of infarction	yes / No	3 months
Secondary	Rebleeding aneurysm in aneurysmal subarachnoid haemorrhage	yes /no	3 months
Secondary	Rate of epilepsy	Both convulsive epileptic episode as non-convulsive epileptic episode. Both clinical diagnosis and elektro-encephalogram	3 months
Secondary	Rate of infection in participants	CNS infection, Pulmonary infection, genito-urinary infection, catheter related blood stream infection,gastro-intestinal infection, skin infection, other infection, bacteriemia, fungaemia	3 months
Secondary	Rate of Intensive Care Aquired weakness (ICUAW)	critical illness myopathy, critical illness polyneuropathy or icu-AW	3 months
Secondary	Rate of diabetes insipidus during first week	Diabetes insipidus	7days
Secondary	Rate of cardiovascular compromise during first week	As defined by use of vasopressors and inotropes / acute heart failure / acute myocardial infarction / cardiac arrest / new arrythmia / use of VA-ECMO	7 days
Secondary	Rate of acute respiratory failure during first week	acute respiratory failure (intubation + mechanical ventilation / non-invasive ventilation / ARDS), need for VV-ECMO / neurogenic pulmonary edema	7 days
Secondary	Rate of Acute kidney injury during first week	acute kidney injury (KDIGO classification)	7 days
Secondary	Rate of enteral feeding (oral/nasograstic) or Total parenteral nutrition during first week	TPN / enteral feeding (oral/nastrogastric)	7 days
Secondary	Rate of Acute liver failure during first week	Acute liver failure; INR > 1.5; Any grade of hepatic encefalopathy; No prior evidence of liver disease	7 days
Secondary	Rate of infection during first week	CNS infection / pulmonary infection / endocarditis / UTI / GI infection /skin infection / blood stream infection	7 days
Secondary	Rate of antiplatelet / anticoagulant therapy during first week	Rate of antiplatelet therapy or anticoagulant therapy in participants	7 days