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NCT Number: NCT05974111

COAgulation Disorders in Ischaemic and Haemorrhagic Stroke

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.

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Key information

Conditions

Ischemic Stroke Aneurysmal Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Haemorrhagic Stroke Hemorrhage Hemorrhagic Stroke Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location status: Recruiting

Location contact

Hendrik Stragier, MD

CONTACT

[email protected]

+3289325277

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

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

Primary outcomes

  1. Functional Outcome Modified rankin scale

    Time frame: 3 months

    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

  2. Functional Outcome recurrent stroke

    Time frame: 3 months

    Recurrent stroke during first 3 months

  3. Vital Outcome - all cause mortality

    Time frame: 3 months

    Mortality rate in the participants of all cause at 3 months

  4. Functional Outcome EuroQol-5D

    Time frame: 3 months

    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

Secondary outcomes

  1. ICU Length of stay

    Time frame: 3 months

    duration (days)

  2. Hospital Length of stay

    Time frame: 3 months

    duration (days)

  3. Need for mechanical ventilation in ICU

    Time frame: 3 months

    Yes/No and duration (days)

  4. Need for renal replacement therapy in ICU

    Time frame: 3 months

    YES / NO and duration (days)

  5. Deep vein thrombosis

    Time frame: 3 months

    Yes/No

  6. Need for ventriculo-external drain / ventriculo-peritoneal drain

    Time frame: 3 months

    Yes / No

  7. Rate of delayed cerebral ischemia participants with aneurysmal subarachnoid haemorrhage

    Time frame: 3 months

    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

  8. Need for decompressive craniectomy

    Time frame: 3 months

    Yes / no

  9. Haemorrhagic transformation of infarction

    Time frame: 3 months

    yes / No

  10. Rebleeding aneurysm in aneurysmal subarachnoid haemorrhage

    Time frame: 3 months

    yes /no

  11. Rate of epilepsy

    Time frame: 3 months

    Both convulsive epileptic episode as non-convulsive epileptic episode. Both clinical diagnosis and elektro-encephalogram

  12. Rate of infection in participants

    Time frame: 3 months

    CNS infection, Pulmonary infection, genito-urinary infection, catheter related blood stream infection,gastro-intestinal infection, skin infection, other infection, bacteriemia, fungaemia

  13. Rate of Intensive Care Aquired weakness (ICUAW)

    Time frame: 3 months

    critical illness myopathy, critical illness polyneuropathy or icu-AW

  14. Rate of diabetes insipidus during first week

    Time frame: 7days

    Diabetes insipidus

  15. Rate of cardiovascular compromise during first week

    Time frame: 7 days

    As defined by use of vasopressors and inotropes / acute heart failure / acute myocardial infarction / cardiac arrest / new arrythmia / use of VA-ECMO

  16. Rate of acute respiratory failure during first week

    Time frame: 7 days

    acute respiratory failure (intubation + mechanical ventilation / non-invasive ventilation / ARDS), need for VV-ECMO / neurogenic pulmonary edema

  17. Rate of Acute kidney injury during first week

    Time frame: 7 days

    acute kidney injury (KDIGO classification)

  18. Rate of enteral feeding (oral/nasograstic) or Total parenteral nutrition during first week

    Time frame: 7 days

    TPN / enteral feeding (oral/nastrogastric)

  19. Rate of Acute liver failure during first week

    Time frame: 7 days

    Acute liver failure

    • INR > 1.5
    • Any grade of hepatic encefalopathy
    • No prior evidence of liver disease

  20. Rate of infection during first week

    Time frame: 7 days

    CNS infection / pulmonary infection / endocarditis / UTI / GI infection /skin infection / blood stream infection

  21. Rate of antiplatelet / anticoagulant therapy during first week

    Time frame: 7 days

    Rate of antiplatelet therapy or anticoagulant therapy in participants

Study contacts

Contact information is provided by the study sponsor or research team.

Hendrik Stragier, MD

CONTACT

[email protected]

+3289325277

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Collaborators

  • Synapse bv

Registry information

Acronym: COADIHS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2023
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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