Ischemic StrokeCOADIHSNCT05974111
COAgulation Disorders in Ischaemic and Haemorrhagic Stroke
An observational study of Ischemic Stroke and Haemorrhagic Stroke, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Haemorrhagic Stroke, Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- blood sampling
- How many people
- 379 participants
- Where
- 1 siteBelgium
- Study dates
- 2 May 2023to 15 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- blood sampling
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: blood sampling | |
| 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 Receives: Diagnostic Test: blood sampling | |
| 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 Receives: Diagnostic Test: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Functional Outcome recurrent stroke
Recurrent stroke during first 3 months
Measured: 3 months
Vital Outcome - all cause mortality
Mortality rate in the participants of all cause at 3 months
Measured: 3 months
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
Measured: 3 months
Secondary outcomes (21)
ICU Length of stay
duration (days)
Measured: 3 months
Hospital Length of stay
duration (days)
Measured: 3 months
Need for mechanical ventilation in ICU
Yes/No and duration (days)
Measured: 3 months
Need for renal replacement therapy in ICU
YES / NO and duration (days)
Measured: 3 months
Deep vein thrombosis
Yes/No
Measured: 3 months
Need for ventriculo-external drain / ventriculo-peritoneal drain
Yes / No
Measured: 3 months
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
Measured: 3 months
Need for decompressive craniectomy
Yes / no
Measured: 3 months
Haemorrhagic transformation of infarction
yes / No
Measured: 3 months
Rebleeding aneurysm in aneurysmal subarachnoid haemorrhage
yes /no
Measured: 3 months
Rate of epilepsy
Both convulsive epileptic episode as non-convulsive epileptic episode. Both clinical diagnosis and elektro-encephalogram
Measured: 3 months
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
Measured: 3 months
Rate of Intensive Care Aquired weakness (ICUAW)
critical illness myopathy, critical illness polyneuropathy or icu-AW
Measured: 3 months
Rate of diabetes insipidus during first week
Diabetes insipidus
Measured: 7days
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
Measured: 7 days
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
Measured: 7 days
Rate of Acute kidney injury during first week
acute kidney injury (KDIGO classification)
Measured: 7 days
Rate of enteral feeding (oral/nasograstic) or Total parenteral nutrition during first week
TPN / enteral feeding (oral/nastrogastric)
Measured: 7 days
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
Measured: 7 days
Rate of infection during first week
CNS infection / pulmonary infection / endocarditis / UTI / GI infection /skin infection / blood stream infection
Measured: 7 days
Rate of antiplatelet / anticoagulant therapy during first week
Rate of antiplatelet therapy or anticoagulant therapy in participants
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start2 May 2023
- Primary completion2 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Synapse bv
- Responsible party
- Sponsor
- Investigators
- Hendrik Stragier, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974111
- Sponsor's protocol ID
- Z-2022142
- Acronym
- COADIHS
- Status last verified
- Aug 2026
- First submitted
- 30 May 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COAgulation Disorders in Ischaemic and Haemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT05974111
- Acronym / sponsor ID
- COADIHS / Z-2022142
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Synapse bv
- Study start
- 2 May 2023 (actual)
- Primary completion
- 2 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ischemic Stroke | – | Diagnostic Test: blood samplingPatients 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 |
| Haemorrhagic stroke | – | Diagnostic Test: blood samplingPatients 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 |
| Aneursmal Subarachnoid Haemorrhage | – | Diagnostic Test: blood samplingPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingAt 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 | Diagnostic test | Aneursmal Subarachnoid Haemorrhage, Haemorrhagic stroke, Ischemic Stroke |
Primary outcome
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
Functional Outcome recurrent stroke
Time frame: 3 months
Recurrent stroke during first 3 months
Vital Outcome - all cause mortality
Time frame: 3 months
Mortality rate in the participants of all cause at 3 months
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 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. 'unable to' * self-care 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. 'unable to' * usual activities 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. 'unable to' * pain/discomfort 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. extreme * anxiety / depression 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. extremely a global health score will be assessed
21 secondary outcomes
ICU Length of stay
Time frame: 3 months
Hospital Length of stay
Time frame: 3 months
Need for mechanical ventilation in ICU
Time frame: 3 months
Need for renal replacement therapy in ICU
Time frame: 3 months
Deep vein thrombosis
Time frame: 3 months
Need for ventriculo-external drain / ventriculo-peritoneal drain
Time frame: 3 months
Rate of delayed cerebral ischemia participants with aneurysmal subarachnoid haemorrhage
Time frame: 3 months
Need for decompressive craniectomy
Time frame: 3 months
Haemorrhagic transformation of infarction
Time frame: 3 months
Rebleeding aneurysm in aneurysmal subarachnoid haemorrhage
Time frame: 3 months
Rate of epilepsy
Time frame: 3 months
Rate of infection in participants
Time frame: 3 months
Rate of Intensive Care Aquired weakness (ICUAW)
Time frame: 3 months
Rate of diabetes insipidus during first week
Time frame: 7days
Rate of cardiovascular compromise during first week
Time frame: 7 days
Rate of acute respiratory failure during first week
Time frame: 7 days
Rate of Acute kidney injury during first week
Time frame: 7 days
Rate of enteral feeding (oral/nasograstic) or Total parenteral nutrition during first week
Time frame: 7 days
Rate of Acute liver failure during first week
Time frame: 7 days
Rate of infection during first week
Time frame: 7 days
Rate of antiplatelet / anticoagulant therapy during first week
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik Stragier, MD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Haemorrhagic Stroke, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcome Modified rankin scale (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.