NCT05974111|Completed
COAgulation Disorders in Ischaemic and Haemorrhagic Stroke
COADIHS
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COADIHS
Sponsor study identifier
observational
379
1 country
1
Study Start
May 2, 2023
Actual (reported)Primary Completion
August 2, 2025
Actual (reported)Study Completion
August 15, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 15, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2, 2023
Actual (reported)May 30, 2023
Actual (reported)August 3, 2023
Actual (reported)August 2, 2025
Actual (reported)August 15, 2025
Actual (reported)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
Functional Outcome recurrent stroke
Recurrent stroke during first 3 months
3 months
Vital Outcome - all cause mortality
Mortality rate in the participants of all cause at 3 months
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 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
ICU Length of stay
3 months
Hospital Length of stay
3 months
Need for mechanical ventilation in ICU
3 months
Need for renal replacement therapy in ICU
3 months
Deep vein thrombosis
3 months
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
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
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Blood samples stored in biobank for full coagulation testing. Moreover cell free DNA methylation will be assessed as marker of neuronal ischemia
Hendrik Stragier, MD
Ziekenhuis Oost-Limburg
379 participants (actual enrollment reported by the registry).
First Submitted
May 30, 2023
First Posted
August 3, 2023
Study Start
May 2, 2023
Actual (reported)Ex Vivo Evaluation of JAK-inhibitor and Gene Therapeutical Approach in JAK-STAT Related Disorders
Determinants of Vascular Leakage During Systemic Inflammatory Response Syndrome
3 months
Contact the study team to confirm eligibility.
Primary Completion
August 2, 2025
Actual (reported)Study Completion
August 15, 2025
Actual (reported)Last Updated
September 3, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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