COAgulation Disorders in Ischaemic and Haemorrhagic Stroke

NCT05974111 | Recruiting

• 1 other identifier: Z-2022142
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Haemorrhagic Stroke; Aneurysmal Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (4)

• 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

  3 months

Secondary Outcomes (21)

• 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

Study Arms (3)

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

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

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

Diagnostic Test: blood sampling

Interventions

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

Aneursmal Subarachnoid Haemorrhage; Haemorrhagic stroke; Ischemic Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• Synapse bv: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples stored in biobank for full coagulation testing. Moreover cell free DNA methylation will be assessed as marker of neuronal ischemia

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Subarachnoid Hemorrhage

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hendrik Stragier, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hendrik Stragier, MD

CONTACT

+3289325277; hendrik.stragier@zol.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: August 3, 2023
• Study Start: May 2, 2023
• Primary Completion: May 2, 2025
• Study Completion: August 31, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)