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COAgulation Disorders in Ischaemic and Haemorrhagic Stroke

ConditionsIschemic StrokeHaemorrhagic StrokeAneurysmal Subarachnoid Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZiekenhuis Oost-Limburg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

350 Participants
are divided into 3 treatment groups
Group A: Ischemic Stroke1 intervention
Group B: Haemorrhagic stroke1 intervention
Group C: Aneursmal Subarachnoid Haemorrhage1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 months
2

Functional Outcome recurrent stroke

Recurrent stroke during first 3 months

Time frame
3 months
3

Vital Outcome - all cause mortality

Mortality rate in the participants of all cause at 3 months

Time frame
3 months
4

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

Time frame
3 months

Secondary outcomes

1

ICU Length of stay

duration (days)

Time frame
3 months
2

Hospital Length of stay

duration (days)

Time frame
3 months
3

Need for mechanical ventilation in ICU

Yes/No and duration (days)

Time frame
3 months
4

Need for renal replacement therapy in ICU

YES / NO and duration (days)

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ziekenhuis Oost-Limburg

Lead sponsor

Synapse bv

Collaborator

Source ClinicalTrials.gov
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