Image

COAgulation Disorders in Ischaemic and Haemorrhagic Stroke

COAgulation Disorders in Ischaemic and Haemorrhagic Stroke

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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

Study details
    Ischemic Stroke
    Haemorrhagic Stroke
    Aneurysmal Subarachnoid Hemorrhage

NCT05974111

Ziekenhuis Oost-Limburg

15 February 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.