Assessing coagulation disorders in stroke patients
COAgulation Disorders in Ischaemic and Haemorrhagic Stroke
This study is trying to understand blood clotting issues in stroke patients to see if certain markers can help predict their recovery after three months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ziekenhuis Oost-Limburg Academic / other |
| Locations | 1 site (Genk) |
| Trial ID | NCT05974111 on ClinicalTrials.gov |
What this trial studies
This observational study aims to map the coagulation profile, including both procoagulant and anticoagulant pathways, in patients presenting with acute ischemic or hemorrhagic stroke, including aneurysmal subarachnoid hemorrhage. The investigators will utilize thrombin generation and platelet function tests, along with measuring cell-free DNA to assess neuronal ischemia. By identifying specific biomarkers, the study seeks to predict vital and functional outcomes at three months post-stroke. Additionally, it will explore the interaction between inflammation and thrombosis, known as thrombo-inflammation, to provide insights that may enhance future therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates include patients presenting with ischemic stroke, hemorrhagic stroke, or aneurysmal subarachnoid hemorrhage.
Not a fit: Patients with traumatic intracranial bleeding or those receiving anticoagulant treatment prior to sampling may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of outcomes for stroke patients and inform future treatment strategies.
How similar studies have performed: Other studies have shown promise in mapping coagulation profiles in stroke patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Genk
- Ziekenhuis Oost-Limburg — Genk, Belgium (Recruiting)
Study contacts
- Principal investigator: Hendrik Stragier, MD — Ziekenhuis Oost-Limburg
- Study coordinator: Hendrik Stragier, MD
- Email: hendrik.stragier@zol.be
- Phone: +3289325277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.