Actively Recruiting
COAgulation Disorders in Ischaemic and Haemorrhagic Stroke Study to Map Coagulation and Inflammation Profiles and Predict Outcomes
Led by Ziekenhuis Oost-Limburg · Updated on 2024-11-14
350
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
Z
Ziekenhuis Oost-Limburg
Lead Sponsor
S
Synapse bv
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying coagulation disorders in patients with acute ischaemic stroke, haemorrhagic stroke, and aneurysmal subarachnoid haemorrhage. The main goal is to map both procoagulant and anticoagulant pathways, as well as inflammation and neuronal ischemia markers, to identify biochemical indicators that might predict survival and functional outcomes at three months. The study also explores underlying thrombophilia, the effects of pre-stroke medications, and platelet function related to delayed cerebral ischemia after aneurysmal subarachnoid haemorrhage. Participants receive care in emergency or intensive care settings where clinical and blood data are collected. Blood samples are taken at five time points during the first week after admission for detailed coagulation and cell-free DNA methylation testing, alongside standard clinical blood tests. Subgroups include patients with ischemic stroke, haemorrhagic stroke, and aneurysmal subarachnoid haemorrhage, each monitored closely to investigate specific pathophysiological mechanisms. During the study, patients have baseline clinical data and blood tests recorded with follow-up blood sampling within the first week. Researchers assess outcomes like functional status using scales at three months, mortality, stroke recurrence, and other clinical events such as intensive care needs and complications. The study provides detailed monitoring of coagulation and inflammatory markers to better understand disease progression and potential future treatments.
CONDITIONS
Brief Title
COAgulation Disorders in Ischaemic and Haemorrhagic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presenting at the hospital with ischemic stroke, hemorrhagic stroke, aneurysmal subarachnoid hemorrhage, or other non-traumatic brain bleeding
- Age 18 years or older
- Patients with minor ischemic stroke (NIHSS ≤ 4) will have only baseline lab sampling (T0 and T0B)
You will not qualify if you...
- Refusal of participation by patient or legal representative
- Traumatic intracranial bleeding (subdural, subarachnoid, epidural hematoma)
- Receiving treatment affecting coagulation before first sampling (coagulation assessment at presentation excluded)
- Patients diagnosed with stroke mimic excluded from analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at hospital presentation
Duration - 7 days
Participants have blood samples taken at 5 time points during the first week to map coagulation and inflammation profiles alongside standard clinical care.
5 blood sampling visits during first 7 days
Duration - 3 months
Participants are followed for 3 months to assess functional and vital outcomes after stroke.
Follow-up assessments at 3 months
Trial Site Locations
Total: 1 location
1
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Actively Recruiting
Research Team
H
Hendrik Stragier, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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