Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT06648369
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic imaging proven diagnosis of non-traumatic ICH
* Vascular imaging (MR-/CT-angiogram or DSA) on admission to rule out high suspicion of macrovascular bleeding source
* Enrolment no later than 6 hours of symptom onset
* Age \>18 years, no upper age limit
* Informed consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent
Exclusion Criteria:
* Palliative care/comfort therapy decision in the emergency department
* ICH due to trauma (major head trauma \<24 hours of symptom onset causing loss of consciousness and thought to be sufficient to have caused the intracerebral bleeding)
* High suspicion of ICH due to arteriovenous malformation (AVM), aneurysm or sinus-venous-thrombosis confirmed by neuroimaging, brain tumor, vasculitis, RCVS/PRES or system disease (liver disease, inherit coagulopathy)
* Severe ICH (haematoma volume \>60ml or GCS \<8)
* Haematoma evacuation or decompressive craniectomy within 72 hours planned or highly likely (isolated EVD is not an exclusion criterion)
* Severe pre-morbid disability \[modified Rankin scale (mRS) is ≥4\]
* Contraindication against the use of tranexamic acid
* Active participation in another drug or devices trial concurrently
* Female patient that are either pregnant or breastfeeding
* Contraindications against Clevidipine (allergy to soja, lipid metabolism defect or known severe aortic stenosis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06648369
Study Brief:
Protocol Section:
NCT06648369