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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT01607151
Eligibility Criteria:
Inclusion Criteria:
* Spontaneous supratentorial ICH documented by CT scan within 18 hours after the onset of symptoms
* Admission to the Neuro-ICU
* Baseline hematoma \>15cc with or without IVH
* Need for mechanical ventilation.
Exclusion Criteria:
* GCS \<6
* Age \<18 years
* Pregnancy
* Pre-morbid modified Rankin Scale (mRS) \>2
* Do Not Resuscitate (DNR) order "prior" to enrollment
* Uncontrolled bleeding of different etiology (trauma, gastro-intestinal bleeding \[UGIB/LGIB\])
* Planned surgical decompression within 24 hours
* Secondary causes of ICH (ischemic stroke, coagulopathy \[INR\>1.4, aPTT\> 1.5 times baseline, thrombocytopenia platelets \<100,000/uL\], trauma, AVM, aneurysm, cerebral sinus thrombosis, or other causes)
* Evidence of sepsis
* Spontaneous hypothermia (core Temperature \<36C)
* Inability to obtain written informed consent
* Participation in another trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01607151
Study Brief:
Protocol Section:
NCT01607151