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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT03743103
Eligibility Criteria:
Inclusion Criteria:
1. Signature of the TCLE by participant or companion.
2. Spontaneous intracerebral hemorrhage confirmed by computed tomography or magnetic resonance imaging and fit to be included in the study and initiate therapy with study medications within 6 hours after the event.
3. Intracerebral hemorrhage (volume \< 30 cm3).
4. No immediate surgical indication.
5. Both sexes, aged above 18 years.
6. Systolic blood pressure (\> 150 mmHg and \< 220 mmHg) measured on two occasions with a minimum difference of 2 minutes.
Exclusion Criteria:
1. Cerebral hemorrhage secondary to structural lesions in the brain, vascular malformations, coagulopathies or traumatic brain injury, if known at the time of randomization.
2. Participant in deep coma, defined by the Glasgow Coma Scale score of 3 to 5.
3. Uncontrolled asthmatic or COPD participants, if known at the time of randomization.
4. Participants with Grade IV Heart Failure, defined as heart rate \< 50 beats per minute.
5. Previous hemorrhagic stroke, if known at the time of randomization
6. Participants with Cerebral Vascular Stroke.
7. Participants who have presented previous ischemic cerebrovascular accident, if known at the time of randomization.
8. Chronic diseases with life expectancy less than 3 months.
9. Score ≥ 4 on the ICH score at the time of recruitment.
10. In use of anticoagulants in the last 48 hours, if known at the time of randomization.
11. Patients with contraindication to any of the study medications.
12. Intubation Orotraqueal on arrival at the service.
13. Pheochromocytoma, if known at the time of randomization.
14. Patients with hyperthyroidism, if known at the time of randomization.
15. Known pregnancy or breastfeeding . At the discretion of the investigator, an examination for confirmation may be requested.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03743103
Study Brief:
Protocol Section:
NCT03743103