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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT02432157
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 to 70 inclusive
2. Hunt-Hess score of 1-5
3. Glascow Come Scale 4-15
4. Modified Fisher Grade 1-4
5. At least one reactive pupil
6. A brain CT/ MRI demonstrating SAH
7. DSA (digital subtraction angiogram) or CTA confirmed presence of intracranial aneurysm
8. The patient can be started on HTS within 72 hours of onset of symptoms of SAH
9. Previously placed central line or having other indication for central line placement
Exclusion Criteria:
1. Pregnancy, or inability to rule out pregnancy with a pregnancy test
2. A normal head CT scan or a CT scan showing a bleed that is not SAH
3. Spinal cord injury or other serious noncerebral injury
4. Known seizure disorder
5. Known brain disease (eg tumor, metastasis) or major psychiatric disorders (eg schizophrenia)
6. Renal insufficiency (baseline Cr\>1.5 mg/dl, CrCl\<30 ml/min, CKD)
7. Acute systolic dysfunction or congestive heart failure (CHF), with EF \<30%
8. Hematologic abnormalities or coagulopathy (PT\>20, PTT\>50, INR\>1.5, or bleeding time\>10sec)
9. Clinically significant cardiovascular, hepatic or pulmonary disease that, in the opinion of the investigator, would compromise patient safety
10. Other life-threatening injury that compromises patient survival through duration of study
11. Patient unlikely to be available for follow-up at 6 months after trial conclusion
12. Any concurrent relevant condition that makes the patient unsuitable for participation or follow-up
13. Serum sodium \> 155 mEq/L
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02432157
Study Brief:
Protocol Section:
NCT02432157