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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT02636218
Eligibility Criteria:
Inclusion Criteria:
1. Male or female 18 to 80 years old.
2. World Federation of Neurological Surgeons (WFNS) grade 2 to 4, obtained after resuscitation and prior to dosing.
3. SAH on admission cranial computed tomography (CT) scan (diffuse clot present in both hemispheres, thin or thick \[\>4 mm\], or local thick SAH (\>4 mm).
4. Ruptured saccular aneurysm, confirmed by catheter angiography (CA) or CT angiography (CTA) and treated by neurosurgical clipping or endovascular coiling.
5. External ventricular drain placed as part of routine care.
6. Able to be dosed within 4 hours of new neurologic deficit.
7. Historical modified Rankin score of 0 or 1.
8. Hemodynamically stable after resuscitation (systolic blood pressure \> 100 mm Hg)
9. Haemoglobin \>85 g/L, platelets \>125,000 cells/mm3
10. Informed consent.
11. New neurologic deficits that were not present previously, identified by 1) a decrease of 2 points on the modified Glasgow coma scale (mGCS) or 2) an increase in 2 points on the National Institute of Health Stroke Scale (NIHSS). i.e., a CODE VASOSPASM initiated in the ICU.
Exclusion Criteria:
1. Subarachnoid hemorrhage due to causes other than a saccular aneurysm (e.g., trauma or rupture of fusiform or infective aneurysm).
2. WFNS Grade 1 or 5 assessed after the completion of aneurysm repair.
3. Increased intracranial pressure (ICP) \>30 mm Hg in sedated patients lasting \>4 hours anytime since admission.
4. Intraventricular or intracerebral hemorrhage in absence of SAH or with only local, thin SAH.
5. Angiographic vasospasm prior to aneurysm repair procedure, as documented by catheter angiogram or CT angiogram.
6. Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion, or inability to secure the ruptured aneurysm.
7. Aneurysm repair requiring flow diverting stent or stent-assisted coiling and dual antiplatelet therapy.
8. Hemodynamically unstable prior to administration of study drug (i.e., SBP \<90 mm Hg, requiring \>6 L colloid or crystalloid fluid resuscitation).
9. Cardiopulmonary resuscitation was required following SAH.
10. Female patients with positive pregnancy test (blood or urine) at screening.
11. History within the past 6 months and/or physical finding on admission of decompensated heart failure (New York Heart Association \[NYHA\] Class III and IV or heart failure requiring hospitalization).
12. Acute myocardial infarction within 3 months prior to the administration of the study drug.
13. Symptoms or electrocardiogram (ECG)-based signs of acute myocardial infarction or unstable angina pectoris on admission.
14. Electrocardiogram evidence and/or physical findings compatible with second or third degree heart block or of cardiac arrhythmia associated with hemodynamic instability.
15. Echocardiogram, if performed as part of standard-of-care before treatment, revealing a left ventricular ejection fraction (LVEF) \<40%.
16. Severe or unstable concomitant condition or disease (e.g., known significant neurologic deficit, cancer, hematologic, or coronary disease), or chronic condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
17. Patients who have received an investigational product or participated in another interventional clinical study within 30 days prior to randomization.
18. Kidney disease as defined by plasma creatinine ≥2.5 mg/dl (221 umol/l); liver disease as defined by total bilirubin \>3 mg/dl (51.3 mmol/l); and/or known diagnosis or clinical suspicion of liver cirrhosis.
19. Known hypersensitivity or contraindication to ketamine per product monograph.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02636218
Study Brief:
Protocol Section:
NCT02636218