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|NCT02636218 : Ketamine Infusion in Neurologic Deficit|
|Phase||Phase 2/Phase 3|
|Ages||Min: 18 Years Max: 70 Years|
1. Male or female 18 to 70 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.
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,
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
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
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.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02636218
| Link to official Clinicaltrials.gov listing