safety and efficacy study of a single dose of na-1 in patients undergoing endovascular repair of ruptured aneurysms

Conditions: Subarachnoid Hemorrhage; Ruptured Intracranial Aneurysm

Summary: this is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of na-1 in patients with subarachnoid hemorrhage (sah) undergoing endovascular repair of ruptured intracranial aneurysms. up to 300 male and female patients with sah undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed with 2.60 mg/kg of na-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on day 1 of the study period. subjects will undergo interim procedures at day 2-4, day 30-45, and end-of-study procedures on day 90.


Eligibility criteria:
inclusion criteria: * 1. a diagnosis of a ruptured brain aneurysm deemed suitable for repair by neuroendovascular techniques involving intraluminal occlusion by detachable platinum coils, or any neuroendovascular technique such as balloon-assisted coiling, stenting, or flowed diversion. * 2. patient should be grade ii-iv on the wfns grading scale for sah. * 3. male or female with a minimum age of 18 years on the day of enrolment. * 4. female subjects of childbearing potential: negative pregnancy test. * 5. non-surgically sterile males or males with partners of childbearing potential must be willing to use condoms with spermicide for 3 months after completion of dosing. * 6. body weight less than or equal to 180 kg. * 7. vital signs on admission: * blood pressure between 80-180 mm hg systolic/50-100 mm hg diastolic; * body temperature ≤ 38.5c. * 8. informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements. exclusion criteria: * 1. prior sah within 6 months of presentation. * 2. dissecting or mycotic brain aneurysm. * 3. planned endovascular vessel sacrifice as the primary modality for aneurysm treatment. * 4. known history of life-threatening allergic reaction to any medication. * 5. chronic renal disease defined as a baseline serum creatinine \> 150 µmol/l. * 6. women who are pregnant, or have a positive urine or blood (β-hcg) pregnancy test. * 7. women who are breastfeeding. * 8. any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol. * 9. pre-morbid (estimated) modified rankin scale score of \>1. * 10. previous major stroke. * 11. patients with known hiv infection. * 12. participation in a clinical trial with an investigational drug within 30 days preceding this study. * 13. previous participation in the enact trial (e.g, to treat a prior aneurysm), participation in another trial involving na-1 or prior receipt of na-1. * 14. any other medical condition that the site investigator deems would put the patient at excessive risk of participation in the study or an expected life expectancy less than 1 year or that would result in inability to collect clinical outcomes at 90 days.

Keywords: endovascular repair subarachnoid hemorrhage ruptured intracranial aneurysm stroke coiling na-1