Dodecafluoropentane Emulsion in Acute Ischemic Stroke: A Phase Ib/II Randomized and Controlled Dose-Escalation Trial
| Autor: | Taylor Witt, James D. Marsh, Robert D. Skinner, Rohan Sharma, Aliza T. Brown, Krishna Nalleballe, Paula K. Roberson, William C. Culp, Sanjeeva S. Onteddu |
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| Rok vydání: | 2018 |
| Předmět: |
Male
Time Factors Maximum Tolerated Dose Placebo Drug Administration Schedule 030218 nuclear medicine & medical imaging Dodecafluoropentane Emulsion law.invention Brain Ischemia 03 medical and health sciences Disability Evaluation 0302 clinical medicine Randomized controlled trial Double-Blind Method law Medicine Humans Radiology Nuclear Medicine and imaging Adverse effect Acute ischemic stroke Fluorocarbons Arkansas business.industry Incidence (epidemiology) Recovery of Function Middle Aged Clinical trial Stroke Neuroprotective Agents Treatment Outcome 030220 oncology & carcinogenesis Anesthesia Maximum tolerated dose Administration Intravenous Female Cardiology and Cardiovascular Medicine business |
| Zdroj: | Journal of vascular and interventional radiology : JVIR. 30(8) |
| ISSN: | 1535-7732 |
| Popis: | Purpose This randomized, placebo-controlled, double-blind, dose-escalation acute ischemic stroke trial was designed to demonstrate maximum tolerated dose, characterize adverse events (AEs), and explore clinical outcomes when intravenous dodecafluoropentane emulsion (DDFPe) was used as neuroprotection. Methods Acute ischemic stroke patients (n = 24) with National Institutes of Health Stroke Scale (NIHSS) score of 2–20 were randomized to either 3 doses of intravenous DDFPe or placebo, 1 every 90 minutes, starting within 12 hours of symptom onset. Doses were given without affecting standard stroke care. Each of the 3 dose cohorts included 8 patients, with 2 receiving placebo and 6 receiving DDFPe. Primary outcomes were serious adverse events (SAEs), AEs, NIHSS score, and modified Rankin Score (mRS). Results No dose-limiting toxicities were encountered, and no maximum tolerated dose was defined. One unrelated delayed death occurred in a DDFPe patient, and another occurred in the placebo group. Group SAEs and AEs were similar in incidence and severity. Early initiation of DDFPe treatment resulted in better NIHSS score response than late initiation (P = .03). Thirty- and 90-day mRS after high-dose therapy suggested clinical improvement (P = .01 and P = .03, respectively). However, the significance of differences in clinical outcomes was limited by small patient numbers and differences in stroke severity between cohorts. Conclusions Intravenous DDFPe appears to be safe at all doses tested. Clinical improvements in NIHSS score and mRS were significant but compromised by small sample size. |
| Databáze: | OpenAIRE |
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