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J Vasc Interv Radiol. 2019 Aug;30(8):1244-1250.e1. doi: 10.1016/j.jvir.2019.04.020.

Dodecafluoropentane Emulsion in Acute Ischemic Stroke: A Phase Ib/II Randomized and Controlled Dose-Escalation Trial.

Author information

1
Department of Radiology, University of Arkansas for Medical Science, 4301 West Markham St., Little Rock, AR 72205. Electronic address: CulpWilliamC@uams.edu.
2
Department of Neurology, University of Arkansas for Medical Science, 4301 West Markham St., Little Rock, AR 72205.
3
Department of Radiology, University of Arkansas for Medical Science, 4301 West Markham St., Little Rock, AR 72205; Department of Neurology, University of Arkansas for Medical Science, 4301 West Markham St., Little Rock, AR 72205.
4
Department of Radiology, University of Arkansas for Medical Science, 4301 West Markham St., Little Rock, AR 72205.
5
Department of Biostatistics, University of Arkansas for Medical Science, 4301 West Markham St., Little Rock, AR 72205.
6
Department of Internal Medicine, University of Arkansas for Medical Science, 4301 West Markham St., Little Rock, AR 72205.

Abstract

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.

PMID:
31349978
DOI:
10.1016/j.jvir.2019.04.020

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