PMID- 31349978
OWN - NLM
STAT- MEDLINE
DCOM- 20200302
LR  - 20200302
IS  - 1535-7732 (Electronic)
IS  - 1051-0443 (Linking)
VI  - 30
IP  - 8
DP  - 2019 Aug
TI  - Dodecafluoropentane Emulsion in Acute Ischemic Stroke: A Phase Ib/II Randomized 
      and Controlled Dose-Escalation Trial.
PG  - 1244-1250.e1
LID - S1051-0443(19)30411-7 [pii]
LID - 10.1016/j.jvir.2019.04.020 [doi]
AB  - 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.
CI  - Published by Elsevier Inc.
FAU - Culp, William C
AU  - Culp WC
AD  - Department of Radiology, University of Arkansas for Medical Science, 4301 West 
      Markham St., Little Rock, AR 72205. Electronic address: CulpWilliamC@uams.edu.
FAU - Onteddu, Sanjeeva S
AU  - Onteddu SS
AD  - Department of Neurology, University of Arkansas for Medical Science, 4301 West 
      Markham St., Little Rock, AR 72205.
FAU - Brown, Aliza
AU  - Brown A
AD  - 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.
FAU - Nalleballe, Krishna
AU  - Nalleballe K
AD  - Department of Neurology, University of Arkansas for Medical Science, 4301 West 
      Markham St., Little Rock, AR 72205.
FAU - Sharma, Rohan
AU  - Sharma R
AD  - Department of Radiology, University of Arkansas for Medical Science, 4301 West 
      Markham St., Little Rock, AR 72205.
FAU - Skinner, Robert D
AU  - Skinner RD
AD  - Department of Neurology, University of Arkansas for Medical Science, 4301 West 
      Markham St., Little Rock, AR 72205.
FAU - Witt, Taylor
AU  - Witt T
AD  - Department of Radiology, University of Arkansas for Medical Science, 4301 West 
      Markham St., Little Rock, AR 72205.
FAU - Roberson, Paula K
AU  - Roberson PK
AD  - Department of Biostatistics, University of Arkansas for Medical Science, 4301 
      West Markham St., Little Rock, AR 72205.
FAU - Marsh, James D
AU  - Marsh JD
AD  - Department of Internal Medicine, University of Arkansas for Medical Science, 4301 
      West Markham St., Little Rock, AR 72205.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Vasc Interv Radiol
JT  - Journal of vascular and interventional radiology : JVIR
JID - 9203369
RN  - 0 (Fluorocarbons)
RN  - 0 (Neuroprotective Agents)
RN  - 678-26-2 (perfluoropentane)
SB  - IM
MH  - Administration, Intravenous
MH  - Arkansas
MH  - Brain Ischemia/diagnosis/*drug therapy/physiopathology
MH  - Disability Evaluation
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Fluorocarbons/*administration & dosage/adverse effects
MH  - Humans
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Neuroprotective Agents/*administration & dosage/adverse effects
MH  - Recovery of Function
MH  - Stroke/diagnosis/physiopathology/*therapy
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2019/07/28 06:00
MHDA- 2020/03/03 06:00
CRDT- 2019/07/28 06:00
PHST- 2018/12/03 00:00 [received]
PHST- 2019/04/12 00:00 [revised]
PHST- 2019/04/17 00:00 [accepted]
PHST- 2019/07/28 06:00 [entrez]
PHST- 2019/07/28 06:00 [pubmed]
PHST- 2020/03/03 06:00 [medline]
AID - S1051-0443(19)30411-7 [pii]
AID - 10.1016/j.jvir.2019.04.020 [doi]
PST - ppublish
SO  - J Vasc Interv Radiol. 2019 Aug;30(8):1244-1250.e1. doi: 
      10.1016/j.jvir.2019.04.020.