好色先生

好色先生

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Abstract Details

A Phase IIB Clinical Trial of Normobaric Oxygen Therapy (NBO) in Acute Ischemic Stroke (AIS)
Cerebrovascular Disease and Interventional Neurology
S02 - (-)
001
NBO may be a simple, feasible therapy that salvages acutely ischemic brain tissue and extends the time window for tPA.
tPA-ineligible subjects with imaging-confirmed AIS<9h and NIHSS>4 were randomized to NBO or Room Air (RA), delivered for 8h. There was no upper limit for age, NIHSS or stroke volume. NIHSS and MRI were obtained at 0h, 4h (during therapy), 24h, 48h, and 3mo.
The trial was prematurely terminated by DSMB after n=85 enrolled (NBO 43, RA 42) due to an imbalance in deaths (NBO 17 vs RA 7, p=0.03). Deaths were adjudicated as unrelated to therapy; 42% due to early care withdrawal due to massive baseline infarcts or moribund admission status and 29% died between day 21-106 from pre-existing conditions e.g. cancer. NBO and RA arms showed no difference in age (74 vs 73y), NIHSS (12.2卤7 vs 12.1卤6), ischemic lesion volume (103卤94 vs 77卤82 cc), or DEFUSE malignant profile (37% vs 34%, p=1.0). The NBO arm tended to have more women (63% vs 40%, p=0.05) and COPD (16% vs 2%, p=0.06). There was no significant difference in pre-specified outcomes for Safety [0-24h change in NIHSS, +0.17 vs -0.73, p=0.8; 0-48h percent lesion growth on CT or MRI, 100卤78% vs 82卤80%, p=0.5] or Efficacy [0-4h absolute change in NIHSS, -0.37 vs -0.43, p=0.83; 0-4h percent MRI lesion growth, 20卤31% vs 16卤28%, p=0.7]. Secondary Outcomes e.g. change in NIHSS, percent lesion growth until 3-mo, tissue reperfusion, and "% mismatch lost" in cases with DEFUSE target mismatch, were similar. There was no difference in rates of SAEs, brain edema, or brain hemorrhage.
NBO did not affect NIHSS or infarct growth in this trial. The observed imbalance in deaths remains unexplained, but appears unrelated to NBO. Further studies are warranted.
Authors/Disclosures
Aneesh B. Singhal, MD, FAAN (Massachusetts General Hospital)
PRESENTER 		An immediate family member of Dr. Singhal has received personal compensation for serving as an employee of Biogen. Dr. Singhal has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Medicolegal Firms. Dr. Singhal has received research support from NIH-NINDS. Dr. Singhal has received publishing royalties from a publication relating to health care. Dr. Singhal has received publishing royalties from a publication relating to health care. Dr. Singhal has received personal compensation in the range of $500-$4,999 for serving as a Honorarium (好色先生) with Biogen.
No disclosure on file
Kelly D. Foote, MD Kelly D. Foote, MD has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axio/Neurocrine Biosciences.