albumin - publications

Predict more albumin - ligand interactions now!

1. Stroke. 2012 Jan 19. [Epub ahead of print]

The Albumin in Subarachnoid Hemorrhage (ALISAH) Multicenter Pilot Clinical Trial:
Safety and Neurologic Outcomes.

Suarez JI, Martin RH, Calvillo E, Dillon C, Bershad EM, Macdonald RL, Wong J,
Harbaugh R; for the ALISAH Investigators.

From the Department of Neurology, Baylor College of Medicine, Houston, TX; the
Division of Biostatistics and Epidemiology, Medical University of South Carolina,
Charleston, SC; the Department of Neurosurgery, University of Toronto, Toronto,
Ontario, Canada; the University of Calgary, Calgary, Alberta, Canada; and Penn
State University College of Medicine, Hershey, PA.

BACKGROUND AND PURPOSE: Human albumin has been shown to exert neuroprotective
effects in animal models of cerebral ischemia and humans with various
intracranial pathologies. We investigated the safety and tolerability of 25%
human albumin in patients with subarachnoid hemorrhage. METHODS: The Albumin in
Subarachnoid Hemorrhage (ALISAH) Pilot Clinical Trial was an open-label,
dose-escalation study. We intended to study 4 different dosages of albumin of
increasing magnitude (0.625 g/kg: Tier 1; 1.25 g/kg: Tier 2; 1.875 g/kg: Tier 3;
and 2.5 g/kg: Tier 4). Each dosage was to be given to 20 adult patients.
Treatment was administered daily for 7 days. We investigated the maximum
tolerated dose of albumin based on the rate of severe-to-life-threatening heart
failure and anaphylactic reaction and functional outcome at 3 months. RESULTS: We
treated 47 adult subjects: 20 in Tier 1; 20 in Tier 2; and 7 in Tier 3. We found
that doses ranging up to 1.25 g/kg/day×7 days were tolerated by patients without
major dose-limiting complications. We also found that outcomes trended toward
better responses in those subjects enrolled in Tier 2 compared with Tier 1 (OR,
3.0513; CI, 0.6586-14.1367) and with the International Intraoperative Hypothermia
for Aneurysm Surgery Trial cohort (OR, 3.1462; CI, 0.9158-10.8089). CONCLUSIONS:
Albumin in doses ranging up to 1.25 g/kg/day×7 days was tolerated by patients
with subarachnoid hemorrhage without major complications and may be
neuroprotective. Based on these results, planning of the ALISAH II, a Phase III,
randomized, placebo-controlled trial to test the efficacy of albumin, is
underway.Clinical Trial Registration-URL: Unique
identifier: NCT00283400.

PMID: 22267829 [PubMed - as supplied by publisher]