| Autor: |
Hill, Michael D., Moy, Claudia S., Palesch, Yuko Y., Martin, Renee, Dillon, Catherine R., Waldman, Bonnie Darcy, Patterson, Lynn, Mendez, Isabel M., Ryckborst, Karla J., Tamariz, Diego, Ginsberg, Myron D. |
| Předmět: |
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| Zdroj: |
International Journal of Stroke; Aug2007, Vol. 2 Issue 3, p214-219, 6p, 1 Chart |
| Abstrakt: |
Stroke is a serious global illness. Human albumin has emerged as a putative therapy for ischaemic stroke based on strong evidence from animal models. Following confirmation of the safety and feasibility of high-dose albumin treatment for acute ischaemic stroke in a pilot study, the Albumin in Acute Stroke trial, a phase 3 randomised, double-blinded, placebo-controlled clinical trial was initiated to evaluate the efficacy of high-dose albumin compared to saline control within 5 h of ischaemic stroke onset. Methods: The trial will enrol 1800 patients in two cohorts – a thrombolytic and a nonthrombolytic arm. High-dose (2 g/kg) human albumin will be administered in a 2-h straight intravenous infusion to ischaemic stroke patients, within 5 h of symptom onset. The primary outcome will be an NIH stroke scale score of 0–1 or a modified Rankin scale score of 0–1 at 90 days. Safety outcomes will include the incidence of congestive heart failure after study-drug administration. Results: Enrolment opened at 40 sites in August 2006; new sites continue to be added. Recruitment is ongoing and is projected to be completed by 2010. Conclusions: The trial will continue through 2010. The study is proceeding as planned. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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