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The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke

NCT01684462 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2013-12-02

No results posted yet for this study

Summary

In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the patients occurred within 12 hours of acute ischemic stroke.

Conditions

  • Cerebral Infarction

Interventions

BIOLOGICAL

Human Serum Albumin 20

Human Serum Albumin 20% 100cc albumin 1.25g/kg up to 100g (500ml) intravenously infused over 4\~8h, commencing within 12 hours of stroke onset

DRUG

0.9 % Normal Saline

Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4\~8h, commencing within 12 hours of stroke onset

Sponsors & Collaborators

  • Green Cross Corporation

    collaborator INDUSTRY

  • Seoul St. Mary's Hospital

    lead OTHER

Principal Investigators

  • Kwang Soo Lee, M.D, Ph.D · Seoul St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01684462 on ClinicalTrials.gov