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Albumin in Acute Ischemic Stroke Trial

NCT00235495 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 841

Last updated 2019-12-17

Study results available
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Summary

The goal of the trial is to determine whether human albumin, administered within 5 hours of symptom onset, improves the 3-month outcome of subjects with acute ischemic stroke.

Conditions

Interventions

BIOLOGICAL

Albumin

human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset

DRUG

Saline

equivalent volume of isotonic saline control

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Calgary

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • Neurological Emergencies Treatment Trials Network (NETT)

    collaborator NETWORK

  • University of Miami

    lead OTHER

Principal Investigators

  • Myron D. Ginsberg, MD · University of Miami

  • Michael D. Hill, MD MSc · University of Calgary

  • Yuko Y Palesch, PhD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States
  • Canada
  • Finland
  • Israel

Study Locations

More Related Trials

Entities

Diseases

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 NCT00235495 on ClinicalTrials.gov