NCT01684462

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 2, 2013

Status Verified

November 1, 2013

Enrollment Period

2 years

First QC Date

August 21, 2012

Last Update Submit

November 28, 2013

Conditions

Cerebral Infarction

Keywords

Acute Ischemic StrokeAlbumin

Outcome Measures

Primary Outcomes (1)

  • Average change in NIHSS

    Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h\~0days) and 14±3days

    at 14±3days

Secondary Outcomes (5)

  • NIHSS Score

    at 14±3days

  • Proportion of patients with improvement by NIHSS

    at 14±3days

  • modified Rankin Scale(mRS) favorable outcome

    at 3 months

  • Volume difference on diffusion MRI

    at 4 days±1days

  • Recurrent new ischemic lesions on diffusion MRI

    at 4±1days

Study Arms (2)

Human Serum Albumin 20

EXPERIMENTAL

Human Serum Albumin 20% 100cc intravenously infused over 4\~8h

Biological: Human Serum Albumin 20

0.9 % Normal saline

PLACEBO COMPARATOR

Treatment with same volume of normal saline

Drug: 0.9 % Normal Saline

Interventions

Human Serum Albumin 20BIOLOGICAL

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

Also known as: Human Serum Albumin Injection 20% 100ml Greencross
Human Serum Albumin 20
0.9 % Normal SalineDRUG

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

Also known as: 0.9 % Normal Saline ChoongWae INJ. 100ml
0.9 % Normal saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age less than 75 years old
  • Patients who can be administered ALbumin within 12hours of onset of acute ischemic stroke
  • ≤ NIHSS score \< 15
  • Patients who are agreed by guardian or legal representative in case that patients have no ability to join study voluntarily

You may not qualify if:

  • Medical history of congestive heart failure or patients who are judged congestive heart failure on admission.
  • Patients with cardiac edema or pulmonary edema.
  • Medical history of myocardial infarction within the past six months.
  • Patients who have serious aortic stenosis and mitral valve stenosis.
  • Signs or symptoms of acute MI on admission (Serum troponin level ≤0.1 ug/L)
  • Those Who had cardiac surgery.
  • Onset of cerebral infarction within the past three months.
  • Before onset of cerebral infarction, patients who were diagnosed as Historical mRS ≥ 2.
  • Patients who received treatment of thrombolysis or who planned for treatment of thrombolysis.
  • Acute tachyarrhythmia or bradyarrhythmia with hemodynamic instability on admission.
  • Acute or chronic lung disease requiring supplemental O2 therapy on admission
  • Severe anemia (Hb \< 8.0)
  • Severe dehydration (defined as decreased skin turgor, dry oral mucous membrane, tachycardia(\>100/min), and oliguria)
  • Fever, defined as core body temperature\>37.5 ℃
  • Serum creatinine \> 2.0 mg/dL
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St. Vincent's hospital

Suwon, Gyeonggido, South Korea

Location

Ewha Womans University Mokdong Hospital

Mokdong, Seoul, 158-710, South Korea

Location

Seoul St. Mary's Hospital

Seocho-Gu, Seoul, 137-701, South Korea

Location

Yeoudo St. Mary's hospital

Yeongdeungpo-gu, Seoul, 150-713, South Korea

Location

MeSH Terms

Conditions

Cerebral InfarctionIschemic Stroke

Interventions

Serum Albumin, HumanSaline Solution

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Serum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood ProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Kwang Soo Lee, M.D, Ph.D

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurology Professor

Study Record Dates

First Submitted

August 21, 2012

First Posted

September 13, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 2, 2013

Record last verified: 2013-11

Locations

KR(4)