Albumin for Intracerebral Hemorrhage Intervention (ACHIEVE)

This study has been terminated.
(Enrollment was stopped due to low recruitment and the PI's move to a different institution.)
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Chelsea Kidwell, M.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT00990509
First received: October 1, 2009
Last updated: August 19, 2014
Last verified: August 2014
Results First Received: July 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Intracerebral Hemorrhage
Interventions: Drug: Albumin
Drug: Placebo
Procedure: Brain MRI with and without contrast

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Albumin

Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.

Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.

MRIs will be with and without contrast will be performed at:

  • Baseline
  • 48 hours after enrollment(approximately Day 3)
  • 96 hours after drug treatment begins (approximately Day 5)
Placebo

Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment

Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.

MRIs will be with and without contrast will be performed at:

  • Baseline
  • 48 hours after enrollment(approximately Day 3)
  • 96 hours after drug treatment begins (approximately Day 5)

Participant Flow:   Overall Study
    Albumin     Placebo  
STARTED     5     9  
COMPLETED     5     8  
NOT COMPLETED     0     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Albumin

Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.

Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.

MRIs will be with and without contrast will be performed at:

  • Baseline
  • 48 hours after enrollment(approximately Day 3)
  • 96 hours after drug treatment begins (approximately Day 5)
Placebo

Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment

Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.

MRIs will be with and without contrast will be performed at:

  • Baseline
  • 48 hours after enrollment(approximately Day 3)
  • 96 hours after drug treatment begins (approximately Day 5)
Total Total of all reporting groups

Baseline Measures
    Albumin     Placebo     Total  
Number of Participants  
[units: participants]
  5     9     14  
Age  
[units: years]
Mean ( Full Range )
  62.6  
  ( 41 to 82 )  
  58.1  
  ( 41 to 76 )  
  59.7  
  ( 41 to 82 )  
Gender  
[units: participants]
     
Female     0     3     3  
Male     5     6     11  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     3     5     8  
White     2     3     5  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     5     9     14  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     5     9     14  



  Outcome Measures
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1.  Primary:   Mean Hyperintense Acute injuRy Marker (HARM)   [ Time Frame: Day 5 MRI ]

2.  Primary:   Assessment of Safety of Albumin Administration in Primary ICH   [ Time Frame: Through Day 90 following enrollment ]

3.  Primary:   Mean Intracerebral Hemorrhage (ICH) Volume   [ Time Frame: Day 5 MRI ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There was an insufficient number of subjects in each treatment arm to allow for a meaningful analysis of the effects of albumin on HARM status (blood brain barrier disruption).


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chelsea Kidwell, MD
Organization: University of Arizona
phone: (520) 626-7159
e-mail: ckidwell@neurology.arizona.edu


No publications provided


Responsible Party: Chelsea Kidwell, M.D., Georgetown University
ClinicalTrials.gov Identifier: NCT00990509     History of Changes
Other Study ID Numbers: 2009-173
Study First Received: October 1, 2009
Results First Received: July 22, 2014
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration