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Treatment of Subarachnoid Hemorrhage With Human Albumin

This study has been terminated.
(Study met safety endpoints)
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jose I. Suarez, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00283400
First received: January 26, 2006
Last updated: March 18, 2015
Last verified: March 2015
Results First Received: February 5, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Subarachnoid Hemorrhage
Intervention: Drug: 25% human albumin

  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
The National Institutes of Health funded the Albumin in Subarachnoid Hemorrhage (ALISAH) pilot study, initiated in May 2006 and terminated in May 2010. The study was originally planned for 3 years but mostly due to the principal investigators transferring institutions and initiation of 2 non-US sites, 1 extra year was needed.

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
Dosage Tier 1 25% human albumin 0.625 g/kg
Dosage Tier 2 25% human albumin 1.25 g/kg
Dosage Tier 3 25% human albumin 1.875 g/kg
Dosage Tier 4 25% human albumin2.5 g/kg

Participant Flow:   Overall Study
    Dosage Tier 1     Dosage Tier 2     Dosage Tier 3     Dosage Tier 4  
STARTED     20     20     7     0  
COMPLETED     18     19     6     0  
NOT COMPLETED     2     1     1     0  
Withdrawal by Subject                 1                 1                 0                 0  
Death                 1                 0                 1                 0  



  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
Dosage Tier 1 25% human albumin 0.625 g/kg
Dosage Tier 2 25% human albumin 1.25 g/kg
Dosage Tier 3 25% human albumin 1.875 g/kg
Dosage Tier 4 25% human albumin 2.5 g/kg
Total Total of all reporting groups

Baseline Measures
    Dosage Tier 1     Dosage Tier 2     Dosage Tier 3     Dosage Tier 4     Total  
Number of Participants  
[units: participants]
  20     20     7     0     47  
Age  
[units: participants]
         
<=18 years     0     0     0         0  
Between 18 and 65 years     19     19     6         44  
>=65 years     1     1     1         3  
Age  
[units: years]
Mean (Standard Deviation)
  51  (25)     51  (24)     55  (25)         51  (25)  
Gender  
[units: participants]
         
Female     15     13     6         34  
Male     5     7     1         13  
Region of Enrollment  
[units: participants]
         
United States     15     12     4         31  
Canada     5     8     3         16  



  Outcome Measures
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1.  Primary:   Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome.   [ Time Frame: 9 days after enrollment ]

2.  Secondary:   Serious Adverse Events   [ Time Frame: within 3 months after enrollment ]

3.  Secondary:   Good Clinical Outcome Was Defined as a Glasgow Outcome Scale Score of 0-1   [ Time Frame: 3 months after enrollment ]


  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
Our study has several limitations. ALISAH is an early phase design and we do not have concurrent controls. In addition, the study was neither randomized nor powered to test for efficacy effects.


  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: Jose I Suarez, MD, Professor of Neurology
Organization: Baylor College of Medicine
phone: 713-798-8472
e-mail: jisuarez@bcm.edu


Publications of Results:
Other Publications:


Responsible Party: Jose I. Suarez, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00283400     History of Changes
Other Study ID Numbers: R01NS049135 ( US NIH Grant/Contract Award Number )
Study First Received: January 26, 2006
Results First Received: February 5, 2013
Last Updated: March 18, 2015
Health Authority: United States: Federal Government