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Treatment of Subarachnoid Hemorrhage With Human Albumin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00283400
Recruitment Status : Terminated (Study met safety endpoints)
First Posted : January 27, 2006
Results First Posted : April 1, 2015
Last Update Posted : April 1, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jose I. Suarez, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Subarachnoid Hemorrhage
Intervention Drug: 25% human albumin
Enrollment 47

Recruitment Details 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  
Arm/Group Title Dosage Tier 1 Dosage Tier 2 Dosage Tier 3 Dosage Tier 4
Hide Arm/Group Description 25% human albumin 0.625 g/kg 25% human albumin 1.25 g/kg 25% human albumin 1.875 g/kg 25% human albumin2.5 g/kg
Period Title: Overall Study
Started 20 20 7 0
Completed 18 19 6 0
Not Completed 2 1 1 0
Reason Not Completed
Withdrawal by Subject             1             1             0             0
Death             1             0             1             0
Arm/Group Title Dosage Tier 1 Dosage Tier 2 Dosage Tier 3 Dosage Tier 4 Total
Hide Arm/Group Description 25% human albumin 0.625 g/kg 25% human albumin 1.25 g/kg 25% human albumin 1.875 g/kg 25% human albumin 2.5 g/kg Total of all reporting groups
Overall Number of Baseline Participants 20 20 7 0 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 7 participants 0 participants 47 participants
<=18 years 0 0 0 0
Between 18 and 65 years 19 19 6 44
>=65 years 1 1 1 3
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 7 participants 0 participants 47 participants
51  (25) 51  (24) 55  (25) 51  (25)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 7 participants 0 participants 47 participants
Female 15 13 6 34
Male 5 7 1 13
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 7 participants 0 participants 47 participants
United States 15 12 4 31
Canada 5 8 3 16
1.Primary Outcome
Title Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome.
Hide Description Tolerability outcome: Subject's ability to receive the full allocated human albumin dose without incurring frank congestive heart failure or experiencing anaphylactic reactions that required discontinuation of the treatment. Study would be terminated if 2 or more subjects developed severe or life-threatening heart failure considered to be related (probably, possibly, and definitely) to albumin treatment.
Time Frame 9 days after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Sample size consideration for this Phase I dose-escalation study was based on the feasibility of recruiting patients in a 3-year study period at 5 sites.The recruitment yield would be a maximum of 80 patients or 20 patients per dosage group. Statistical analyses were mainly descriptive.
Arm/Group Title Dosage Tier 1 Dosage Tier 2 Dosage Tier 3 Dosage Tier 4
Hide Arm/Group Description:
25% human albumin 0.625 g/kg
25% human albumin 1.25 g/kg
25% human albumin 1.875 g/kg
25% human albumin 2.5 g/kg
Overall Number of Participants Analyzed 20 20 7 0
Measure Type: Number
Unit of Measure: participants
0 1 2
2.Secondary Outcome
Title Serious Adverse Events
Hide Description

Serious adverse events included neurological and medical complications and neurological deterioration.

Neurological deterioration was defined as a decline by more than 2 points in the Glasgow Coma Scale.

Time Frame within 3 months after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dosage Tier 1 Dosage Tier 2 Dosage Tier 3 Dosage Tier 4
Hide Arm/Group Description:
25% human albumin 0.625 g/kg
25% human albumin 1.25 g/kg
25% human albumin 1.875 g/kg
25% human albumin 2.5 g/kg
Overall Number of Participants Analyzed 20 20 7 0
Measure Type: Number
Unit of Measure: participants
Symptomatic Cerebral Vasospasm 4 3 2
Pulmonary Edema 2 2 0
ARDS 0 0 1
Rebleeding 1 0 0
Pulmonary Embolism 1 0 0
Gram-Negative Ventriculitis 1 0 0
Hypotension due to sepsis 1 0 0
3.Secondary Outcome
Title Good Clinical Outcome Was Defined as a Glasgow Outcome Scale Score of 0-1
Hide Description Number of subjects with good clinical outcome defined as a Glasgw Outcome Scale score of 0-1
Time Frame 3 months after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dosage Tier 1 Dosage Tier 2 Dosage Tier 3 Dosage Tier 4
Hide Arm/Group Description:
25% human albumin 0.625 g/kg
25% human albumin 1.25 g/kg
25% human albumin 1.875 g/kg
25% human albumin 2.5 g/kg
Overall Number of Participants Analyzed 20 20 7 0
Measure Type: Number
Unit of Measure: participants
13 17 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dosage Tier 1, Dosage Tier 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments Post-hoc comparison of outcomes in dosage tier 1 vs dosage tier 2.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.05
Confidence Interval (2-Sided) 95%
0.65 to 14.1
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dosage Tier 1 Dosage Tier 2 Dosage Tier 3 Dosage Tier 4
Hide Arm/Group Description 25% human albumin 0.625 g/kg 25% human albumin 1.25 g/kg 25% human albumin 1.875 g/kg 25% human albumin 2.5 g/kg
All-Cause Mortality
Dosage Tier 1 Dosage Tier 2 Dosage Tier 3 Dosage Tier 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dosage Tier 1 Dosage Tier 2 Dosage Tier 3 Dosage Tier 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/20 (25.00%)      3/20 (15.00%)      3/7 (42.86%)      0/0    
Cardiac disorders         
Severe or life-threatening acute heart failure   0/20 (0.00%)  0 1/20 (5.00%)  1 2/7 (28.57%)  2 0/0  0
Hypotension due to sepsis   1/20 (5.00%)  1 0/20 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Infections and infestations         
Sepsis   1/20 (5.00%)  1 0/20 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Gram-negative ventriculitis   1/20 (5.00%)  1 0/20 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Nervous system disorders         
Symptomatic Cerebral Vasospasm   4/20 (20.00%)  4 3/20 (15.00%)  3 2/7 (28.57%)  2 0/0  0
Rebleeding   1/20 (5.00%)  1 0/20 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Respiratory, thoracic and mediastinal disorders         
ARDS   0/20 (0.00%)  0 0/20 (0.00%)  0 1/7 (14.29%)  1 0/0  0
Pulmonary Embolism   1/20 (5.00%)  1 0/20 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Pulmonary edema   2/20 (10.00%)  2 2/20 (10.00%)  2 0/7 (0.00%)  0 0/0  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dosage Tier 1 Dosage Tier 2 Dosage Tier 3 Dosage Tier 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      0/7 (0.00%)      0/0    
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.
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
Other Publications:
Responsible Party: Jose I. Suarez, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00283400     History of Changes
Other Study ID Numbers: R01NS049135 ( U.S. NIH Grant/Contract )
R01NS049135 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2006
First Posted: January 27, 2006
Results First Submitted: February 5, 2013
Results First Posted: April 1, 2015
Last Update Posted: April 1, 2015