Trial Outcomes & Findings for Treatment of Subarachnoid Hemorrhage With Human Albumin (NCT NCT00283400)

Last Updated: 2015-04-01

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

47 participants

Primary outcome timeframe

9 days after enrollment

Results posted on

2015-04-01

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	20	20	7
Overall Study COMPLETED	18	19	6
Overall Study NOT COMPLETED	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	1	1	0	0
Overall Study Death	1	0	1	0

Baseline Characteristics

Treatment of Subarachnoid Hemorrhage With Human Albumin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dosage Tier 1 n=20 Participants 25% human albumin 0.625 g/kg	Dosage Tier 2 n=20 Participants 25% human albumin 1.25 g/kg	Dosage Tier 3 n=7 Participants 25% human albumin 1.875 g/kg	Dosage Tier 4 25% human albumin 2.5 g/kg	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	—	0 participants n=21 Participants
Age, Categorical Between 18 and 65 years	19 participants n=5 Participants	19 participants n=7 Participants	6 participants n=5 Participants	—	44 participants n=21 Participants
Age, Categorical >=65 years	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	—	3 participants n=21 Participants
Age, Continuous	51 years STANDARD_DEVIATION 25 • n=5 Participants	51 years STANDARD_DEVIATION 24 • n=7 Participants	55 years STANDARD_DEVIATION 25 • n=5 Participants	—	51 years STANDARD_DEVIATION 25 • n=21 Participants
Gender Female	15 participants n=5 Participants	13 participants n=7 Participants	6 participants n=5 Participants	—	34 participants n=21 Participants
Gender Male	5 participants n=5 Participants	7 participants n=7 Participants	1 participants n=5 Participants	—	13 participants n=21 Participants
Region of Enrollment United States	15 participants n=5 Participants	12 participants n=7 Participants	4 participants n=5 Participants	—	31 participants n=21 Participants
Region of Enrollment Canada	5 participants n=5 Participants	8 participants n=7 Participants	3 participants n=5 Participants	—	16 participants n=21 Participants

PRIMARY outcome

Timeframe: 9 days after enrollment

Population: 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.

Outcome measures

Outcome measures
Measure	Dosage Tier 1 n=20 Participants 25% human albumin 0.625 g/kg	Dosage Tier 2 n=20 Participants 25% human albumin 1.25 g/kg	Dosage Tier 3 n=7 Participants 25% human albumin 1.875 g/kg	Dosage Tier 4 25% human albumin 2.5 g/kg
Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome.	0 participants	1 participants	2 participants	—

SECONDARY outcome

Timeframe: within 3 months after enrollment

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.

Outcome measures

Outcome measures
Measure	Dosage Tier 1 n=20 Participants 25% human albumin 0.625 g/kg	Dosage Tier 2 n=20 Participants 25% human albumin 1.25 g/kg	Dosage Tier 3 n=7 Participants 25% human albumin 1.875 g/kg	Dosage Tier 4 25% human albumin 2.5 g/kg
Serious Adverse Events Symptomatic Cerebral Vasospasm	4 participants	3 participants	2 participants	—
Serious Adverse Events Pulmonary Edema	2 participants	2 participants	0 participants	—
Serious Adverse Events ARDS	0 participants	0 participants	1 participants	—
Serious Adverse Events Rebleeding	1 participants	0 participants	0 participants	—
Serious Adverse Events Pulmonary Embolism	1 participants	0 participants	0 participants	—
Serious Adverse Events Gram-Negative Ventriculitis	1 participants	0 participants	0 participants	—
Serious Adverse Events Hypotension due to sepsis	1 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: 3 months after enrollment

Number of subjects with good clinical outcome defined as a Glasgw Outcome Scale score of 0-1

Outcome measures

Outcome measures
Measure	Dosage Tier 1 n=20 Participants 25% human albumin 0.625 g/kg	Dosage Tier 2 n=20 Participants 25% human albumin 1.25 g/kg	Dosage Tier 3 n=7 Participants 25% human albumin 1.875 g/kg	Dosage Tier 4 25% human albumin 2.5 g/kg
Good Clinical Outcome Was Defined as a Glasgow Outcome Scale Score of 0-1	13 participants	17 participants	3 participants	—

Adverse Events

Dosage Tier 1

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Dosage Tier 2

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Dosage Tier 3

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Dosage Tier 4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dosage Tier 1 n=20 participants at risk 25% human albumin 0.625 g/kg	Dosage Tier 2 n=20 participants at risk 25% human albumin 1.25 g/kg	Dosage Tier 3 n=7 participants at risk 25% human albumin 1.875 g/kg	Dosage Tier 4 25% human albumin 2.5 g/kg
Respiratory, thoracic and mediastinal disorders ARDS	0.00% 0/20	0.00% 0/20	14.3% 1/7 • Number of events 1	— 0/0
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	5.0% 1/20 • Number of events 1	0.00% 0/20	0.00% 0/7	— 0/0
Infections and infestations Sepsis	5.0% 1/20 • Number of events 1	0.00% 0/20	0.00% 0/7	— 0/0
Cardiac disorders Severe or life-threatening acute heart failure	0.00% 0/20	5.0% 1/20 • Number of events 1	28.6% 2/7 • Number of events 2	— 0/0
Nervous system disorders Symptomatic Cerebral Vasospasm	20.0% 4/20 • Number of events 4	15.0% 3/20 • Number of events 3	28.6% 2/7 • Number of events 2	— 0/0
Nervous system disorders Rebleeding	5.0% 1/20 • Number of events 1	0.00% 0/20	0.00% 0/7	— 0/0
Infections and infestations Gram-negative ventriculitis	5.0% 1/20 • Number of events 1	0.00% 0/20	0.00% 0/7	— 0/0
Respiratory, thoracic and mediastinal disorders Pulmonary edema	10.0% 2/20 • Number of events 2	10.0% 2/20 • Number of events 2	0.00% 0/7	— 0/0
Cardiac disorders Hypotension due to sepsis	5.0% 1/20 • Number of events 1	0.00% 0/20	0.00% 0/7	— 0/0

Other adverse events

Adverse event data not reported

Additional Information

Jose I Suarez, MD, Professor of Neurology

Baylor College of Medicine

Phone: 713-798-8472

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place