Trial · NCT00283400
Treatment of Subarachnoid Hemorrhage With Human Albumin
NCT00283400, Not applicable, Terminated, Baylor College of Medicine; results first posted 2015-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Subarachnoid Hemorrhage With Human Albumin. Trials, record NCT00283400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00283400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Subarachnoid Hemorrhage With Human Albumin
- NCT number
- NCT00283400
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 47 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Subarachnoid Hemorrhage
- Interventions
- 25% human albumin
- First posted
- 2006-01-27
- Last updated
- 2015-04-01
- Results first posted
- 2015-04-01
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome. | 9 days after enrollment | 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. |
| Secondary | Serious Adverse Events | 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. |
| Secondary | Good Clinical Outcome Was Defined as a Glasgow Outcome Scale Score of 0-1 | 3 months after enrollment | Number of subjects with good clinical outcome defined as a Glasgw Outcome Scale score of 0-1 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome. | 9 days after enrollment | 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. | participants | NUMBER |
| SECONDARY | Serious Adverse Events | within 3 months after enrollment | participants | NUMBER | |
| SECONDARY | Good Clinical Outcome Was Defined as a Glasgow Outcome Scale Score of 0-1 | 3 months after enrollment | participants | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome. | Dosage Tier 1 | 0 | participants | ||
| Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome. | Dosage Tier 2 | 1 | participants | ||
| Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome. | Dosage Tier 3 | 2 | participants | ||
| Serious Adverse Events | Dosage Tier 1 | Symptomatic Cerebral Vasospasm | 4 | participants | |
| Serious Adverse Events | Dosage Tier 2 | Symptomatic Cerebral Vasospasm | 3 | participants | |
| Serious Adverse Events | Dosage Tier 3 | Symptomatic Cerebral Vasospasm | 2 | participants | |
| Serious Adverse Events | Dosage Tier 1 | Pulmonary Edema | 2 | participants | |
| Serious Adverse Events | Dosage Tier 2 | Pulmonary Edema | 2 | participants | |
| Serious Adverse Events | Dosage Tier 3 | Pulmonary Edema | 0 | participants | |
| Serious Adverse Events | Dosage Tier 1 | ARDS | 0 | participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dosage Tier 1 | 20 | |
| Overall Study | STARTED | Dosage Tier 2 | 20 | |
| Overall Study | STARTED | Dosage Tier 3 | 7 | |
| Overall Study | STARTED | Dosage Tier 4 | 0 | |
| Overall Study | COMPLETED | Dosage Tier 1 | 18 | |
| Overall Study | COMPLETED | Dosage Tier 2 | 19 | |
| Overall Study | COMPLETED | Dosage Tier 3 | 6 | |
| Overall Study | COMPLETED | Dosage Tier 4 | 0 | |
| Overall Study | NOT COMPLETED | Dosage Tier 1 | 2 | |
| Overall Study | NOT COMPLETED | Dosage Tier 2 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | ARDS | Respiratory, thoracic and mediastinal disorders | Dosage Tier 1 | 0 | 20 | 0 |
| serious | ARDS | Respiratory, thoracic and mediastinal disorders | Dosage Tier 2 | 0 | 20 | 0 |
| serious | ARDS | Respiratory, thoracic and mediastinal disorders | Dosage Tier 3 | 1 | 7 | 1 |
| serious | ARDS | Respiratory, thoracic and mediastinal disorders | Dosage Tier 4 | 0 | 0 | 0 |
| serious | Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Dosage Tier 1 | 1 | 20 | 1 |
| serious | Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Dosage Tier 2 | 0 | 20 | 0 |
| serious | Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Dosage Tier 3 | 0 | 7 | 0 |
| serious | Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Dosage Tier 4 | 0 | 0 | 0 |
| serious | Sepsis | Infections and infestations | Dosage Tier 1 | 1 | 20 | 1 |
| serious | Sepsis | Infections and infestations | Dosage Tier 2 | 0 | 20 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dosage Tier 1 | ||
| Total, all-cause mortality | Dosage Tier 2 | ||
| Total, all-cause mortality | Dosage Tier 3 | ||
| Total, all-cause mortality | Dosage Tier 4 | ||
| Total, other adverse events | Dosage Tier 1 | 0 | 20 |
| Total, other adverse events | Dosage Tier 2 | 0 | 20 |
| Total, other adverse events | Dosage Tier 3 | 0 | 7 |
| Total, other adverse events | Dosage Tier 4 | 0 | 0 |
| Total, serious adverse events | Dosage Tier 1 | 5 | 20 |
| Total, serious adverse events | Dosage Tier 2 | 3 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers11
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS049135 | Treatment of Subarachnoid Hemorrhage with Human Albumin | SUAREZ, JOSE I | BAYLOR COLLEGE OF MEDICINE | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00283400
GET https://conductscience.org/api/trials/v1/NCT00283400/results?page=2