Trial · NCT00235495
Albumin in Acute Ischemic Stroke Trial
NCT00235495, Phase 3, Terminated, University of Miami; results first posted 2019-09-11
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ConductScience Library. Albumin in Acute Ischemic Stroke Trial. Trials, record NCT00235495. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00235495
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Albumin in Acute Ischemic Stroke Trial
- NCT number
- NCT00235495
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 841 participants, actual
- Lead sponsor
- University of Miami
- Conditions
- Ischemic Stroke
- Interventions
- Albumin, Saline
- First posted
- 2005-10-10
- Last updated
- 2019-12-17
- Results first posted
- 2019-09-11
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With Favorable Outcome Defined as National Institute of Health Stroke Scale (NIHSS) Score of 0-1 and/or Modified Rankin Scale (mRS) of 0-1. | at 3 months | The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of greater than 20 indicating severe neurologic deficit. The mRS ranges from 0-6 representing perfect health without symptoms to death. A score of 0 is no symptoms at all and a score of 1 is no significant disability. Able to carry out all usual duties and activities. |
| Secondary | Number of Participants With a Composite Outcome of mRS 0-1 and/or NIHSS 0-1 and/or Decrease in NIHSS From Baseline by 10 or More Points | at 3 months | |
| Secondary | Number of Participants With a NIHSS of 0-1 at 24 Hours | at 24 hours | The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of greater than 20 indicating severe neurologic deficit. |
| Secondary | Number of Participants With a NIHSS 0-1 at 90 Days. | at 90 days | The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of greater than 20 indicating severe neurologic deficit. |
| Secondary | The Number of Participants With a Score on the mRS 0-1 at 90 Days. | at 90 days | The mRS ranges from 0-6 representing perfect health without symptoms to death. 0 = No symptoms at all. 1 = No significant disability. Able to carry out all usual duties and activities. 2 = Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 = Moderate disability. Requires some help, but able to walk unassisted. 4 = Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 = Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 = Dead. |
| Secondary | The Number of Participants With a Score on the mRS of 0-2 at 90 Days. | at 90 days | The mRS ranges from 0-6 representing perfect health without symptoms to death. 0 = No symptoms at all. 1 = No significant disability. Able to carry out all usual duties and activities. 2 = Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 = Moderate disability. Requires some help, but able to walk unassisted. 4 = Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 = Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 = Dead. |
| Secondary | Number of Participants With a Favorable Outcome Per Modified Rankin Scare (mRS) | 90 days | Assessed as the final global disability level on the modified Rankin scale (mRS) at 90 days better than expectation (sliding dichotomy analysis) ) assessed in the intention to treat population. mRS Scale: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
| Secondary | Barthel Index (BI) 95-100 | at 90 days | The Barthel Index (BI) is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables - feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. the highest total score for fully independent subjects equals 100. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence. |
| Secondary | Number of Participants With an EuroQol (EQ-5D) Favorable Score < 0.78 | at 90 days | The EQ-5D measures the subject's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems) within a particular EQ-5D dimension. The EQ-5D results can be converted to health utility scores. |
| Secondary | Number of Participants With a Stroke Specific Quality of Life Scale (SSQOL) Score of >=3 | at 90 days | Stroke, specific, health-related quality of life (SSQoL) is a self-reported survey that includes 12 domains and 49 items which are scored on a 5pt Likert response format with a lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores. Each Domain Score and the Overall Total Score all range from 1-5 with 1 being worst and 5 being the best. We have presented data here for the number of participants that have an unweighted average of domain scores of 3 or greater. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants With Favorable Outcome Defined as National Institute of Health Stroke Scale (NIHSS) Score of 0-1 and/or Modified Rankin Scale (mRS) of 0-1. | at 3 months | Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Composite Outcome of mRS 0-1 and/or NIHSS 0-1 and/or Decrease in NIHSS From Baseline by 10 or More Points | at 3 months | Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a NIHSS of 0-1 at 24 Hours | at 24 hours | Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a NIHSS 0-1 at 90 Days. | at 90 days | Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants With a Score on the mRS 0-1 at 90 Days. | at 90 days | Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants With a Score on the mRS of 0-2 at 90 Days. | at 90 days | Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Favorable Outcome Per Modified Rankin Scare (mRS) | 90 days | Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Barthel Index (BI) 95-100 | at 90 days | Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized. | participants | NUMBER |
| SECONDARY | Number of Participants With an EuroQol (EQ-5D) Favorable Score < 0.78 | at 90 days | Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Stroke Specific Quality of Life Scale (SSQOL) Score of >=3 | at 90 days | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants With Favorable Outcome Defined as National Institute of Health Stroke Scale (NIHSS) Score of 0-1 and/or Modified Rankin Scale (mRS) of 0-1. | Albumin | 186 | Participants | ||
| The Number of Participants With Favorable Outcome Defined as National Institute of Health Stroke Scale (NIHSS) Score of 0-1 and/or Modified Rankin Scale (mRS) of 0-1. | Saline | 185 | Participants | ||
| Number of Participants With a Composite Outcome of mRS 0-1 and/or NIHSS 0-1 and/or Decrease in NIHSS From Baseline by 10 or More Points | Albumin | 227 | Participants | ||
| Number of Participants With a Composite Outcome of mRS 0-1 and/or NIHSS 0-1 and/or Decrease in NIHSS From Baseline by 10 or More Points | Saline | 241 | Participants | ||
| Number of Participants With a NIHSS of 0-1 at 24 Hours | Albumin | 65 | Participants | ||
| Number of Participants With a NIHSS of 0-1 at 24 Hours | Saline | 62 | Participants | ||
| Number of Participants With a NIHSS 0-1 at 90 Days. | Albumin | 65 | Participants | ||
| Number of Participants With a NIHSS 0-1 at 90 Days. | Saline | 62 | Participants | ||
| The Number of Participants With a Score on the mRS 0-1 at 90 Days. | Albumin | 155 | Participants | ||
| The Number of Participants With a Score on the mRS 0-1 at 90 Days. | Saline | 145 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Albumin | 422 | |
| Overall Study | STARTED | Saline | 419 | |
| Overall Study | COMPLETED | Albumin | 354 | |
| Overall Study | COMPLETED | Saline | 351 | |
| Overall Study | NOT COMPLETED | Albumin | 68 | |
| Overall Study | NOT COMPLETED | Saline | 68 |
Source ClinicalTrials.gov
Adverse events472
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 |
|---|---|---|---|---|---|---|
| other | FEVER | General disorders | Albumin | 38 | 422 | 42 |
| other | FEVER | General disorders | Saline | 34 | 419 | 35 |
| other | BACTEREMIA | Infections and infestations | Albumin | 3 | 422 | 3 |
| other | BACTEREMIA | Infections and infestations | Saline | 2 | 419 | 2 |
| other | SEPTICEMIA OR SEPTIC SHOCK | Blood and lymphatic system disorders | Albumin | 1 | 422 | 1 |
| other | SEPTICEMIA OR SEPTIC SHOCK | Blood and lymphatic system disorders | Saline | 3 | 419 | 3 |
| other | OROLINGUAL ANGIOEDEMA | Immune system disorders | Albumin | 1 | 422 | 1 |
| other | OROLINGUAL ANGIOEDEMA | Immune system disorders | Saline | 1 | 419 | 1 |
| other | RASH | Skin and subcutaneous tissue disorders | Albumin | 16 | 422 | 16 |
| other | RASH | Skin and subcutaneous tissue disorders | Saline | 14 | 419 | 16 |
1 to 10 of 472Source ClinicalTrials.gov
See all 472 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Albumin | ||
| Total, all-cause mortality | Saline | ||
| Total, other adverse events | Albumin | 352 | 422 |
| Total, other adverse events | Saline | 341 | 419 |
| Total, serious adverse events | Albumin | 212 | 422 |
| Total, serious adverse events | Saline | 178 | 419 |
Source ClinicalTrials.gov
Papers4
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 |
|---|---|---|---|---|---|
| U01NS054630 | Statistical and Data Coordinating Center for ALIAS and IMS 111 Trials | PALESCH, YUKO Y | MEDICAL UNIVERSITY OF SOUTH CAROLINA | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2005 to 2010 |
Source NIH RePORTER
Trial comparisons20
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Albumin vs Saline: Number of Participants With a Stroke Specific Quality of Life Scale (SSQOL) Score of >=3 | Trial comparisons |
| Albumin vs Saline: Recurrent Ischemic Stroke Within 30 Days | Trial comparisons |
| Albumin vs Saline: Atrial Fibrillation Within 48 Hours | Trial comparisons |
| Albumin vs Saline: Pulmonary Edema Within 48 Hours | Trial comparisons |
| Albumin vs Saline: Death Within 30 Days | Trial comparisons |
| Albumin vs Saline: Number of Participants With a Favorable Outcome Per Modified Rankin Scare (mRS) | Trial comparisons |
| Albumin vs Saline: Asymptomatic ICH Within 24 Hours | Trial comparisons |
| Albumin vs Saline: Shortness of Breath Within 48 Hours | Trial comparisons |
| Albumin vs Saline: Number of Participants With a NIHSS of 0-1 at 24 Hours | Trial comparisons |
| Albumin vs Saline: Number of Participants With Neurological Deterioration Within 48 Hours | Trial comparisons |
1 to 10 of 20
See all 20 trial comparisonsTests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
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/NCT00235495
GET https://conductscience.org/api/trials/v1/NCT00235495/registered?page=2