Trial Outcomes & Findings for Albumin for Intracerebral Hemorrhage Intervention (NCT NCT00990509)
NCT ID: NCT00990509
Last Updated: 2014-08-29
Results Overview
Hyperintense Acute injuRy Marker (HARM) characterizes the frequency and severity of blood brain barrier disruption. Mean HARM is assessed on the post-contrast study using a previously developed 5 point scale (0 to 5).). A score of 0 indicates no HARM, whereas a score of 5 indicates diffuse and generalized HARM. 11 of 14 participants received a Day 5 MRI. HARM reads could only be performed on 4 of the 7 placebo subjects due to insufficient sequences or presence of subarachnoid blood. Mean HARM score is presented.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Day 5 MRI
Results posted on
2014-08-29
Participant Flow
Participant milestones
| Measure |
Albumin
Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
Placebo
Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
9
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Albumin for Intracerebral Hemorrhage Intervention
Baseline characteristics by cohort
| Measure |
Albumin
n=5 Participants
Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
Placebo
n=9 Participants
Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
n=5 Participants
|
58.1 years
n=7 Participants
|
59.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 5 MRIHyperintense Acute injuRy Marker (HARM) characterizes the frequency and severity of blood brain barrier disruption. Mean HARM is assessed on the post-contrast study using a previously developed 5 point scale (0 to 5).). A score of 0 indicates no HARM, whereas a score of 5 indicates diffuse and generalized HARM. 11 of 14 participants received a Day 5 MRI. HARM reads could only be performed on 4 of the 7 placebo subjects due to insufficient sequences or presence of subarachnoid blood. Mean HARM score is presented.
Outcome measures
| Measure |
Albumin
Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
Placebo
n=4 Participants
Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
|---|---|---|
|
Mean Hyperintense Acute injuRy Marker (HARM)
|
—
|
NA points
Insufficient number of patients with outcome measure available for meaningful analysis as trial was stopped early. Analysis of a small number of observations would be misleading.
|
PRIMARY outcome
Timeframe: Through Day 90 following enrollmentSerious adverse events. Specific safety outcomes assessed: frank pulmonary edema as visualized on chest X-Ray, congestive heart failure, neurological deterioration (4-point worsening on NIHSS), death
Outcome measures
| Measure |
Albumin
n=5 Participants
Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
Placebo
n=9 Participants
Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
|---|---|---|
|
Assessment of Safety of Albumin Administration in Primary ICH
Serious Adverse Events
|
4 events
|
2 events
|
|
Assessment of Safety of Albumin Administration in Primary ICH
Pulmonary Edema
|
2 events
|
0 events
|
|
Assessment of Safety of Albumin Administration in Primary ICH
Congestive Heart Failure
|
0 events
|
0 events
|
|
Assessment of Safety of Albumin Administration in Primary ICH
Neurological Deterioration
|
1 events
|
0 events
|
|
Assessment of Safety of Albumin Administration in Primary ICH
Death
|
1 events
|
2 events
|
PRIMARY outcome
Timeframe: Day 5 MRI11 of 14 participants received a Day 5 MRI. Mean ICH volume based on 11 participants is presented.
Outcome measures
| Measure |
Albumin
n=4 Participants
Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
Placebo
n=7 Participants
Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
|---|---|---|
|
Mean Intracerebral Hemorrhage (ICH) Volume
|
41.2 cc
Standard Deviation 47.9
|
39.2 cc
Standard Deviation 31.5
|
Adverse Events
Albumin
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Albumin
n=5 participants at risk
Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
Placebo
n=9 participants at risk
Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment
Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.
MRIs will be with and without contrast will be performed at:
* Baseline
* 48 hours after enrollment(approximately Day 3)
* 96 hours after drug treatment begins (approximately Day 5)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
40.0%
2/5 • Number of events 2 • 90 Days
We did not collect non-serious adverse events.
|
0.00%
0/9 • 90 Days
We did not collect non-serious adverse events.
|
|
Nervous system disorders
Neurologic Deterioration
|
20.0%
1/5 • Number of events 1 • 90 Days
We did not collect non-serious adverse events.
|
0.00%
0/9 • 90 Days
We did not collect non-serious adverse events.
|
|
General disorders
Death
|
20.0%
1/5 • Number of events 1 • 90 Days
We did not collect non-serious adverse events.
|
22.2%
2/9 • Number of events 2 • 90 Days
We did not collect non-serious adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place