Subarachnoid HemorrhagePhase 1ALISAHNCT01747408
Treatment of Subarachnoid Hemorrhage With Human Albumin
A Phase 1 study testing Human Albumin in people with Subarachnoid Hemorrhage, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The proposed study was set up to evaluate the tolerability and safety of 25% human albumin (HA) therapy in patients with subarachnoid hemorrhage (SAH). It is estimated that 37,500 people in the USA have SAH every year. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Human Albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to May 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (male or female) must be at least 18 but younger than 80 years of age.
- Onset of new neurological signs of subarachnoid hemorrhage within 72 hours at the time of evaluation and initiation of treatment with 25% human albumin.
- Clinical signs consistent with the diagnosis of subarachnoid hemorrhage including severe thunderclap headache, cranial nerve abnormalities, decreased level of consciousness, meningismus and focal neurological deficits.
- Head computed tomography demonstrates subarachnoid hemorrhage (rating scale 2-4).
- Cerebral angiography reveals the presence of saccular aneurysm(s) in a location that explains the subarachnoid hemorrhage.
- Treatment of cerebral aneurysm must be carried out prior to treatment initiation but within 72 hours of symptom onset. Accepted treatments of aneurysms include surgical clipping or endovascular embolization.
- Signed and dated informed written consent by the subject or his/her legally authorized representative.
Who cannot join
- Time of symptom onset cannot be reliably assessed.
- No demonstrable aneurysm by cerebral angiography.
- Evidence of traumatic, mycotic, or fusiform aneurysm by cerebral angiography.
- World Federation of Neurological Surgeons scale of IV and V
- Head computed tomography rating scale of 0 - 1
- History within the past 6 months, and/or physical findings on admission of decompensated heart failure (NYHA Class III and IV or heart failure requiring hospitalization).
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- Patient has received albumin prior to treatment assignment during the present admission.
- Hospitalization for or diagnosis of acute myocardial infarction within the preceding 3 months.
- Symptoms or electrocardiographic signs indicative of acute myocardial infarction on admission.
- Electrocardiographic evidence and/or physical findings compatible with second- or third-degree heart block, or of cardiac arrhythmia associated with hemodynamic instability.
- Echocardiogram performed before treatment revealing a left ventricular ejection fraction > or = 40% (if available).
- Serum creatinine > 2.0 mg/dl or creatinine clearance < 50 ml/min.
- Pregnancy, lactation or parturition within previous 30 days.
- Known allergy to albumin.
- Severe prior physical disability (Rankin Scale > 2) that precludes evaluation of clinical outcome measures.
- History of severe chronic obstructive lung disease (FEV1 < 50% predicted, increased shortness of breath, and repeated exacerbations which have an impact on patients' quality of life).
- History of confirmed or suspected liver failure (increased prothrombin time, elevated liver enzymes, hypoalbuminemia, and hyperbilirrubinemia with or without peripheral edema and encephalopathy)
- Current participation in another drug treatment protocol.
- Severe terminal disease with life expectancy less than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study was set up to evaluate the tolerability and safety of 25% human albumin (HA) therapy in patients with subarachnoid hemorrhage (SAH). It is estimated that 37,500 people in the USA have SAH every year. SAH is associated with a 51% mortality rate and one third of survivors are left functionally dependent. Cerebral vasospasm (CV) has been identified as the most important reason for neurological deterioration. CV may be due to multiple molecular mechanisms. The use of a neuroprotective agent with various actions, likes HA, would be important for prevention of CV and improved clinical outcome in patients with SAH. The proposed open-label, dose-escalation study will have important public health implications by providing necessary information for a definitive phase III clinical trial regarding the efficacy of treatment with HA in patients with SAH. The study was to enroll a maximum of 80 patients with SAH who meet the eligibility criteria. Four dosages of HA (0.625, 1.25, 1.875, and 2.5 g/kg) administered daily for seven days will be evaluated. The lowest dosage was to be evaluated in the first group of 20 subjects. A specific safety threshold was defined based on data from previous studies. The Data and Safety Monitoring Board approved or disapproved advancing to the next higher HA dosage based on the evaluation of the rate of congestive heart failure (CHF). The study assessed three outcomes: safety and tolerability of the HA dosages and the functional outcome. The primary tolerability outcome was defined as the subject's ability to receive the full allocated dose of HA without incurring frank CHF that requires termination of treatment. Secondary safety outcomes were serious adverse events (including neurological and medical complications, and anaphylactic reactions). Neurological complications comprise incidence of CV, rebleeding, hydrocephalus, and seizures after treatment. The three-month functional outcome determined, by Glasgow Outcome Scale, Barthel Index, modified Rankin Scale, NIH Stroke Scale and Stroke Impact Scale was measured to obtain a preliminary estimate of the treatment effect of HA. The timeline of the study is three years.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Human Albumin
- Keywords
- subarachnoid hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human AlbuminDrug
Also called Albumin
25% human albumin given in four escalating doses:
- Group 1: .625g/kg infused over 3hrs daily X 7day
- Group 2: 1.25g/kg infused over 3hrs daily X 7day
- Group 3: 1.875g/kg infused over 3hrs daily X 7day
- Group 4: 2.5g/kg infused over 3hrs daily X 7day
| Study group | Role | What they receive |
|---|---|---|
| 25% human albumin | Experimental | Subjects will be entered into one of 4 increasing dosages of 25% human albumin sequentially. Once the first 20 subjects have been enrolled and the DSMB reviews data and approves moving to the next dosage tier patients will be entered into the following dosage tier. Receives: Drug: Human Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participatns with cardiovascular adverse events as a measure of safety and tolerability
The study will investigate the number of patients experiencing moderate-to-severe acute heart failure for any given dosage tier directly related to treatment administration. Specifically, if at least 2 patients per dosage tier experience such serious event the study will be terminated.
Measured: Up to 48 hours after treatment administration
Secondary outcomes (4)
GOS
The study will measure the the Glasgow Outcome Scale to obtain preliminary estimates of treatment effects.
Measured: 3 months after enrollment
mRs
The study will measure the the modified Rankin Scale to obtain preliminary estimates of treatment effects.
Measured: 3 months after study enrollment
NIHSS
The study will measure the NIH Stroke Scale to obtain preliminary estimates of treatment effects.
Measured: 3 months after enrollment
SIS
The study will measure the Stroke Impact Scale to obtain preliminary estimates of treatment effects.
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startJun 2006
- Primary completionJul 2010
- Study completionMay 2011
Why it stopped: The study met the pre-specified criteria for stopping the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose I. Suarez, Baylor College of Medicine
- Investigators
- Jose I Suarez, MD, Study chair, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747408
- Sponsor's protocol ID
- H-21012
- Acronym
- ALISAH
- Status last verified
- Dec 2012
- First submitted
- 23 Jun 2011
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Subarachnoid Hemorrhage With Human Albumin
- ClinicalTrials.gov ID
- NCT01747408
- Acronym / sponsor ID
- ALISAH / H-21012
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- subarachnoid hemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study met the pre-specified criteria for stopping the trial
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study was set up to evaluate the tolerability and safety of 25% human albumin (HA) therapy in patients with subarachnoid hemorrhage (SAH). It is estimated that 37,500 people in the USA have SAH every year. SAH is associated with a 51% mortality rate and one third of survivors are left functionally dependent. Cerebral vasospasm (CV) has been identified as the most important reason for neurological deterioration. CV may be due to multiple molecular mechanisms. The use of a neuroprotective agent with various actions, likes HA, would be important for prevention of CV and improved clinical outcome in patients with SAH. The proposed open-label, dose-escalation study will have important public health implications by providing necessary information for a definitive phase III clinical trial regarding the efficacy of treatment with HA in patients with SAH. The study was to enroll a maximum of 80 patients with SAH who meet the eligibility criteria. Four dosages of HA (0.625, 1.25, 1.875, and 2.5 g/kg) administered daily for seven days will be evaluated. The lowest dosage was to be evaluated in the first group of 20 subjects. A specific safety threshold was defined based on data from previous studies. The Data and Safety Monitoring Board approved or disapproved advancing to the next higher HA dosage based on the evaluation of the rate of congestive heart failure (CHF). The study assessed three outcomes: safety and tolerability of the HA dosages and the functional outcome. The primary tolerability outcome was defined as the subject's ability to receive the full allocated dose of HA without incurring frank CHF that requires termination of treatment. Secondary safety outcomes were serious adverse events (including neurological and medical complications, and anaphylactic reactions). Neurological complications comprise incidence of CV, rebleeding, hydrocephalus, and seizures after treatment. The three-month functional outcome determined, by Glasgow Outcome Scale, Barthel Index, modified Rankin Scale, NIH Stroke Scale and Stroke Impact Scale was measured to obtain a preliminary estimate of the treatment effect of HA. The timeline of the study is three years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 25% human albumin | Experimental | Drug: Human AlbuminSubjects will be entered into one of 4 increasing dosages of 25% human albumin sequentially. Once the first 20 subjects have been enrolled and the DSMB reviews data and approves moving to the next dosage tier patients will be entered into the following dosage tier. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients (male or female) must be at least 18 but younger than 80 years of age.
Key exclusion criteria (19 listed)
- Time of symptom onset cannot be reliably assessed.
- No demonstrable aneurysm by cerebral angiography.
- Evidence of traumatic, mycotic, or fusiform aneurysm by cerebral angiography.
- World Federation of Neurological Surgeons scale of IV and V
- Head computed tomography rating scale of 0 - 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human AlbuminAlso: Albumin25% human albumin given in four escalating doses: 1. Group 1: .625g/kg infused over 3hrs daily X 7day 2. Group 2: 1.25g/kg infused over 3hrs daily X 7day 3. Group 3: 1.875g/kg infused over 3hrs daily X 7day 4. Group 4: 2.5g/kg infused over 3hrs daily X 7day | Drug | 25% human albumin |
Primary outcome
Number of participatns with cardiovascular adverse events as a measure of safety and tolerability
Time frame: Up to 48 hours after treatment administration
The study will investigate the number of patients experiencing moderate-to-severe acute heart failure for any given dosage tier directly related to treatment administration. Specifically, if at least 2 patients per dosage tier experience such serious event the study will be terminated.
4 secondary outcomes
GOS
Time frame: 3 months after enrollment
mRs
Time frame: 3 months after study enrollment
NIHSS
Time frame: 3 months after enrollment
SIS
Time frame: 3 months after enrollment
Results and safety
The study was stopped early (reason given: The study met the pre-specified criteria for stopping the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose I Suarez, MD study chair
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human Albumin in people with Subarachnoid Hemorrhage, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study met the pre-specified criteria for stopping the trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participatns with cardiovascular adverse events as a measure of safety and tolerability (time frame: Up to 48 hours after treatment administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2012.