Gregory W. Albers
Albumin in Acute Stroke (ALIAS) Trial - Part 2
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The ALIAS Trial consists of a multicenter, randomized, double-blind, parallel two-arm Phase III trial to assess whether IV ALB therapy confers neuroprotection in acute ischemic stroke over and above the standard of care among patients with acute ischemic stroke. Eligible subjects are randomized 1:1 to either ALB or saline and the primary outcome is assessed at the 3-month clinic visit. Subjects are followed for 12 months from randomization via telephone contact at 1, 6, 9 and 12 months to determine the durability of the effect of ALB therapy. Subjects may receive thrombolytic therapy and are expected to receive such therapy in a timely fashion according to the standard of care. Randomization is stratified according to whether or not the subject receives thrombolytic therapy.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Human Albumin
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to 83 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Acute ischemic stroke.
2. Age 18 years through 83 years (i.e., have not had their 84th birthday).
3. NIH Stroke Scale (NIHSS) score of 6 or greater as assessed immediately prior to thrombolysis treatment if patient is eligible for thrombolysis or immediately prior to randomization for patients not eligible for thrombolysis.
Initiation of ALB/placebo can begin within 5 hours of stroke onset, and within 60 minutes of the start of the thrombolysis infusion, if IV thrombolysis is given. [An exception is permitted in the case of subjects judged to be fully eligible for the ALIAS Trial pending confirmation of normal serum troponin level; in such a situation, an interval of up to 90 minutes between start of thrombolysis or randomization is permitted to allow for receipt of the serum troponin lab report.]
(The time of stroke onset is defined as the time at which the subject or observer first noted the onset of neurological abnormality. In the event that stroke symptoms were first noticed on awakening or were not witnessed, the time of onset is the last time the subject was observed to be normal or without stroke symptoms.)
4. Signed and dated informed consent has been obtained.
Key Exclusion Criteria:
1. Episode/exacerbation of congestive heart failure (CHF) from any cause in the last 6 months. (An episode of congestive heart failure is any heart failure that required a change in medication, diet or hospitalization.)
2. Known valvular heart disease with CHF in the last 6 months.
3. Known (or in the Investigator?s judgment) existence of severe aortic stenosis or mitral stenosis
4. Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months.
5. Acute myocardial infarction in the last 6 months.
6. Signs or symptoms of acute myocardial infarction, including EKG findings, on admission.
7. Elevated serum troponin level on admission > 0.1 mcg/L.
8. Suspicion of aortic dissection on admission.
9. Acute arrhythmia (including any tachy- or bradycardia) with hemodynamic instability on admission (systolic blood pressure < 100 mmHg).
10. Findings on physical examination of any of the following: (1) jugular venous distention (JVP > 4 cm above the sternal angle); (2) 3rd heart sound; (3) resting tachycardia (heart rate > 100/min) attributable to congestive heart failure; (4) abnormal hepatojugular reflux; (5) lower extremity pitting edema attributable to congestive heart failure; (6) bilateral rales; and/or (7) if a chest x-ray is performed, definite evidence of pulmonary edema, bilateral pleural effusion, or pulmonary vascular redistribution.
11. Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.
12. Historical modified Rankin Scale (mRS) greater to or equal to 2. Patients who live in a nursing home or who are not fully independent for activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.) immediately prior to the stroke are not eligible for the trial.
13. Patients with stroke occurring as a complication of hospitalization for another condition, or as a complication of a procedure.
14. Profound dehydration.
15. Fever, defined as core body temperature > 37.5C (99.5F).
16. Serum creatinine > 2.0 mg/dL or 180 micro mol/L.
17. Severe chronic anemia (hemoglobin < 7.5 g/dL or 75g/L).
18. Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan.
19. History of or known allergy to albumin.
20. History of or known allergy to natural rubber latex.
21. Pregnancy, breastfeeding or positive pregnancy test. (Women of childbearing age must have a negative pregnancy test prior to study drug administration.)
22. Concurrent participation in any other therapeutic clinical trial.
23. Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol, impair the assessment of outcome, or in which ALB therapy would be contraindicated or might cause harm to the subject.
Additional Study Details
Official Title:
A Phase III Randomized Multicenter Clinical Trial of HIgh Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic StrokeAnticipated start date:
3/23/2009Lead Sponsor:
University of MiamiCollaborator(s):
- Neurological Emergencies Treatment Trials Network
- University of Calgary
- Medical University of South Carolina
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- To determine whether albumin therapy increases the proportion of acute ischemic stroke patients with favorable outcome compared to placebo therapy at 3 months from randomization
Secondary Outcomes:
- Overall clinical outcome as assessed by the full scale of the modified Rankin Scale at three months post randomization
- Overall clinical outcome (as assessed by global statistical test of NIHSS, mRS, and BI scores) at 3 months post randomization
- Functional outcome as assessed by mRS and BI at 3 months post-randomization
- Neurological outcome as assessed by NIHSS score at 3 months post randomization
- Quality of Life as essessed by EuroQol at 3 months and 1 year post randomization, and by Stroke-Specific Quality of Life (SSQOL) instruments at 3 months post-randomization
- Robustness of albumin therapy as measured by a favorable outcome of mRS of 0 or 1 one year post randomization
- Incidence of recurrent ischemic stroke within 1 month, 3 months and 1 year post randomization, as assessed by the Questionnaire to Validate Stroke-Free Status (QVSFS)
- Mortality within 3 months and 1 year post randomization
- Incidence of symptomatic ICH within 24 (+/-6) hours of randomization
- Cognition measured at 3 months by Trailmaking A and B
Total Number to be Enrolled:
1100Total Number to be Enrolled at Stanford:
30More Information
Secondary ID(s):
- SQL# 98582
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
3/16/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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