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Intracerebral HemorrhagePhase 2ACHIEVENCT00990509

Albumin for Intracerebral Hemorrhage Intervention

A Phase 2 study testing Albumin and Brain MRI with and without contrast in people with Intracerebral Hemorrhage, run by Georgetown University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to find out what effects, good and bad, the medication Albumin has on subjects who have experienced a type of stroke known as an intracerebral hemorrhage (ICH). An ICH is when spontaneous bleeding into the brain occurs due to fragile blood vessels. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
Albumin and Brain MRI with and without contrast
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14 participants
Where
1 siteUnited States
Study dates
Sep 2009to Jun 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary supratentorial ICH
  • < 48 hours from symptom onset
  • Age >18
  • Signed informed consent obtained from the patient or patient's legally authorized representative

Who cannot join

  • ICH volume < 5 cc
  • Glasgow Coma Scale < 6
  • Surgical evacuation anticipated
  • Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
  • Pregnancy or breastfeeding
  • Hemodynamic instability (SBP < 100 mmHg, > 200 mmHg)
Show all 23Show fewer
  • Current participation in another experimental treatment protocol
  • Renal impairment with GFR < 30 or Creatinine > 2.0
  • History of or known allergy to albumin
  • History of or known severe allergy to rubber latex
  • 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)
  • Acute myocardial infarction in the last 6 months
  • Elevated serum troponin level on admission > 0.1 mcg/L
  • Known valvular heart disease with CHF in the last 6 months
  • Known (or in the investigator's judgment) existence of severe aortic stenosis or mitral stenosis
  • Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months
  • Suspicion of aortic dissection on admission
  • Acute arrhythmia (including any tachy- or bradycardia) with hemodynamic instability on admission (systolic blood pressure < 100 mmHg).
  • 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 or without apparent cause; (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.
  • Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.
  • Prosthetic heart valves
  • Contraindication to MRI (metal implant, etc.)
  • Documented left ventricular ejection fraction < 35%

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

The purpose of this study is to find out what effects, good and bad, the medication Albumin has on subjects who have experienced a type of stroke known as an intracerebral hemorrhage (ICH). An ICH is when spontaneous bleeding into the brain occurs due to fragile blood vessels.

This research is being done because currently there is no effective treatment for ICH. However, study investigators believe that Albumin, the medication being tested in this study, is safe and may help improve patient recovery from ICH over time.

Read more

Subjects will be enrolled in the study for a total of 90 days. Following enrollment, subjects will be randomized to receive 3 daily injections of either Albumin or Placebo (liquid with no drug), and will receive 3 brain MRI scans (with and without contrast), as described below.

All subjects will be monitored continuously through 96 hours after enrollment (5 days) in the Georgetown ICU. Blood tests and clinical evaluations of neurological status, consisting of questions about subjects' functional abilities and medical history, will occur in the Georgetown ICU once every 24 hours through post-enrollment Day 5. Additionally, subjects will receive daily chest x-rays, and daily EKGs (exams that monitor how your heart is doing by placing electrodes, or small monitors, on your skin in specific locations).

Similar clinical evaluations will occur at Day 30 and Day 90. Should subjects be discharged at these time points, day 30 assessments will occur over the phone, and day 90 assessments will occur in-person at Georgetown University Medical Center.

Read the detailed description

We aim to determine the safety and explore the efficacy of human albumin as a neuroprotective (or cytoprotective) agent for the treatment of acute primary supratentorial ICH. Albumin therapy has been shown to be cytoprotective in animal studies of both ischemic stroke and intracerebral hemorrhage, and in a phase II human study in ischemic stroke.

To date no acute intervention (beyond supportive medical care) has been identified to improve outcomes in patients with primary ICH. Neuronal injury from a primary ICH is due not only to the space occupying effects of the hemorrhage but also due to the development of edema and toxicity from blood breakdown products in the subacute phase. Cytoprotective strategies targeted to limit blood brain barrier (BBB) breakdown and edema formation hold promise as treatment strategies to limit this injury.

A number of MR imaging outcome markers demonstrating a potential neuroprotective effect include measures of hematoma volume, perihematomal edema, and blood brain barrier disruption. The term "hyperintense acute injury marker" (HARM) has been proposed to describe the radiologic finding of hyperintense signal within the cerebrospinal fluid spaces visualized on post-contrast fluid attenuated inversion recovery (FLAIR) MRI in patients with acute ischemic stroke. HARM has the potential to serve as a marker of blood brain barrier disruption in patients with primary ICH. The current study will involve serial MR imaging in ICH patients randomized to placebo vs. albumin to assess whether there are differences in the frequency of HARM and perihematomal edema in the albumin treated patients.

Being tested
Albumin, Placebo, Brain MRI with and without contrast
Keywords
Primary ICH, Albumin, MRI, Neuroimaging outcome, Placebo-controlled, Phase II, Blinded, Safety, Acute ICH, ICH, Primary acute (< 48 hours) supratentorial ICH
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlbuminDrug

    Also called BUMINATE 25%, Albumin (Human)

    Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.

  • PlaceboDrug

    Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment

  • Brain MRI with and without contrastProcedure or surgery

    Also called 1.5T Siemens Symphony MRI., 3T Siemens Verio

    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)
Study groups in NCT00990509
Study groupRoleWhat they receive
AlbuminExperimentalNot described
Receives: Drug: Albumin; Procedure: Brain MRI with and without contrast
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo; Procedure: Brain MRI with and without contrast

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Hyperintense Acute injuRy Marker (HARM)

    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.

    Measured: Day 5 MRI

  2. Assessment of Safety of Albumin Administration in Primary ICH

    Serious 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

    Measured: Through Day 90 following enrollment

  3. Mean Intracerebral Hemorrhage (ICH) Volume

    11 of 14 participants received a Day 5 MRI. Mean ICH volume based on 11 participants is presented.

    Measured: Day 5 MRI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJun 2013
  4. Study completionJun 2013

Why it stopped: Enrollment was stopped due to low recruitment and the PI's move to a different institution.

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00990509
Sponsor's protocol ID
2009-173
Acronym
ACHIEVE
Status last verified
Aug 2014
First submitted
1 Oct 2009
Last updated
29 Aug 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Albumin and Brain MRI with and without contrast in people with Intracerebral Hemorrhage, run by Georgetown University 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 4 inclusion and 23 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 29 Aug 2014. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Hyperintense Acute injuRy Marker (HARM) (time frame: Day 5 MRI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00990509.

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 29 Aug 2014.

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