Albumin for Intracerebral Hemorrhage Intervention

NCT00990509 | Terminated Phase 2 Results

• 1 other identifier: 2009-173
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Intracerebral Hemorrhage

Keywords

Primary ICH; Albumin; MRI; Neuroimaging outcome; Placebo-controlled; Phase II; Blinded; Safety; Acute ICH; ICH; Primary acute (< 48 hours) supratentorial ICH

Outcome Measures

Primary Outcomes (3)

• 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.

  Day 5 MRI

• 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

  Through Day 90 following enrollment

• Mean Intracerebral Hemorrhage (ICH) Volume

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

  Day 5 MRI

Study Arms (2)

Albumin

EXPERIMENTAL

Drug: Albumin; Procedure: Brain MRI with and without contrast

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Procedure: Brain MRI with and without contrast

Interventions

Albumin DRUG

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

Also known as: BUMINATE 25%, Albumin (Human)

Albumin

Placebo DRUG

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

Placebo

Brain MRI with and without contrast PROCEDURE

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)

Also known as: 1.5T Siemens Symphony MRI., 3T Siemens Verio

Albumin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Georgetown University: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Albumins; Contrast Media

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Limitations and Caveats

There was an insufficient number of subjects in each treatment arm to allow for a meaningful analysis of the effects of albumin on HARM status (blood brain barrier disruption).

Results Point of Contact

• Title: Chelsea Kidwell, MD
• Organization: University of Arizona

ckidwell@neurology.arizona.edu

(520) 626-7159

Study Officials

• Chelsea Kidwell, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology; Medical Director, Georgetown University Stroke Center

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 7, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 29, 2014
• Results First Posted: August 29, 2014

Record last verified: 2014-08

Locations

US (1)