Status:
TERMINATED
Albumin for Intracerebral Hemorrhage Intervention
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- Primary supratentorial ICH
- \< 48 hours from symptom onset
- Age \>18
- Signed informed consent obtained from the patient or patient's legally authorized representative
Exclusion
- 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
- 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%
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00990509
Start Date
September 1 2009
End Date
June 1 2013
Last Update
August 29 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007