Effect of Albumin in Hemorrhagic Stroke
- Conditions
- hemoragic Stroke.Intracerebral haemorrhage in hemisphere, unspecified
- Registration Number
- IRCT201111288240N1
- Lead Sponsor
- JondiShapur Ahvaz university of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria: 1.Primary supratentorial ICH; 2.< 24 hours from symptom onset; 3.Age >18.
1.ICH volume < 7 cc; 2.Glasgow Coma Scale < 8; 3.Surgical evacuation anticipated; 4.Pregnancy; 5. Breastfeeding; 6.Hemodynamic instability (SBP < 100 mmHg, > 200 mmHg); 7.Current participation in another experimental treatment protocol; 8.Renal impairment with GFR < 30 or Creatinine > 2.0; 9.History of or known allergy to albumin; 10. History of or known severe allergy to rubber latex; 11.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); 12.Acute myocardial infarction in the last 6 months; 13.Elevated serum troponin level on admission > 0.1 mcg/L; 14.Known valvular heart disease with CHF in the last 6 months; 15.Known (or in the investigator's judgment) existence of severe aortic stenosis or mitral stenosis; 16.Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months; 17.Suspicion of aortic dissection on admission; 18.Acute arrhythmia (including any tachy- or bradycardia) with hemodynamic instability on admission (systolic blood pressure < 100 mmHg); 19.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; 20.Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy; 21.Prosthetic heart valves; 22.Documented left ventricular ejection fraction < 35%.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient Functional Outcome. Timepoint: At admission time, after one week and after 3 months. Method of measurement: NIHSS.
- Secondary Outcome Measures
Name Time Method Morbidity and Mortality. Timepoint: At the admision, after one week and 3 month. Method of measurement: Registration of mortality.;Drug side effects. Timepoint: At the admision, after one week and 3 months. Method of measurement: Drug side effects chart.