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Effect of Albumin in Hemorrhagic Stroke

The effect of intravenous albumin in mortality and morbidity of intracranial hemorrhage; a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201111288240N1
Enrollment
60
Registered
2012-06-05
Start date
2011-04-04
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemoragic Stroke. Intracerebral haemorrhage in hemisphere, unspecified

Interventions

Intervention 1: 20% Vial Human Albumin with total dosage of 1 gram per kilogram Body Weight infusion during 7 days within 2 hours daily. Intervention 2: Plasebo Vial as the Same Dose of Albumin.
Treatment - Drugs
Placebo
20% Vial Human Albumin with total dosage of 1 gram per kilogram Body Weight infusion during 7 days within 2 hours daily
Plasebo Vial as the Same Dose of Albumin

Sponsors

JondiShapur Ahvaz university of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 83 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1.Primary supratentorial ICH; 2.18. Exclusion Criteria: 1.ICH volume 200 mmHg); 7.Current participation in another experimental treatment protocol; 8.Renal impairment with GFR 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 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%.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Patient Functional Outcome. Timepoint: At admission time, after one week and after 3 months. Method of measurement: NIHSS.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMorteza Oghbaei, MD

JondiShapurAhvaz University of Medical Sciences

mortezaoghbaee@yahoo.com+98 61 1374 3012

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026