The aim of this study was to evaluate the effect of Albumin on hemorrhagic stroke. Through a double blind randomized clinical trial, 60 stroke patients were randomly allocated in two groups. The control group received placebo while the intervention group received Albumin (1 g/kg/7days within 2 hours at any time; dosage form: 50 cc vial of human albumin 20%).Functional outcome were recorded according to NIHS scales before treatment and at end of the first week and the end of the third month . The results compared between groups.
General information
Acronym
ACHIEVE
IRCT registration information
IRCT registration number:IRCT201111288240N1
Registration date:2012-06-05, 1391/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-05, 1391/03/16
Registrant information
Name
Morteza Oghbaei
Name of organization / entity
JondiShapur Ahvaz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
oghbaei.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
governmental
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2011-09-06, 1390/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous albumin in mortality and morbidity of intracranial hemorrhage; a randomized clinical trial
Public title
Effect of Albumin in Hemorrhagic Stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1.Primary supratentorial ICH; 2.< 24 hours from symptom onset; 3.Age >18. Exclusion Criteria: 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%.
Age
From 18 years old to 83 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
JondiShapour Ahvaz University of Medical Sciences
Street address
JondiShapour Ahvaz University of Medical Sciences, Golestan
City
Ahvaz
Postal code
Approval date
2011-03-04, 1389/12/13
Ethics committee reference number
408/د
Health conditions studied
1
Description of health condition studied
hemoragic Stroke
ICD-10 code
I61.2
ICD-10 code description
Intracerebral haemorrhage in hemisphere, unspecified
Primary outcomes
1
Description
Patient Functional Outcome
Timepoint
At admission time, after one week and after 3 months
Method of measurement
NIHSS
Secondary outcomes
1
Description
Morbidity and Mortality
Timepoint
At the admision, after one week and 3 month
Method of measurement
Registration of mortality
2
Description
Drug side effects
Timepoint
At the admision, after one week and 3 months
Method of measurement
Drug side effects chart
Intervention groups
1
Description
20% Vial Human Albumin with total dosage of 1 gram per kilogram Body Weight infusion during 7 days within 2 hours daily
Category
Treatment - Drugs
2
Description
Plasebo Vial as the Same Dose of Albumin
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Morteza Oghbaei, MD
Street address
Neurology Department, Golestan Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
JondiShapur Ahvaz university of Medical Sciences
Full name of responsible person
Mehdi Norouzi, MD
Street address
JondiShapur Ahvaz university of Medical Sciences, Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
JondiShapur Ahvaz university of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
JondiShapurAhvaz University of Medical Sciences
Full name of responsible person
Morteza Oghbaei, MD
Position
Resident of Neurology
Other areas of specialty/work
Street address
JondiShapurAhvaz University of Medical Sciences, Golestan
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
mortezaoghbaee@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
JondiShapurAhvaz University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mohammadianinejad, MD
Position
Asistant of professor
Other areas of specialty/work
Street address
JondiShapurAhvaz University of Medical Sciences, Golestan
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
mortezaoghbaee@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
JondiShapur Ahvaz University of Medical Sciences
Full name of responsible person
Morteza Oghbaei, MD
Position
Neurology Resident
Other areas of specialty/work
Street address
JondiShapur Ahvaz University of Medical Sciences, Golestan
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
mortezaoghbaee@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)