Assessment of the effect of Albumin compared with Placebo on the reduction of the hematoma volume in patients with Hemorrhagic Stroke referred to Ahvaz Golestan Hospital
(1) Objectives : Assessment of the effect of Albumin on the reduction of the hematoma volume in patients with Hemorrhagic Stroke.
(2) Design : Randomized, Double-blind, Placebo-controlled, Single central, Phase 2 trial.
(3) Setting and conduct : Patients with Hemorrhac Stroke in the last 24 hours of onset are randomly allocated in two groups; The case group is received Albumin form vials of human Albumin 20% and the control group is recived saline 0.9% as Placebo. The hematoma volume is calculated on CT scan befor and at the end of intervention (After one week). The results is compared between groups. In addition, the neurological deficits are estimated by NIHSS criteria befor intervention and one month later then results is compared between groups.
(4) Participants including major eligibility criteria : 60 patients. Major inclusion criteria : Primary Hemorrhagic Stroke; 24 hours from symptom onset; above 18 years old. Major exclusion criteria : Need surgical evacuation; Allergy to Albumin; Severe cardiac or renal failure.
(5) Intervention : 1- Vials of human Albumin 20% 1 g/kg divided in 7 days within daily IV infusion during 2 hours in case group; 2- Saline 0.9% (with an equal volume of 1 gr/kg from human Albumin 20% vial) in 7 days within 2 hours IV infusion as Placebo in control group.
(6) main outcome measures (variables) : 1- The hematoma volume; 2- The neurological deficits.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201018574N1
Registration date:2013-02-13, 1391/11/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-13, 1391/11/25
Registrant information
Name
Davood Shalilahmadi
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
shalilahmadi.d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Albumin compared with Placebo on the reduction of the hematoma volume in patients with Hemorrhagic Stroke referred to Ahvaz Golestan Hospital
Public title
Effect of Albumin on size of hematoma in Hemorrhagic Stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria : Primary Hemorrhagic Stroke; 24 hours from symptom onset; Above 18 years old.
Exclusion Criteria : Hematoma volume less than 7 ml; Need surgical evacuation; Pregnancy; Lactation; Systolic blood pressure less than 100 mmHg or more than 250 mmHg; Anticoagulant or Thrombolytic therapy; Serum Creatinine more than 2 mg/dl; History of known allergy to Albumin; History of severe allergic reactions known as latex gloves; Exacerbation of congestive heart failure within the past 6 months; Acute myocardial infarction in the last 6 months.
Age
From 18 years old to 149 years old
Gender
Both
Phase
2
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
61357-15794
Approval date
2011-08-26, 1390/06/04
Ethics committee reference number
ETH-203
Health conditions studied
1
Description of health condition studied
Hemorrhagic Stroke
ICD-10 code
I61.9
ICD-10 code description
Intracerebral Haemorrhage, Unspecified
Primary outcomes
1
Description
The hematoma volume
Timepoint
Befor intervention, The end of intervention (One week)
Method of measurement
The hematoma volume on CT scan (ml) : Length of maximum appearance of hematoma (cm) × Width of same cut (cm) × Number of cuts including bleeding / 2
Secondary outcomes
1
Description
Neurological deficits
Timepoint
Befor intervention, After one month
Method of measurement
NIHSS criteria
Intervention groups
1
Description
Vials of human Albumin 20% : 1 gram per kiloogram body weight divided in 7 days within daily IV infusion during 2 hours
Category
Treatment - Drugs
2
Description
Saline 0.9% (with an equal volume of 1 gr/kg from human Albumin 20% vial) in 7 days within 2 hours IV infusion
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Davood Shalilahmadi, MD
Street address
Nosrat St, Golestan Blv.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Feghhi, MD
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Davood Shalilahmadi, MD
Position
Resident of Neurology
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
shalilahmadi.d@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Seyed Ehsan Mohamadianinejad, MD
Position
Professor Assistant
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
shalilahmadi.d@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Davood Shalilahmadi, MD
Position
Resident of Neurology
Other areas of specialty/work
Street address
Esfand St, Golestan Blv.
City
Ahvaz
Postal code
Phone
+98 61 1374 3012
Fax
Email
shalilahmadi.d@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)