evaluation the effect of recombinant erythropiotin on Haft -e- Tir & Sina hospitals' multiple trauma patients' need to recurrrent blood transfusion & noninvasive hemodynamic & laboratory parameters
The goal of research is the evaluation of the effect of recombinant erythropoitin on recurrent blood transfusion -noninvasive hemodynamic & laboratory parameters in multiple trauma patients. Inclusion criterias are blood transfusion within 24 hour of enterance of patient to the hospitals ,patiant age more than 18years,agreement of the patient , & having no other disease.Exclusion criterias are disagreement , and death of patient.Target sample size is 60 patients.The intervention is transfusion of 300u/kg erythropoitin intavenous together with blood transfusion within the first 24 hours of enterance of patients to the hospitals with aim to decrease the needs to recurrent blood transfusion & improvement of vital signs & laboratory parameters:Hpcidine & Micro-albumine to creatinin ratio
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014100617891N4
Registration date:2014-12-09, 1393/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-09, 1393/09/18
Registrant information
Name
Nader Tavakoli
Name of organization / entity
Iran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8891 5410
Email address
tavakoli.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor of Research of Iran Medical University
Expected recruitment start date
2014-12-06, 1393/09/15
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation the effect of recombinant erythropiotin on Haft -e- Tir & Sina hospitals' multiple trauma patients' need to recurrrent blood transfusion & noninvasive hemodynamic & laboratory parameters
Public title
evaluation the effect of erythropoitin on multiple trauma patients that need blood transfusion
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:being Multiple Trauma, age more than18 years, blood transfusion within 24 hours of enterance to the hospital, consiouss agreement of the patient (if has ability to decide & is completely alert) or his legal attendant/ deputy(in other situations),no affection to other diseases
exclusion criteria: consiouss disagreement of the patient or his legal attendant/ deputy during the research,death of patient within first three days of hospital admission
Age
From 18 years old
Gender
Both
Phase
N/A
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
vice chanceller for research of Tehran medical science university
Street address
Keshavarz Boulevard corner of Ghods bystreet central organization of Tehran medical science university 6th floor
City
Tehran
Postal code
1417653761
Approval date
2014-09-28, 1393/07/06
Ethics committee reference number
1640 /130 /د /93
Health conditions studied
1
Description of health condition studied
blood transfusion in multiple trauma patient
ICD-10 code
T79.2
ICD-10 code description
Traumatic secondary and recurrent haemorrhage
Primary outcomes
1
Description
blood transfusion volume to the patient
Timepoint
end of patient admission at the hospital
Method of measurement
number of pack cells with counting the documented transfused pack cells in patients' files
2
Description
blood pressure
Timepoint
at the begining & third day of trial
Method of measurement
mm Hg with using mercury sphingomanometer set
3
Description
heart beats
Timepoint
at the begining & third day of trial
Method of measurement
number of heart beats per minute with using heart monitoring set
4
Description
blood oxygen saturation
Timepoint
at the begining & third day of trial
Method of measurement
percent of blood oxygen saturation with using pulse oximeter set
5
Description
respiratory rate
Timepoint
at the begining & third day of trial
Method of measurement
number of patient's breath per minute with physical examination
6
Description
plasma hepcidin
Timepoint
third day of trial
Method of measurement
nanogram per mililiter with using elisa technique
7
Description
urine microalbumine to creatinine ratio
Timepoint
third day of trial
Method of measurement
miligram on milimoll with using radiimmunoassay & Jaffe techniques respectively
Secondary outcomes
1
Description
stay lenghth of patient in hospital
Timepoint
end of patient's admission in hospital
Method of measurement
number of admission days of patient in hospital with using formula discharge date minus admission date plus one
2
Description
patiant's hotelling price in hospital
Timepoint
end of patient's admission in hospital
Method of measurement
price documented in patiant's echonomic file in Rials
Intervention groups
1
Description
Intra venous transfusion of recombinant erythropoitin as 300 unit per Kg of patiant's weight in two minutes duration slowly under cardiac & respiratory monitoring in intervention group as a single dose together with blood transfusion in first day of hospital admission of patiant in hospital
Category
Treatment - Drugs
2
Description
would not be done in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Haftom -e-Tir Shahre Ray
Full name of responsible person
Ali Mannani
Street address
south Shahid Rajaee Highway
City
Tehran
2
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Ali Mannani
Street address
Hasan Abad square , Emam Khomeini street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Chamran Highway , enterance of Hemmat Highway , besides the Milad tower , Iran University of Medical Science
City
Tehran
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
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
Iran University of Medical Science
Full name of responsible person
Ali Mannani
Position
resident of emergency medicine
Other areas of specialty/work
Street address
Shohadaye Haftom -e- Tir hospital , Emergency ward
City
Tehran
Postal code
1886718136
Phone
+98 21 6653 3686
Fax
+98 21 6653 3686
Email
alimannani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Nader Tavakoli
Position
assistance professor
Other areas of specialty/work
Street address
Sattar khan Avenue , Niayesh street , Hazrate rasool hospital
City
Tehran
Postal code
14455-364
Phone
+98 21 6651 7341
Fax
+98 21 6651 7118
Email
tavakoli.n@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran Univesity of Medical Science
Full name of responsible person
Ali Mannani
Position
resident of emergency medicine
Other areas of specialty/work
Street address
south Shahid Rajaei highway , Shohadaye Haftom -e- Tir hospital , Emergency Ward
City
Tehran
Postal code
1886718136
Phone
+98 21 6653 3686
Fax
+98 21 6653 3686
Email
alimannani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)