Comparative Study Of Number Of Allogenic Blood Transfusion In Normovolemic Hemodilution Auto transfusion Versus Routine Method in open surgery of femor
Purpose:
Comparison of number of bank blood transfusion in autologous versus Allogenic blood transfusion with normovolemic hemodilution
Patients who scheduled for elective open surgery of femur selected. Patients with hemoglobin less than 11 g/100; ASA more than 3; with coagulation disorder and who refuse to participate in study excluded. 50 patients selected and randomly allocated in two equal groups. In case group we took 450 cc bloods and simultaneously we injected three fold lactated ringer from other vain and stored blood in special bank blood bag. In case group if needed first infused autologous blood and if needed more we used allogenic blood. In control group if needed we used allogenic blood.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012045313N1
Registration date:2012-03-25, 1391/01/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-25, 1391/01/06
Registrant information
Name
Ebrahim Khoshraftar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1824 1334
Email address
khoshraftar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research And Technology; Hamedan University Of Medical Sciences
Expected recruitment start date
2008-04-03, 1387/01/15
Expected recruitment end date
2011-11-21, 1390/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study Of Number Of Allogenic Blood Transfusion In Normovolemic Hemodilution Auto transfusion Versus Routine Method in open surgery of femor
Public title
Comparison Of Allogenic Blood Transfusion Versus Routine Blood Transfusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with open femoral fracture who schedule for surgery, ASA less than 3, hemoglobin more than 11
Exclusion criteria were Cardiac disease, impaired renal function, baseline hemoglobin <11 g/dl, low concentrations of coagulation proteins, inadequate vascular access, and the absence of appropriate monitoring capability and refusal of participating in study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University Of Medical Sciences
Street address
In Front Of Mardom Par; Hamedan
City
Hamedan
Postal code
Approval date
2007-01-07, 1385/10/17
Ethics committee reference number
16/35/2455/پ
Health conditions studied
1
Description of health condition studied
Blood Transfusion
ICD-10 code
Z51.3
ICD-10 code description
Blood Transfusion (without reported diagnosis)
Primary outcomes
1
Description
need to blood transfusion
Timepoint
perioperative
Method of measurement
bloody gasses and suction blood
Secondary outcomes
1
Description
PT
Timepoint
before anesthesia
Method of measurement
laboratory tests
2
Description
PT
Timepoint
after anesthesia
Method of measurement
laboratory tests
3
Description
Hb
Timepoint
before anesthesia
Method of measurement
laboratory tests
4
Description
Hb
Timepoint
after anesthesia
Method of measurement
laboratory tests
5
Description
platelet
Timepoint
before anesthesia
Method of measurement
laboratory tests
6
Description
platelet
Timepoint
after anesthesia
Method of measurement
laboratory tests
Intervention groups
1
Description
injection of maintenance serum, induction of anesthesia, assessment of blood loss, injection of bank blood if needed in control group
Category
Treatment - Other
2
Description
injection of maintenance serum, 450 cc blood sampling, injection of ringer three fold, induction of anesthesia, assessment of blood loss, injection of patients blood first if needed, injection of bank blood if patients needed more blood in case group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital; Hamedan
Full name of responsible person
Bakhshai; Mohammad Hossein; Dr
Street address
Operating Room; Besat Hospital; Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research And Technology
Full name of responsible person
Vice Chancellor For Research And Technology
Street address
Vice Chancellor For Research And Technology- Hamedan University Of Medical Sciences
City
Hamedan
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 And Technology
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
Hamedan University Of Medical Sciences
Full name of responsible person
Dr.Mohammad Hossein Bakhshai
Position
Associated Professor
Other areas of specialty/work
Street address
Operating Room; Besat Hospital
City
Hamedan
Postal code
Phone
+98 81 1264 0051
Fax
Email
Bakhshai@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University Of Medical Sciences
Full name of responsible person
DR. Ebrahim Khoshraftar
Position
Associated Professor
Other areas of specialty/work
Street address
Operating Room; Besat Hospital
City
Hamedan
Postal code
Phone
+98 81 1824 1334
Fax
Email
Khoshraftar@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)