The study aims: to reduce bleeding in major surgery.It is a blind study. Study of population: 60 orthopedic patients who need to have this surgery and are elective . Inclusion criteria for femoral shaft fractures are first time, non-emergency, aged 60-18 years and exclusion criteria are prohibition tranexamic acid and hypotension. In the first group of controlled hypotension using nitroglycerin during anesthesia and mean arterial pressure of 60 mmHg and 90-80 mmHg for systolic pressure is brought and in the second group that are normotensive, half hour before and after the anesthetic tranexamic acid is injected and Systolic arterial blood pressure is maintained in the range 130-120 and outside of this measures the medical therapy is performed and the patient is excluded of this study. All the patients are under general anesthesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111198131N1
Registration date:2012-02-27, 1390/12/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-27, 1390/12/08
Registrant information
Name
Majid Abdaviazar Sharabiani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7704 2205
Email address
abdaviazarmajid@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for reseach, Tehran University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-10-22, 1390/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of femoral shaft fracture bleeding in the two methods of Tranexamic acid and controled hypotension
Public title
Tranexamic acid in reducing bleeding in the femoral shaft fracture surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: femoral shaft fracture; the first time; non-emergency; age 60-18 years; Normotensive being; tourniquet is not used; the amount of Hgb in the range of 12-10; following a period of 3 hours. Exclusion criteria: prohibition hypotension (eg, cardiovascular disease ); previous use of anticoagulants; unexpected factors that complicate or prolong the surgery; to be with multiple trauma; hypertensive patients; reintroduction; diseases that cause clotting disorders; including banning the use of tranexamic acid.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Pursina street, 16 Azar street
City
Tehran
Postal code
Approval date
2010-04-13, 1389/01/24
Ethics committee reference number
42112
Health conditions studied
1
Description of health condition studied
Fracture of shaft of femur
ICD-10 code
S72.3
ICD-10 code description
Fracture of shaft of femur
Primary outcomes
1
Description
The amount of bleeding
Timepoint
during anesthesia
Method of measurement
Counting blood gases, the suction,and operation field
Secondary outcomes
1
Description
Hypotension
Timepoint
during anesthesia
Method of measurement
by NIBP
2
Description
arhythmia
Timepoint
during anesthesia
Method of measurement
by monitoring of ECG
3
Description
sever bleeding
Timepoint
during anesthesia
Method of measurement
The number of blood gas , Surgery field,suction
Intervention groups
1
Description
tranexamic acid injection
500 mg
Two Time
Category
Treatment - Drugs
2
Description
TNG injection
5 Mic per min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul Akram hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice chancellor for reseach, Dr Akbar Fotuhi
Street address
Central organization of Tehran University of Medical Sciences, Gods street, Keshavarz street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Majid Abdaviazar Sharabiani
Position
Resident of anesthesia
Other areas of specialty/work
Street address
Anesthesia group, Rasul Akram hospital, Niayesh street, Satarkhan street
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
abdaviazarmajid@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Valiollah Hassani
Position
Professor
Other areas of specialty/work
Street address
Group of anesthesia; Rasul akram hospital; Niayesh street; Satarkhan street
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
vhassani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Majid Abdaviazar Sharabiani
Position
Resident of anesthesia
Other areas of specialty/work
Street address
Group of anesthesia, Rasul Akram hospital, Niayesh street, Satarkhan street
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)