The effect of intravenous Tranexamic acid on blood loss and the quality of surgical field during endoscopic sinus surgery: A placebo-controlled clinical trial
Objectives: To evaluate the effect of intravenous tranexamic acid on blood loss and the quality of surgical field in functional endoscopic sinus surgery.
Methods: In a placebo-controlled clinical trial a total of 84 ASA physical status I-II patients, aged 19–64 years, undergoing endoscopic sinus surgery for chronic sinusitis were randomly allocated to receive either intravenous TA 10 mg/kg or sterile water 0.1cc/kg as a bolus dose immediately after induction of anesthesia. Anesthesia and surgery protocols were the same in both groups. The amount of blood loss as well as bleeding and satisfaction scores obtained from the surgeon were measured and compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010265026N1
Registration date:2011-02-21, 1389/12/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-21, 1389/12/02
Registrant information
Name
Masood Mohseni
Name of organization / entity
Rasul Akram hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
mohseni@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancelleer for research, Tehran University of Medical Sciences
Expected recruitment start date
2009-04-01, 1388/01/12
Expected recruitment end date
2010-10-30, 1389/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous Tranexamic acid on blood loss and the quality of surgical field during endoscopic sinus surgery: A placebo-controlled clinical trial
Public title
The effect of intravenous Tranexamic acid on blood loss and the quality of surgical field during endoscopic sinus surgery
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion: ASA physical status I-II patients candidate of endoscopic sinus surgery for chronic sinusitis
Exclusion: Patients receiving anticoagulants or having a bleeding diathesis
Age
From 19 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
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 Tehran University of Medical Sciences
Street address
Hemmat Blv
City
Tehran
Postal code
Approval date
2009-05-24, 1388/03/03
Ethics committee reference number
861 پ
Health conditions studied
1
Description of health condition studied
Haemorrhagic condition
ICD-10 code
D69.9
ICD-10 code description
Haemorrhagic condition, unspecified
Primary outcomes
1
Description
The quality of surgical field
Timepoint
at the end of surgery
Method of measurement
Standardized scale
2
Description
Blood loss
Timepoint
at the end of surgery
Method of measurement
visual estimation of blood loss in bottles
Secondary outcomes
1
Description
blood presssure, heart rate
Timepoint
q 15 minutes
Method of measurement
data collected from standard operting room monitoring systems
Intervention groups
1
Description
intravenous tranexamic acid (10 mg/kg as a bolus dose immediately after induction of anesthesia)
Category
Treatment - Drugs
2
Description
Placebo (sterile water 0.1cc/kg as a bolus dose immediately after induction of anesthesia)
Category
Placebo
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
Vice chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Younesian
Street address
N 601, 6th floor, Tehran University of Medical Sciences, Ghods Ave, Keshavarz Blv
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, 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
Department of Anesthesiology, Tehran University of Medical Sciences
Full name of responsible person
Mahzad Alimian
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Rasul Akram Hospital
City
Tehran
Postal code
Phone
+98 216432326
Fax
Email
Alimian.mahzad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahzad Alimian
Position
assistant professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Rasul Akram hospital
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
alimian.mahzad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
masood.mohseni@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)