The effect of tranexamic acid in reducing of bleeding during and after spinal fixation surgery is the aim of this study. the study is a double blind clinical trial with placebo group. the Population of this study are the patients aged 18 to 60 years old with ASA class 1 and 2 admitted for spinal fixation surgery. patients with history of thromboemboly and vascular disease and consumption of anticoagulant drugs have been excluded from study. 102 patients evaluated in 3 groups. for the first and second group 10 mg\kg tranexamic acid as bolus dose of drug is infused before skin incision. for the second group maintenance dose of tranexamic acid 1 mg/kg/hour continued during surgery. for the third group normal saline as a placebo is infused. this is expected that the amount of bleeding during surgery by fallowing administration of tranexamic acid will be reduced and this reduction will be more in patients who have recieved maintenance infusion of tranexamic acid . thus blood transfusion to patients and complications of transfusion are prevented.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101924601N1
Registration date:2015-11-29, 1394/09/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-29, 1394/09/08
Registrant information
Name
Mirhossein Mousavi Yengejeh
Name of organization / entity
Aardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 2520
Email address
mh.mousavi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Ardabil University of Medical Sciences
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two doses of tranexamic acid on reducing of bleeding during spinal fusion surgery
Public title
The effect of tranexamic acid on reducing of bleeding during spinal fixation surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patients aged beetween 18 and 60 years old with class ASA 1 and 2 (american anesthesia society) that admitted for spinal fixation surgery.
Exclusion criteria: the patient's Dissatisfaction.the patients with thrombotic diseases. the use of antithrombotic drugs. history of cardiovascular and cerebral disease. hypertention. deep vein thrombosis. pulmonary emboli. peripheral vascular disease. pregnant and lactating women and history of allergy to tranexamic acid
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
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 Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Shool of Medicine, Daneshgah Street
City
Ardabil
Postal code
5618953141
Approval date
2015-10-04, 1394/07/12
Ethics committee reference number
IR.ARUMS.REC.1394.51
Health conditions studied
1
Description of health condition studied
The effect of two different form Tranexamic Acid administration for bleeding reduction at spinal fixation surgery
ICD-10 code
D69.9
ICD-10 code description
Haemorrhagic condition, unspecified
Primary outcomes
1
Description
The volume of bleeding due to surgery
Timepoint
The end of surgery and 24 hours later
Method of measurement
The volume of blood in suction after reducing washing serum and scale of bloody guases by digital scale
2
Description
the volume of blood transfused to patient
Timepoint
at the surgery time untill 24 hours later
Method of measurement
the amount of pack cell transfused
Secondary outcomes
1
Description
Hemodynamic variation
Timepoint
Before anesthesia and then every 30 minuets
Method of measurement
Noninvasive digital blood pressure monitor and pulseoximetry
2
Description
Complication due to drug(nausea. vomitting. abdominal pain. skin reactions. DVT. pulmonary emboli. CAD. CVA)
Timepoint
The end of surgery in recovery and 24 hours later in hospitalization wards
Method of measurement
Visit and interview with patients
3
Description
Surgery duration
Timepoint
From incison of skin till end of skin suture
Method of measurement
To minute
Intervention groups
1
Description
Infusion 10 mg/kg of tranexamic acid by microset with total volume of 100 cc during 10 minutes before skin incision and continued with 20 drop/ min of normal saline as placebo
Category
Treatment - Drugs
2
Description
Infusion 10 mg/kg of tranexamic acid by microset with total volume of 100 cc during 10 minutes before skin incision and continued by 1 mg/kg/hour drug infusion untill end of surgery
Category
Treatment - Drugs
3
Description
control group: infusion of 100 cc normal saline during 10 minutes and continued infusion with 20 drop/min untill end of suegery as placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital
Full name of responsible person
Ali Mohammadian Erdi, Associate Professor of Anesthesia
Street address
Fatemi Hospital, Shariati Square, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Ardabil University of Medical Sciences
Full name of responsible person
Akbar Pirzadeh
Street address
Ardabil University of Medical Sciences, Shool of Medicine, Daneshgah Street
City
Ardabil
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 of Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Ali Mohammadian Erdi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Fatemi Hospital, Shariaty Square, Ardabil
City
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
+98 45 3323 2670
Email
A.mohammadian@arums.ac.ir
Web page address
www.medicine.arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Mohammadian Erdi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Fatemi Hospital, Shariati Square,Adabil
City
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
+98 45 3323 2670
Email
A.mohammadian@arums.ac.ir
Web page address
www.medicine.arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Siences
Full name of responsible person
Ali Mohammadian Erdi
Position
Associate professor of Anesthesia
Other areas of specialty/work
Street address
Fatemi Hospital, Shariaty Square, Ardabil
City
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
+98 45 3323 2670
Email
A.mahammadian@arums.ac.ir
Web page address
www.medicine.arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)