Evaluation of The Effect of The Tranexamic Acid and Placebo on The Amount of Bleeding in Patients Under Surgical Treatment of Bilateral Mandibular Fractures
This study is a prospective and randomized double-blind clinical trial. The aim of this study is evaluation of the effect of the tranexamic acid on the amount of bleeding in patients under surgical treatment of bilateral mandibular fractures. Total of sample size is 36 patients with ages: 20-40 years old. Patients with bilateral mandibular fractures are candidates for inclusion. The patients with unilateral mandibular fractures and cheekbone and maxillary fractures with subarachnoid hemorrhage will be excluded. The patients are randomly divided into two groups. The patients do not know what do they have received and evaluation of patients is performed by person who does not know about the protocol of the study. First group receives 20 ml of tranexamic acid (20mg/kg) before surgery. Second group receives 20 ml of normal saline solution (0.9%) before surgery. The amount of hemoglobin and hematocrit levels in patients is recorded before and after surgery in both groups by sampling blood. The amount of blood loss is calculated with subtracting preoperative and postoperative hemoglobin and hematocrit levels in blood. Patients do not use any medications before surgery. The temperature and the amount of body fluids can be controlled precisely by the anesthesiologist. All of patients undergoing surgery will be placed in the supine position (15 °).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051122204N1
Registration date:2015-06-10, 1394/03/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-10, 1394/03/20
Registrant information
Name
Majid Ahmadfar
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6504
Email address
ahmadfar.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
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 of The Effect of The Tranexamic Acid and Placebo on The Amount of Bleeding in Patients Under Surgical Treatment of Bilateral Mandibular Fractures
Public title
The Effect of The Tranexamic Acid on The Amount of Bleeding In Patients Under Surgical Mandibular Fractures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Patients undergoing bilateral mandibular fractures surgery. Exclusion Criteria: Patients with subarachnoid hemorrhage; History of CVA (cerebrovascular accident definition); History of thrombosis; History of renal diseases and hematuria; Patients with bone disease; Patients with cleft lip and palate; Patients with craniofacial syndromes; History of Temporomandibular joint surgery; History of bone transplant recipient.
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The table of random numbers used for randomization, A code will be assigned to each patient by a person who does not know about the protocol of the study. Blood volume (BV)= 70 ml/kg for men and Blood volume (BV)= 65 ml/kg for women. CBL= Calculated blood loss
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2014-10-04, 1393/07/12
Ethics committee reference number
ajums.REC.1393.213
Health conditions studied
1
Description of health condition studied
Intraoperative bleeding
ICD-10 code
Y60
ICD-10 code description
Unintentional cut, puncture, perforation or haemorrhage during surgical and medical care
Primary outcomes
1
Description
The amount of hemoglobin
Timepoint
Immediately before surgery and immediately after surgery
Method of measurement
Venous sampling and sent to the laboratory
2
Description
The amount of hematocrit
Timepoint
Immediately before surgery and immediately after surgery
Method of measurement
Venous sampling and sent to the laboratory
Secondary outcomes
1
Description
Bleeding (By calculating the difference between pre- and postoperative hemoglobin(Hb))
Timepoint
After surgery
Method of measurement
Using the formula: CBL= BV×(Hb loss/Hb per), Hb loss = Hb pre – Hb post + t(The number of injected packed red blood cell units)
2
Description
Bleeding (By calculating the difference between pre- and postoperative hematocrit(Hct))
Timepoint
After surgery
Method of measurement
Using the formula: CBL = RBCL / [(HCTper+HCTpost)/2], RBCL = BV × (Hct pre – Hct post) + 320 t
Intervention groups
1
Description
Group I: injection of 20 ml of tranexamic acid (20 mg/kg), precisely before surgery
Category
Prevention
2
Description
Group II: injection of 20 ml of normal salin solution (0.9%), precisely before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohamadreza Gousheh
Street address
Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
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 Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Majid Ahmadfar
Position
Resident Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
majid.ahmadfar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Kazem Khiabani
Position
maxillofacial surgeon
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
khiabani_k@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pain Research Center
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Pain Research Center, Fourth Floor of Imam Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
s.nz1990@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)