Efficacy of the prophylactic dose of Tranexamic acid on the amount of bleeding in jaw surgeries :a prospective randomized double blind clinical trial study
various techniques are used to achieve the ideal operative field necessary for successful jaw surgeries and decreased bleeding.Controlled hypotension is one way that used to improve surgical conditions during jaw surgery .Tranexamic acid is another way which allow control of intraoperative bleeding and thus might be valuable tool to compare with other techniques .The aim of this study is the compare of the surgical field , intraoperative bleeding in patients in whom Tranexamic acid is used as apposed to placebo.For this reason in a double blind randomized clinical trial 90 patients from 18 to 40 years old,ASA class I or II that scheduled for compound jaw fractures surgery will select (after explaining the process of the trial, written informed consent obtained from participants) .Patients with coagulation disorders ,head injury or drug sensitivity will be excluded from this study .anesthesia technique is similar in both of groups. Then they will divide into two groups randomly, the first group will receive intra venous Tranexamic acid 10 mg/kg , second group normal saline with the same volume and surgical condition and intraoperative bleeding ,post operative hematochrite after 6 hours will be recorded and then analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060115963N2
Registration date:2014-06-29, 1393/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-29, 1393/04/08
Registrant information
Name
Soudabeh Haddadi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13332383068
Email address
so_haddadi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences, Research Vice
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of the prophylactic dose of Tranexamic acid on the amount of bleeding in jaw surgeries :a prospective randomized double blind clinical trial study
Public title
anesthesia technique in jaw surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients candidate for jaw fractures surgery (18-40yr);
ASA c lass I, II
Exclusion criteria:
History of Hemorrhagic Disease; thrombosis; Drugs That affect on the surgical Homeostasis; Anemia (Hematochrite <30);history of head injury ;intra cranial hematoma
; drug sensitivity to Tranexamic acid
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Guilan University of Medical Sciences Research Vice
Street address
Dr Beheshti st.
City
Rasht
Postal code
Approval date
2014-05-05, 1393/02/15
Ethics committee reference number
1930069507
Health conditions studied
1
Description of health condition studied
Dentofacial anomaly, unspecified
ICD-10 code
k07.9
ICD-10 code description
Dentofacial anomaly, unspecified
Primary outcomes
1
Description
the amount of intra operative bleeding
Timepoint
Every 15 minutes
Method of measurement
in the base of the bloody gauzes , amount of blood in suction bottle