1-major objective: The comparison of 2 method of tranexamic acid administration on bleeding after TOTAL HIP ARTHROPLASTY surgery.
2-Design:This study will perform after ethical committee agreement of Guilan University of Medical Sciences and based on a double blind randomized clinical trial study .
3- Setting and Conduct: The patients divided in 2 groups Based on randomization block. In intravenous tranexamic acid group (15mg/kg), transamine will administer by anesthesiologist and based on body weight in a time of 10 minute. Each vial consists of 500mg of tranexamic acid in 5 ml. In tranexamic topical group,patients will recieve 3gr of tranexamic acid(6 vials) that diluted with normal saline intraoperatively by orthoped.After rimming of acetabulom 30 ml of above solution inserted in acetabulom and wound and keeping there about 1 minute. After broaching the femoral canal 30 ml of topical tranexamic acid inserted and keeping there about 1 min. the remain solution (30 ml )insert in the wound after hip joint reduction and will repaired.
4- Participants: All patients who will undergoing total hip arthroplasty surgery, ranging in age from 50-20 years old, ASA (American Society of Anesthesia) I-II, having HB≥ 10gr dl before surgery and not receiving transfusion before surgery.
5-Intervention:The comparison of 2 method of topical tranexamic acid or intravenous tranexamic acid administration on bleeding after surgery.
6-Main Outcome:The study of intraoperative and postoperative bleeding after total hip arthroplasty surgery and need to blood transfusion as secondary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509056280N8
Registration date:2015-10-24, 1394/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-24, 1394/08/02
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3211 1319
Email address
mohaghighi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research OF Guilan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of intravenous tranexamic acid and topical tranexamic acid efficacy on postoperative bleeding after total hip arthroplasty surgery.
Public title
the use of topical tranexamic acid in total hip arthroplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients who undergoing total hip arthroplasty surgery; 50-20 years old; ASA (American Society of Anesthesia) I-II; having HB≥ 10gr dl before surgery ; not receiving transfusion before surgery.
The exclusion criteria:
Emergency surgery; Hb<10mg/dl; The evidence for any condition of IHD or treatment; The evidence for hemorrhagic CVA ; SAH OR STROK; The evidence for TBI; Use of anticoagulant drug; any history of renal ; liver and anemia before operation; History of OCP consumption.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethical Comeetee of Guilan University of Medical Sciences
Street address
Namjoo Avenue, Deputy department OF Guilan University of Medical Sciences
City
Rasht
Postal code
4193713189
Approval date
2015-08-24, 1394/06/02
Ethics committee reference number
IR.GUMS.REC.1394.209
Health conditions studied
1
Description of health condition studied
Patients candidate for total hip arthroplasty
ICD-10 code
S79.7
ICD-10 code description
Multiple injuries of hip and thigh
Primary outcomes
1
Description
intraoperative and postoperative hemorrhage
Timepoint
after operation and 24 hours after that
Method of measurement
based on blod on suction and gauze counting and gilcher formula
Secondary outcomes
1
Description
packed cell
Timepoint
intraoperative and 24 hours after surgery
Method of measurement
number of packed cell
Intervention groups
1
Description
. In intravenous tranexamic acid group (15mg/kg), transamine will administer by anesthesiologist and based on body weight in a time of 10 minute. Before skin incision and surgery, all the patients receive only the intravenous form of tranexamic acid .Tranexamic acid is produced in CASPIAN TAMIN pharmaceutical co. Each vial consists of 500mg of tranexamic acid in 5 ml.
Category
Treatment - Drugs
2
Description
In tranexamic topical group,patients will recieve 3gr of tranexamic acid(6 vials) that diluted with normal saline intraoperatively by orthoped.After rimming of acetabulom 30 ml of above solution inserted in acetabulom and wound and keeping there about 1 minute. After broaching the femoral canal 30 ml of topical tranexamic acid inserted and keeping there about 1 min. the remain solution (30 ml )insert in the wound after hip joint reduction and will repaired.