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Effect of intraoperative infusion of Tranexamic acid on blood loss volume during Femoral Fracture Surgery: A double-blinded clinical trial

Protocol summary

Summary
In current prospective randomized double-blinded clinical trial, 60 patients, candidate for femoral fracture surgery with conture, with grade I or II of American society of anesthesiology (ASA), will be evaluated. Patients with hypersensitivity to tranexamic acid, coagulopathies and pregnancy will be excluded. All patients will undergo routine heparin administration, a day before surgery and required laboratory tests including coagulation factors and complete blood count will be collected. Anesthesia will be inducted using propofol, fentanyl, midazolam and atracurium. Patients randomly will be assigned to study groups via RAS software. In study group, 10 mg/kg tranexamic acid will be administered during 15 minutes prior to incision, and will be infused during surgery with dosage of 1 mg/kg/hr till end of the surgery. In control group, patients will receive normal saline serum as placebo in same volume of tranexamic acid during surgery. Maximum allowable blood loss formula will be used to evaluate intraoperative bleeding. Whereas, Intraoperative blood loss will be estimated by blinded anesthesiologist, using blood collected in suction reservoir and blood smeared gausses. During surgery and postoperatively, variables such as intraoperative bleeding, postoperative bleeding and blood transfusion during and after surgery will be assessed and recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050126328N3
Registration date: 2017-06-27, 1396/04/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-27, 1396/04/06
Registrant information
Name
Masoud Parish
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 5842
Email address
parishm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2018-04-04, 1397/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intraoperative infusion of Tranexamic acid on blood loss volume during Femoral Fracture Surgery: A double-blinded clinical trial
Public title
Controlling femoral fracture surgery bleeding by tranexamic acid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate for femoral fracture surgery using conture; Class I or II according to ASA classification; aged more than 18 years old. Exclusion criteria: hypersensitivity to tranexamic acid; anemia (hemoglobin lower than 8 gram per 100 milliliter); avoidance from blood transfusion; history of anticoagulant consumption; history of coagulopathies; history of thromboembolism; history of cerebrovascular accidents; history of ischemic heart diseases; pregnancy; major cardiac or pulmonary diseases; hepatic or renal failure; history of epilepsy; history of re-surgery.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be performed using table of random numbers via RAS software.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz university of medical sceinces, Daneshgah square
City
Tabriz
Postal code
Approval date
2017-04-10, 1396/01/21
Ethics committee reference number
IR.TBZMED.REC.1396.14

Health conditions studied

1

Description of health condition studied
Femoral fracture intraoperative bleeding
ICD-10 code
S72
ICD-10 code description
Fracture of femur

Primary outcomes

1

Description
blood loss volume in drain reservoir
Timepoint
during operation and till darin discharge
Method of measurement
maximum allowable blood loss formula

Secondary outcomes

1

Description
volume of blood transfusion
Timepoint
during operation and during admission
Method of measurement
C.C.

Intervention groups

1

Description
Intervention group: 15 minutes prior to incision, 10 mg/kg tranexamic acid will be administered and will be infused during surgery with dosage of 1 mg/kg/hr till end of the surgery.
Category
Treatment - Drugs

2

Description
Control group: 15 minutes prior to incision, 10 mg/kg normal saline (placebo) will be administered and will be infused during surgery with dosage of 1 mg/kg/hr till end of the surgery.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Dr. Masoud Parish
Street address
Shohada hospital, Golshahr street, Yaxchian, Tabriz, Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
City
Tabriz
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 Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Masoud Parish
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Shohada hospital, Golshahr street, Yaxchian, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
Fax
Email
parishm@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Masoud Parish
Position
Associate Professor, Specialist in anesthesiology
Other areas of specialty/work
Street address
Shohada hospital, Golshahr street, Yaxchian, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
Fax
Email
parishm@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Masoud Parish
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Shohada hospital, Golshahr street, Yaxchian, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
Fax
Email
parishm@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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