There are new studies about positive effects of TXA; Reduce in bleeding after posterolateral fusion surgeries and some level laminectomies could be interesting clinically; so this study designed. Inclusion Criteria: age between 18 to 60 years old; patients underwent for laminectomy surgery ( 2 level or more) and posterolateral fusion with pedicule screws for reason other than trauma , Informed consent
Exclusion Criteria: Anticoagulant drugs use such as A.S.A and dipyridamole; Increased in PT, PTT, INR; History of CVA, MI, bleeding disorder, TBI, CPR, Renal Failure, OCP; Pregnancy and breastfeeding 5- Patients received pack cell before or during the operation.
Patients will be divided in 2 groups based on tables of random numbers. Case group will receive TXA 15 mg/kg for single dose (N=25) and control group will receive placebo (N=25). All surgical technique is the same for both group. After moving to section the amount of bleeding in hemobag in period of first 12 hours and the second 12 hours will measured. Blood loss during the operation and need to transfusion, the duration of hospitalization and side effects will compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020913947N6
Registration date:2017-04-14, 1396/01/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-14, 1396/01/25
Registrant information
Name
Atta Mahdkhah
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1332 6196
Email address
mshimia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the efficacy of Tranexamic Acid in reducing blood loss after laminectomy and postrolateral fusion of spine
Public title
Assessment the efficacy of Tranexamic Acid in reducing blood loss after laminectomy and postrolateral fusion of spine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:age between 18 to 60 years old ; patients underwent for laminectomy surgery ( 2 level or more) and posterolateral fusion with pedicule screws for reason other than trauma ; Informed consent
Exclusion Criteria: Anticoagulant drugs use such as A.S.A and dipyridamole; Increased in PT, PTT, INR ; History of CVA, MI, bleeding disorder, TBI, CPR, Renal Failure, OCP; Pregnancy and breastfeeding; Patients received pack cell before or during the operation
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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 and Research,Tabriz University of Medical Sciences
Street address
Tabriz
City
Tabriz
Postal code
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.TBZMED. REC.1395.1292
Health conditions studied
1
Description of health condition studied
Anticoagulant drug
ICD-10 code
Y44.3
ICD-10 code description
Anticoagulant antagonists, vitamin K and other coagulants
Primary outcomes
1
Description
blood loss
Timepoint
First and 12 hours after surgery and
Method of measurement
First and 12 hours after surgery and the amount of suctioned during surgery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive TXA 15 mg/kg for single dose
Category
Treatment - Drugs
2
Description
Control group: will receive placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Moslem Shakeri
Street address
Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences, Golgasht St, Tabriz, Iran
Full name of responsible person
Moslem Shakeri
Street address
Tabriz, East Azarbaijan, Iran
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, Tabriz University of Medical Sciences, Golgasht St, Tabriz, Iran
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
Moslem Shakeri
Position
Professor
Other areas of specialty/work
Street address
Tabriz
City
tabriz
Postal code
Phone
+98 41 3337 6953
Fax
Email
moslemshakeri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Moelem Shakeri
Position
Professor
Other areas of specialty/work
Street address
Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 6953
Fax
Email
moslemshakeri@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Department of neurosurgery
Full name of responsible person
Moslem Shakeri
Position
Professor
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
+98 41 3337 6953
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)