Investigating the Effect of Transaxin Intravenous Acid on Reducing Post-Laminectomy Bleeding and Spinal Fibrinolysis
Design
This study was a randomized, randomized clinical trial on 60 patients with lumbar laminectomy and fissure
Settings and conduct
This study will be carried out at Tabriz Imam Reza Hospital in the form of a triple -blind, only the head nurse will be aware of it, and the patient and the patient will be unaware of it.
Participants/Inclusion and exclusion criteria
Criteria for inclusion in the study include patients aged 20-60 years who are candidates for laminectomy of 2 or more spaces, and fistula with a pedicelular screw (CD insertion) for any cause other than trauma, as well as having informed consent and reading skills. And writing. Exclusion criteria include the use of anticoagulant drugs such as ASA and depiridamole, high PT, PTT, INR for any cause, history of any thrombotic events, such as CVA and MI, history of bleeding disorders, history of TBI and history of CPR, kidney failure , Taking OCP, pregnancy or breastfeeding. Also, patients who have undergone blood transfusion before surgery for any reason will also be excluded from the study
Intervention groups
Patients between the ages of 20 and 60 who are candidates for laminectomy 2 or more space and fissure with a pedicle screw (CD insertion) for any cause other than trauma at the end of the surgery and before the final fixation and drainage of the trance Topical hexamic acid will be used
Main outcome variables
Transfusionized blood levels in patients undergoing surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N6
Registration date:2019-04-04, 1398/01/15
Registration timing:registered_while_recruiting
Last update:2019-04-04, 1398/01/15
Update count:0
Registration date
2019-04-04, 1398/01/15
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-18, 1397/12/27
Expected recruitment end date
2022-03-18, 1400/12/27
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:
Patients with candidate laminectomy and fissure-medial fistula, who refer to Imam Reza Hospital in Tabriz
all patients aged 20 to 60 years
Exclusion criteria:
Use of anticoagulant drugs such as ASA and depiridamole
high PT, PTT, INR for any cause
history of any thrombotic event such as CVA and MI
history of bleeding disorders
history of TBI
history of CPR
kidney failure
OCP use, pregnancy Or lactation.
Also, patients who need blood transfusion before or during surgery for any reason
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The selected patients will be divided into two groups of TXA receptors (n = 25) and placebo recipients (n = 25) according to the random numbers table. All surgical procedures in this study were performed by a surgical team and the technique used was similar.
The randomization in this study is that TXA (15 mg / kg) in single dose and placebo (normal saline 0.09%), which are pre-prepared with the names 1 and 2 in separate syringes, are exactly Prior to cutting by anesthetist technician, an uncontrolled intravenous anesthesia is administered to the patient and the patient is injected randomly, and then an operation is performed on the patient.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The selected patients who enter the operating room will be divided into two groups of TXA receptors (n = 25) and placebo recipients (n = 25) according to the random numbers table, which will be informed by the nurse of the operating room. And they will not be aware of it during the operation of the surgical team. All surgical procedures in this study were performed by a surgical team and the technique used was similar. The statistical analyzer is also unaware of the drug method. The basis of the study will be three blinds. After analysis, the head nurse will be asked the type 1 and 2 methods.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Medical science
Street address
Azadi Ave , Golghast St , Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
ir.tbzmed.rec.1397.1012
Health conditions studied
1
Description of health condition studied
Topical administration of TXA helps control bleeding and prevents unwanted side effects
ICD-10 code
M48.06
ICD-10 code description
Spinal stenosis, lumbar region
Primary outcomes
1
Description
Determination of the Effect of Tranexamic Acid on the Transfusion Level of Blood Transfusion in Patients under Laminectomy and Fibrous Fistula
Timepoint
During surgery and duration of hospitalization after surgery
Method of measurement
Blood volume injected to the patient in milliliters
2
Description
Determination of the Effect of Tranexamic Acid on the Length of Hospitalization During Laminectomy and Fistula
Timepoint
During surgery and duration of hospitalization after surgery
Method of measurement
Duration of hospitalization in hospital days
3
Description
Determine the effect of tranexamic acid on the amount of blood collected in hemovac in patients undergoing laminectomy and fissure of the posterolateral of the spine.
Timepoint
duration of hospitalization after surgery
Method of measurement
The amount of blood accumulated in CC
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients between the ages of 20 and 60 who are candidates for laminectomy 2 or more space and fissure with a pedicle screw (CD insertion) for any cause other than trauma at the end of the surgery and before the final fixation and drainage of the trance Topical hexamic acid will be used.
Category
Treatment - Drugs
2
Description
Control group: Patients aged between 20 and 60 years who are candidates for laminectomy of 2 or more spaces and fistula with a pedicle screw (CD insertion) for any cause other than trauma at the end of the surgery and before the final fixation and embedding Dren will use the drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mansour Valaie
Street address
Azadi St., Golghast St.,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 44 1333 8507
Fax
Email
Shakerym@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Tabriz University
Full name of responsible person
Ali Meshkini
Street address
Azadi St., Golghast St.,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 44 1446 9326
Email
Meshkini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Tabriz University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Moslem Shakeri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Golgasht ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 44 1333 8507
Email
shakeri@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mansour Valaie
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Golgasht ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 44 1333 8507
Email
mvalaie@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
Mansour valaie
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Golgasht ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 44 1333 8507
Fax
Email
mvalaie@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available