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The Effect of Tranexamic acid and Intra-abdominal Pressure on Intraoperative Blood Loss in Lumbar Laminectomy

Protocol summary

Summary
This study will be performed as a double blind randomized clinical trial in candidates of lumbar laminectomy aged 15 to 65 years old. The study aimed to evaluate the effect of tranexamic acid and intra-abdominal pressure on intra-operative bleeding. 102 Patients will be allocated to TXA and Placebo groups with random block method. Exclusion criteria include history of renal, hepatic, and cardiac diseases, impaired PT and PTT, aspirin usage in previous two weeks, taking OCP, history of CVA, hypertension, morbid obesity. Intra-abdominal pressure in supine and prone position will be measured after induction of anesthesia. Before incision tranexamic acid 10mg/kg and normal saline 0.1ml/kg will be administered to TXA and Placebo groups consecutively. Then tranexamic acid 1mg/kg/h and normal saline 0.1ml/kg/h in similar syringes infused up to the end of procdure. Lab tests including PT, PTT, Hb, Hct., will be done before and after the procedure. Bleeding will be measured during the operation in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138708021388N1
Registration date: 2009-01-23, 1387/11/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2009-01-23, 1387/11/04
Registrant information
Name
anoush dehnadi moghadam
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1727 0456
Email address
dehnadi@gtrc.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Reaserch , Guilan University of Medical Sciences
Expected recruitment start date
2008-12-21, 1387/10/01
Expected recruitment end date
2009-06-20, 1388/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Tranexamic acid and Intra-abdominal Pressure on Intraoperative Blood Loss in Lumbar Laminectomy
Public title
The Effect of Tranexamic acid and Intra-abdominal Pressure on Intraoperative Blood Loss in Lumbar Laminectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: candidates for elective lumbar lamiectomy aged between 15 up to 65. Exclusion criteria: history of renal, hepatic, and cardiac diseases, impaired PT and PTT, aspirin usage in previous two weeks, taking OCP, history of CVA, hypertension, morbid obesity.
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of the vice chancellor for research
Street address
Namjoo st.,Shahid Siadati alley, Building of Research affairs, Guilan University of Medical Sciences
City
Rasht
Postal code
41446-65385
Approval date
empty
Ethics committee reference number
p/2007/132/3

Health conditions studied

1

Description of health condition studied
bleeding during lumbar laminectomy
ICD-10 code
T81.0
ICD-10 code description
T81.0

Primary outcomes

1

Description
mean volume of bleeding
Timepoint
all the time of operation
Method of measurement
to measure the volume of suctioned blood and weigh the collected gauze from the field

2

Description
mean intra-abdominal pressure
Timepoint
before the incision in supine position and after pronation
Method of measurement
to measure intra-vesical pressure by Foley catheter and CVP ruler

3

Description
mean of MAPs during the operation
Timepoint
every 5 minutes
Method of measurement
digital NIBP

Secondary outcomes

1

Description
mean volume of bleeding according to operated segments
Timepoint
all the time of operation
Method of measurement
to maesure the suctioned blood and weigh the collected gauze from the field

Intervention groups

1

Description
injection of normal saline 0.1ml/kg before the incision and then 0.1ml/kg/h
Category
Placebo

2

Description
injection of tranexamic acid 10mg/kg before the incision and then 1mg/kg/h
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Hospital,Trauma Research Center
Full name of responsible person
Dr.Anoush Dehnadi Moghadam
Street address
Bolvare Guilan, 177 st., No:92
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for reaserch , Guilan University of Medical Sciences
Full name of responsible person
Dr.Sobhani
Street address
Namjoo st., Shahid Siadati alley, Building of Research Affairs, Guilan University of Medical Sciences
City
Rasht
Grant name
Grant code / Reference number
p/2007/132/3
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for reaserch , Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr.Anoush Dehnadi Moghadam
Position
Assistant Professor of Anesthesiology, Fellowship in ICM
Other areas of specialty/work
Street address
Poursina Hospital, Trauma Research Center
City
Rasht
Postal code
41937-13191
Phone
+98 13 1323 8373
Fax
+98 13 1323 8373
Email
info@gtrc.ir
Web page address
www.gtrc.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr.Anoush Dehnadi Moghadam
Position
Assistant Professor of Anesthesiology, Fellowship in ICM
Other areas of specialty/work
Street address
Poursina Hospital,Trauma Research Center
City
Rasht
Postal code
41937-13191
Phone
+98 13 1323 8373
Fax
+98 13 1323 8373
Email
dehnadi@gtrc.ir
Web page address
www.gtrc.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan university of medical sciences
Full name of responsible person
Dr.Anoush Dehnadi Moghadam
Position
Assistant Professor of Anesthesiology, Fellowship in ICM
Other areas of specialty/work
Street address
Poursina Hospital,Trauma Reaserch Center
City
Rasht
Postal code
41937-13191
Phone
+98 13 1323 8373
Fax
+98 13 1323 8373
Email
dehnadi@gtrc.ir
Web page address
www.gtrc.ir

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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