Effect of examines the effects of TXA on bleeding during and after PCNL.
Design
The intervention and control group each included 54 individuals who were randomly allocated. The intervention group received TXA (1gr at the beginning and 5mg every 8hrs for 3days) and the control group received placebo capsules (starch) of the same form and dose. The surgeon and patients were blind to the allocation of participants.
Settings and conduct
Totally, 108 patients in Imam Khomeini Hospital in Urmia– Iran took part in this double blind clinical trial study in 2013-2014.
Participants/Inclusion and exclusion criteria
Inclusion criteria were having kidney or ureteral stone (stones bigger than 2cm at pelvic or upper calices and bigger than 1.5cm of lower calices), failed ESWL, and candidate of PCNL. In addition, patients with a history of DVT, PTE, and Cr>1.5, drug allergy, cerebral arteries damage or SAH, color blindness, using OCP pills, using coagulation factors, surgery and heartvalve transplantation were excluded.
Intervention groups
tranexamic acid
Main outcome variables
Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180625040232N4
Registration date:2020-06-17, 1399/03/28
Registration timing:retrospective
Last update:2020-06-17, 1399/03/28
Update count:0
Registration date
2020-06-17, 1399/03/28
Registrant information
Name
Saman Farshid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
farshid.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
2013-08-23, 1392/06/01
Actual recruitment end date
2014-05-20, 1393/02/30
Trial completion date
2014-05-20, 1393/02/30
Scientific title
The effects of tranexamic acid on bleeding control during and after percutaneous nephrolithotomy (PCNL)
Public title
The effects of tranexamic acid on bleeding control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 years
ASA class >III
Not having coagulopathy
Exclusion criteria:
Need to embed Double J Stent
Prediction of need to transfusion during surgery
Patients with coagulopathy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
108
Actual sample size reached:
108
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all eligible patients were assigned to control and intervention (tranexamic ) groups using random sequence extraction from the computer (via www.randomization.com) and simple randomization. The resulting random numbers, i.e. the allocation of patients to groups, was concealed using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Random allocation was made among patients and assigned to Card Intervention Group No. 1 and to Plasbo Card Group No. 2. Participants and clinical caregivers were unaware of the allocation of individuals in each of the study groups involved and the placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Resalat Blvd-Emergency Alley, Urmia, Vest Azarbaijan
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2013-12-03, 1392/09/12
Ethics committee reference number
IR.UMSU.REC.1392.162
Health conditions studied
1
Description of health condition studied
Bleeding
ICD-10 code
D68.32
ICD-10 code description
Hemorrhagic disorder due to extrinsic circulating anticoagulants
Primary outcomes
1
Description
Bleeding
Timepoint
24 hours before surgery and 48 hours after surgery
Method of measurement
Blood sampling
Secondary outcomes
1
Description
Hospital stay days
Timepoint
Once, at the time of discharge
Method of measurement
Calculating hospital stay days from admission to discharge
Intervention groups
1
Description
Intervention group: In the intervention group, 1 gr of tranexamic acid (Caspian Tamin Pharmaceutical Company) is diluted in 100 ml normal saline and injected into nephrostomy drain (intravenously) immediately after surgery. The catheter is then clamped for 30 minutes to prevent leakage.
Category
Treatment - Drugs
2
Description
Control group: In the control group received placebo (1gr at the beginning and 5mg every 8hrs for 3days) capsules (starch) of the same form and dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital of Urmia
Full name of responsible person
Saman Farshid
Street address
Imam Khomeini hospital, Ershad Ave, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 9931
Email
Farshid.s@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Street address
Resalat Blvd-Emergency Alley. Urmia Vest Azarbaijan
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
Farshid.s@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Urmia University of Medical Sciences
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
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Khomeini hospital, Ershad Ave, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 9931
Email
samanf63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Khomeini hospital, Ershad Ave, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 9931
Email
Farshid.s@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Khomeini hospital, Ershad Ave, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 9931
Email
Farshid.s@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Any information without the need for patients' names will be available
When the data will become available and for how long
Six months after publication
To whom data/document is available
Faculty members of medical universities
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
Email to Dr. Saman Farshid farshid.s@umsu.ac.ir
What processes are involved for a request to access data/document