The aim of this study was to evaluate the effect of Tranexamic acid on bleeding and hemoglobin level in patients with staghorn calculi underwent percutaneous nephrolithotomy
Design
Studies groups: patients with staghorn calculus(kidney stone)
ُُStudy:Randomized , blinded, sham controlled clinical trial with a parallel group
The size of sample was 120
clinical trial phase: phase 3
Settings and conduct
Place of study: Alzahra Hospital, Isfahan
Patients according to stone size were divided to two group (n=60). Then these patients were randomly divided into two groups(case and control)
The study is a double blind clinical trial. The patient and the caregiver did not know how to allocate placebo and drug for patients
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with staghorn calculi candidate for percutaneous nephrolithotomy surgery.
exclusion criteria: renal failure, consumption of vitamin E, Aspirin and warfarin and creatinine more than 15
Intervention groups
Intervention group: transaxamic acid (as drug)
Control group: normal salin (as placebo)
Main outcome variables
Bleeding; Hemoglobin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180209038673N1
Registration date:2018-04-17, 1397/01/28
Registration timing:retrospective
Last update:2018-04-17, 1397/01/28
Update count:0
Registration date
2018-04-17, 1397/01/28
Registrant information
Name
Robab Sheikhpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3623 5958
Email address
r.sheikhpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-01-31, 1395/11/12
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
2017-01-31, 1395/11/12
Actual recruitment end date
2017-10-23, 1396/08/01
Trial completion date
empty
Scientific title
The effect of Tranexamic acid on bleeding and hemoglobin level in patients with staghorn calculus
Public title
ٍٍEffect of Tranexamic acid in treatment of surgical bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with staghorn calculus candidate for percutaneous nephrolithotomy surgery
Exclusion criteria:
renal failure
creatinine more than 15
consumption of vitamin E, Aspirin and warfarin
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
We divide each referral into two groups using a randomized table. This table is a collection of numbers. Consider numbers from 1 to 30 for intervention A and numbers 31 to 60 for control B(for both group size more and less than 4 cm). Then let's move on one of the numbers and move in one of the preset directions and assign the numbers to one of the groups. Thus, patients are completely randomly divided
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients did not aware about prescription drugs (placebo and medication). Also, the person who provided these drugs to patients had no information about the allocation of patients to drug or placebo
Placebo
Used
Assignment
Parallel
Other design features
In this study, 120 patients with kidney stones are divided into two groups based on stone size (larger and smaller than 4 cm). Then, patients in both groups were randomly divided into two groups (drug and placebo)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Science,Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-01-31, 1395/11/12
Ethics committee reference number
295188
Health conditions studied
1
Description of health condition studied
staghorn calculus kidney
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Bleeding
Timepoint
One week after the end intervention
Method of measurement
The amount of blood intake
Secondary outcomes
1
Description
Hemoglobin
Timepoint
One week after the end intervention
Method of measurement
CBC analysis
Intervention groups
1
Description
Intervention group: Administration of 1 grTranexamic acid every 12 hours for a week(group with size more and less than 4 cm)
Category
Treatment - Drugs
2
Description
Control group: Normal Salin (group with size more and less than 4 cm)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mehrdad Mohammadi
Street address
Alzahra hospital, Soffeh Blvd, Keshvari Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mehrdad.mohammadi981@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Reseach depurty of Isfahan University of Medical Science
Full name of responsible person
Ahmad Movahedian attar
Street address
Isfahan University of Medical Science,Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
mehrdad.mohammadi981@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reseach depurty of Isfahan University of Medical Science
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
Esfahan University of Medical Sciences
Full name of responsible person
Abbas Barzegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Isfahan University of Medical Science,Hezar Jarib street, Isfahan
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
mehrdad.mohammadi981@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abbas Barzegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Isfahan University of Medical Science,Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
mehrdad.mohammadi981@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abbas Barzegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Isfahan University of Medical Science,Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
817467573
Phone
+98 31 3620 2020
Email
mehrdad.mohammadi981@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD