Assessment of topical tranexamic effect on postoperative hemoglobin in patient undergoing percutaneous nephrolithotomy
Design
A randomized controlled clinical trial, double-blind, with parallel groups, on 90 patients
Settings and conduct
In this double-blind clinical trial study, 90 patients undergoing percutaneous nephrolithotomy were randomly divided into two groups, topical tanzanexamic acid and control (without tranexamic acid injection). In the intervention group, 1 gr of tranexamic acid was diluted in 100 ml of normal saline and injected into the nephrostomy drain immediately after surgery. The variables studied in this study included comparison of two groups for hemoglobin before and 48 hours after surgery, and number of days hospitalized. In this study, clinical care giver and statistical analyzer were not aware of groups assigned to patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria were age between 18-65 years, ASA class <III and absence of coagulopathy. Exclusion criteria included the need for Double J insertion, prediction of need for blood transfusions during surgery, and dyscrasia.
Intervention groups
Intervention group: Topical injection of tranexamic acid in nephrostomy drain - Control group: Non-injection of tranexamic acid
Main outcome variables
Hemoglobin, hospital stay days, stone free rate (SFR)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180625040232N2
Registration date:2020-03-25, 1399/01/06
Registration timing:retrospective
Last update:2020-03-25, 1399/01/06
Update count:0
Registration date
2020-03-25, 1399/01/06
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
2020-01-01, 1398/10/11
Expected recruitment end date
2020-02-18, 1398/11/29
Actual recruitment start date
2020-01-01, 1398/10/11
Actual recruitment end date
2020-03-04, 1398/12/14
Trial completion date
2020-03-04, 1398/12/14
Scientific title
Assessment of topical tranexamic effect on postoperative hemoglobin in patient undergoing percutaneous nephrolithotomy
Public title
Effect of topical tranexamic on hemoglobin
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
Prediction of need to transfusion during surgery
Having dyscrasia
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
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
In this study, clinical care giver and statistical analyzer were not aware of groups assigned to patients.
Placebo
Not 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
Urmia University of Medical Sciences-Resalat Blvd-Emergency Alley, Urmia, Vest Azarbaijan
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-12-30, 1398/10/09
Ethics committee reference number
IR.UMSU.REC.1398.422
Health conditions studied
1
Description of health condition studied
Hemorrhagia
ICD-10 code
D68.32
ICD-10 code description
Hemorrhagic disorder due to extrinsic circulating anticoagulants
Primary outcomes
1
Description
Hemoglobin
Timepoint
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
2
Description
Stone free rate (SFR)
Timepoint
Once, when leaving the operating room
Method of measurement
Using Portable Radiological Device (C-arm)
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 (not intravenously) immediately after surgery. The catheter is then clamped for 30 minutes to prevent leakage.
Category
Treatment - Drugs
2
Description
Control group: In this group, routine procedures were performed after percutaneous nephrolithotomy. Therefore, tranexamic acid is not routinely administered, so it was not injected in this group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital of Urmia
Full name of responsible person
Vahid Rezvankhah
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Urmia University of Medical Sciences-Resalat Blvd-Emergency Alley. Urmia Vest Azarbaijan