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Effect of topical tranexamic acid in control of lower urinary system bleeding in emergency department

Protocol summary

Summary
The purpose of this study is to evaluate the effects of topical Tranexamic acid in control of lower urinary tract bleeding. 50 Patients older than 40 years old with gross hematuria will be included in this study who referred to emergency department of Imam Reza (AS) Hospital, Tabriz. Exclusion criteria include pregnancy, lactation, history of thrombosis or thromboembolism, coagulopathy, history of myocardial infarction or ischemic stroke, renal failure, urinary tract infarction, and disagreement to contribute to the research. In these patients, bladder will be irrigate with 1 liter of Normal Saline 0.9% serum first, then patients will be divided into 2 groups randomly. For intervention group, 500 mg Tranexamic acid in 500cc Normal Saline 0.9% will be administered via 3 branch Foley catheter. For control group, 10 cc pure water in 500 cc normal saline 0.9% will be used for bladder irrigation as placebo. Tranexamic acid & pure water were prepared in different 10 cc syringes by researcher that both of physician & patient are unaware about them. Then all patients will be admitted to urology ward for 24 hours. Amount of hematuria will be checked by urinary test tape before intervention, 1, 3, 6, and 24 hours after intervention. Also, we will check hemoglobin level at arrival time, 6, and 24 hours after it.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014072118545N1
Registration date: 2015-02-25, 1393/12/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-25, 1393/12/06
Registrant information
Name
Seyed Hossein Ojaghi Haghighi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2078
Email address
haghighis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of topical tranexamic acid in control of lower urinary system bleeding in emergency department
Public title
Effect of topical tranexamic acid in control of urinary bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : (patient over 40 years old; lower urinary system bleeding like clot or fresh blood). Exclusion criteria : (pregnancy; lactation; history of thrombosis or thromboemboli; coagulopathy; history of myocardial infarction or ischemic stroke; renal failure; urinary tract infarction; disagreement to contribute to research)
Age
From 40 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization of study will done with computerize program and patient will divided to group 1 and 2. Every group has 25 patients.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of Vice Chancellor for Research of Tabriz University of Medical Sciences
Street address
Golgasht avenue, Tabriz university medical science
City
Tabriz
Postal code
5166614756
Approval date
2014-05-05, 1393/02/15
Ethics committee reference number
5/4/1251

Health conditions studied

1

Description of health condition studied
Haematuria
ICD-10 code
ٔٔR31
ICD-10 code description
Unspecified haematuria

Primary outcomes

1

Description
Haematuria
Timepoint
0,1,3, and 24 hours
Method of measurement
Urinary test tape

Secondary outcomes

1

Description
Haemoglobin
Timepoint
0, 6, and 24 hours
Method of measurement
CBC Analysis

Intervention groups

1

Description
For intervention group, We will administer 500 mg tranexamic acid (500mg/5cc, Tranexip, Caspiantamin Drug Group, Iran) in 500cc N/S for bladder irrigation.
Category
Treatment - Drugs

2

Description
For control group, we will use 500 cc N/S with 10 cc pure water as placebo for bladder irrigation.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Medical Research and Training Hospital
Full name of responsible person
Arezoo Farjamnia
Street address
Golgasht avenue
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohamadreza Rashidi
Street address
Golgasht Avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Science
Full name of responsible person
Seyed Hossein Ojaghi Haghighi
Position
Medical Doctor/ Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Golgasht Avenue
City
Tabriz
Postal code
5166614756
Phone
+98 41 3335 2078
Fax
+98 41 3335 2078
Email
haghighis@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical science
Full name of responsible person
Seyed Hossein Ojaghi Haghighi
Position
Medical Doctor/ Assistant professor of emergency medicine
Other areas of specialty/work
Street address
Golgasht street
City
Tabriz
Postal code
5166614756
Phone
+98 41 3335 2078
Fax
+98 41 3335 2078
Email
haghighis@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Arezoo Farjamnia
Position
Medical Doctor/ Assistant of Emergency Medicine
Other areas of specialty/work
Street address
Golgasht Avenue
City
Tabriz
Postal code
Phone
+98 41 3335 2078
Fax
Email
arezoo_far@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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