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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2014072118545N1 |
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Date of registration:
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2015-02-25 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of topical tranexamic acid in control of urinary bleeding
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Scientific title:
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Effect of topical tranexamic acid in control of lower urinary system bleeding in emergency department |
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Date of first enrolment:
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2014-09-23 |
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Target sample size:
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50 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/16784 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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.
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Phase:
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2-3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Seyed Hossein Ojaghi Haghighi
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Address:
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Golgasht Avenue
5166614756
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 3335 2078 |
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Email:
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haghighis@tbzmed.ac.ir |
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Affiliation:
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Tabriz University of Medical Science |
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Name:
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Seyed Hossein Ojaghi Haghighi
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Address:
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Golgasht street
5166614756
Tabriz
Iran (Islamic Republic of) |
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Telephone:
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+98 41 3335 2078 |
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Email:
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haghighis@tbzmed.ac.ir |
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Affiliation:
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Tabriz university of medical science |
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Key inclusion & exclusion criteria
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Inclusion 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)
Exclusion criteria:
Age minimum:
40 years
Age maximum:
100 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Unspecified haematuria
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Haematuria.
Unspecified haematuria
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Intervention(s)
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For control group, we will use 500 cc N/S with 10 cc pure water as placebo for bladder irrigation.
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For intervention group, We will administer 500 mg tranexamic acid (500mg/5cc, Tranexip, Caspiantamin Drug Group, Iran) in 500cc N/S for bladder irrigation.
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Intervention 1: For intervention group, We will administer 500 mg tranexamic acid (500mg/5cc, Tranexip, Caspiantamin Drug Group, Iran) in 500cc N/S for bladder irrigation. Intervention 2: For control group, we will use 500 cc N/S with 10 cc pure water as placebo for bladder irrigation.
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Placebo
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Treatment - Drugs
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Primary Outcome(s)
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Haematuria. Timepoint: 0,1,3, and 24 hours. Method of measurement: Urinary test tape.
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Secondary Outcome(s)
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Haemoglobin. Timepoint: 0, 6, and 24 hours. Method of measurement: CBC Analysis.
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Source(s) of Monetary Support
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Tabriz University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethical committee of Vice Chancellor for Research of Tabriz University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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