Protocol summary

Study aim
Determining the Effect of Transxamic Acid and Vitamin K in Preventing Bleeding in TURP Surgery
Design
Patients are divided into three groups of 25 people. The first group was given placebo (normal saline), the second group (tranexamic acid) and the third group were given vitamin K Clinical study of a randomized parallel, One-sided blind
Settings and conduct
Patients are divided into three groups of 25 people. The first group was given placebo (normal saline), the second group (tranexamic acid) and the third group were given vitamin K. The study is conducted at Khatam Al-Anbiya Hospital in Shahrood. Participants in the study are blind
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male gender, age 60 to 90 years, satisfaction with conducting prostatectomy through the duct Exclusion criteria include coagulation disorder (hemophilia, VWD, ITP, factor 5 deficiency), liver disease (cirrhosis, hepatitis, liver cancer), anticoagulant drugs (warfarin, heparin, enoxaparin, plavix), heart patients (history of MI Last year, Class 3 and 4heart failure , and arrhythmia such as AF), history of stroke, thrombotic disease, age less than 60 years of nonprostatic action, and dissatisfaction with participating in the study
Intervention groups
Patients are divided into three groups of 25 people. The first group was given placebo (normal saline), the second group (tranexamic acid) and the third group were given vitamin K
Main outcome variables
The incidence of hematuria, reduction in hemoglobin levels, changes in blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181031041515N1
Registration date: 2019-06-01, 1398/03/11
Registration timing: registered_while_recruiting

Last update: 2019-06-01, 1398/03/11
Update count: 0
Registration date
2019-06-01, 1398/03/11
Registrant information
Name
Milad Talezari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3522 2576
Email address
milad.tale72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Tranexamic Acid and Vitamin K in the prevention of hemorrhage in TURP surgery.
Public title
The Effects of Tranexamic Acid and Vitamin K in the prevention of hemorrhage in TURP surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male gender 60 to 90 year-old Satisfaction for performing TURP surgery
Exclusion criteria:
Coagulation disorders (hemophilia and ...) Liver Disease (Cirrhosis and ...) Uses of anticoagulant medication (Warfarin and Heparin and Plavix) History of heart disease History of thrombotic stroke
Age
From 60 years old to 90 years old
Gender
Male
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
The computerized block randomization (block sizes of 3 and 9) will carried out in this study. An independent clinical epidemiologist, who will not involved in the conduct of the study used a computerized block randomization program (STATA14 software) uses to produce the allocation codes.The randomization sequences will be concealed in lightproof, sealed envelopes.The research assistant opened sealed, numbered, opaque envelopes containing allocation codes. The eligible participants will be randomized to three equal groups (normal saline group, transxamic acid group and vitamin K group) according to the randomization list after signing informed consent form.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will not be aware of the type of medication they receive and the second executor of the research project will complete the questionnaire at the end of the treatment without knowledge of the three groups. Also the data will be analyzed without any information about group selection
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research of the Islamic Azad University of Shahroud Branch
Street address
Islamic Azad University of Shahrood Branch, Blvd university,Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3619943189
Approval date
2018-09-29, 1397/07/07
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1397.009

Health conditions studied

1

Description of health condition studied
Benign prostate Hyperplasia
ICD-10 code
N40
ICD-10 code description
Enlarged prostate

Primary outcomes

1

Description
Bleeding status after TURP surgery
Timepoint
Within 48 hours after surgery
Method of measurement
Volume of fluid in the urethra for hematuria, the amount of hemoglobin before and after surgery

Secondary outcomes

1

Description
The amount of bleeding during and after the TURP operation
Timepoint
During and after the TURP operation
Method of measurement
Hemoglobin level and serum volume of used washing

Intervention groups

1

Description
Intervention group: Ampol of 1 vial of Transamin 500 mg (Caspian Company Rasht Drug) will be injected into the serum during an operation in the Tranexamic Acid group.
Category
Treatment - Drugs

2

Description
Intervention group: Vitamin K ampol with dosage 10 mg (Osvah Pharmaceutical company) will be injected intra-muscularly in the vitamin K group 8 hours prior to surgery.
Category
Treatment - Drugs

3

Description
Control group: The normal serum saline (Tehran Pharmacy Company) will be administered to the control group during surgery.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al-Anbiya Hospital in Shahrood
Full name of responsible person
Milad Talezari
Street address
No.45 ، First Alley، Mofateh St ، Station St
City
ُُShahroud
Province
Semnan
Postal code
3616643417
Phone
+98 23 3224 2487
Email
milad.tale72@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahebali Monafi
Street address
University Blvd - Shahrud Islamic Azad University
City
Shahroud
Province
Semnan
Postal code
3619943189
Phone
+98 23 3239 4530
Email
shahrood.azad.university@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Yousef Kolookhi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.45 , First Alley , Mofateh St , station St
City
Shahroud
Province
Semnan
Postal code
3616643417
Phone
+98 23 3224 2487
Email
dryousefkolookhianestezi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Yousef Kolookhi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
University Blvd - Shahrud Islamic Azad University
City
Shahroud
Province
Semnan
Postal code
3619943189
Phone
+98 23 3239 4530
Email
dryousefkolookhianestezi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Milad Talezari
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
University Blvd - Shahrud Islamic Azad University
City
Shahroud
Province
Semnan
Postal code
3619943189
Phone
+98 23 3239 4530
Email
milad.tale72@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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