Effectiveness of topical Tranexamic Acid for reducing bleeding in prostate surgeries
Design
This study is clinical trial and double blind.93 patients candidate for prostate surgery in Valiasr Hospital in Arak will inter this study.We will divide patients in 3 groups by simple randomization.Groups are parallel.
Settings and conduct
This study is clinical trial and double blind.93 patients candidate for prostate surgery in Valiasr Hospital in Arak will inter this study.Outcome assessor and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Ages over 18 years, ASA class 1 and 2, prostate weight less than 150 gram, hemoglobin greater than or equal to 10, body mass index less than 35
Exclusion criteria: Coagulopathy, history of prostate cancer, addiction to opioids, pre-surgical Finasteride treatment history, history of atrial fibrillation and coronary artery disease, thrombophilia, dissatisfaction
Intervention groups
Group 1: Tranexamic Acid (Iran-Rasht Caspian Vial Pharmaceutical Company 0.5 x 5 ml) was administered according to the following protocol: 20 minutes before surgery 15 milligram in kilogram Tranexamic acid body weight (Diluted with 100 milliliter of normal saline) was slowly infused over a period of 20 minutes as an intravenous infusion.
Group II: Patients are given 1 gram oral Tranexamic acid (Made in Iran - 250 milligram Amin Capsule Pharmaceuticals) 30 minute before surgery.
Group III: 1 g is poured into 10 milliliter and poured topically (Made in Iran-Rasht Caspian Pharmaceutical Company) at the surgical site.
Main outcome variables
Bleeding rate, surgeon satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N134
Registration date:2020-03-05, 1398/12/15
Registration timing:registered_while_recruiting
Last update:2020-03-05, 1398/12/15
Update count:0
Registration date
2020-03-05, 1398/12/15
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-09, 1398/06/18
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of topical Tranexamic Acid for reducing bleeding in prostate surgeries
Public title
Effectiveness of topical Tranexamic Acid for reducing bleeding in prostate surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages over 18 years
ASA class 1 and 2
Prostate weight less than 150 gram
Hemoglobin greater than or equal to 10
Body mass index less than 35
Exclusion criteria:
Coagulopathy
History of prostate cancer
Addiction to Opioids
Pre-surgical Finasteride treatment history
A history of atrial fibrillation and coronary artery disease
Thrombophilia
Dissatisfaction
Age
From 18 years old
Gender
Male
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two groups A and B and C.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B and C are available to analyzer and outcome assessor.Group A received placebo infusion and group B received serum infusion tablets.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-09-08, 1398/06/17
Ethics committee reference number
IR.ARAKMU.REC.1398.166
Health conditions studied
1
Description of health condition studied
Prostate surgery
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate
Primary outcomes
1
Description
Bleeding rate
Timepoint
During surgery
Method of measurement
Observation
2
Description
Surgeon satisfaction
Timepoint
During surgery
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Tranexamic Acid (Iran-Rasht Caspian Vial Pharmaceutical Company 0.5 x 5 ml) was administered according to the following protocol: 20 minutes before surgery 15 milligram in kilogram Tranexamic acid body weight (Diluted with 100 milliliter of normal saline) was slowly infused over a period of 20 minutes as an intravenous infusion.They are given a placebo to blindly receive a tablet similar to the tranexamic acid pill.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients are given 1 gram oral Tranexamic acid (Made in Iran - 250 milligram Amin Capsule Pharmaceuticals) 30 minute before surgery.Serum is also given to patients for blindness.
Category
Treatment - Drugs
3
Description
Intervention group 3: 1 gram Tranexamic acid is poured into 10 milliliter and poured topically (Made in Iran-Rasht Caspian Pharmaceutical Company) at the surgical site.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Afsaneh Norouzi
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
Nourozi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Afsaneh Noruzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street