Assessment of intraoperative Local administration of tranexamic acid effect on haemorrhage in patients undergoing open prostatectom
Design
Clinical trial with control group, with parallel groups, single blinded, randomized, phase 3 on 140 patients
Settings and conduct
In this randomized, single-blind, phase 3 clinical trial, 140 eligible patients referred to Imam Khomeini hospital in Urmia undergoing open prostatectomy are selected to receive tranexamic acid topically.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-80 years-Having no coagulopathy-Consent to participate in the study. Exclusion criteria: Sensitivity to tanxemaci acid-History of severe heart problems (high risk, very high risk) based on Pre-operative cardiac risk assessment
Intervention groups
In the intervention group, 1 gr of tranexamic acid is diluted in 100 cc of normal saline and injected into the prostate fossa during surgery. After surgery, up to 3 doses of 1 gr which are injected into the lavage serum, and then the bladder and prostate fossa are washed. The control group will be washed with normal saline only.
Main outcome variables
Hemoglobin level, length of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180625040232N8
Registration date:2022-03-26, 1401/01/06
Registration timing:prospective
Last update:2022-03-26, 1401/01/06
Update count:0
Registration date
2022-03-26, 1401/01/06
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
2022-04-03, 1401/01/14
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of intraoperative Local administration of tranexamic acid effect on haemorrhage in patients undergoing open prostatectom
Public title
Intraoperative Local administration of tranexamic acid effect on haemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-80 years
Having no coagulopathy
Consent to participate in the study
Exclusion criteria:
Sensitivity to tranexamic acid
History of severe heart problems (high risk, very high risk) based on pre-operative cardiac risk assessment
Age
From 18 years old to 80 years old
Gender
Male
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects; it means we will have 35 blocks (Totally 140 patients). Then, within each block, subjects will be randomly assigned to intervention or control group . Random assignment will be done using a random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
Given that the surgical technique should be reported to patients preoperatively , the researcher and patients participating in the study should be aware of the surgical technique, but the analyst is unaware of which patient belongs to which intervention group.
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
UMSU Central Site, Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-04-07, 1400/01/18
Ethics committee reference number
IR.UMSU.REC.1400.030
Health conditions studied
1
Description of health condition studied
Hemorrhage following prostatectomy due to enlarged prostate
ICD-10 code
N40
ICD-10 code description
Enlarged prostate
Primary outcomes
1
Description
Hemoglobin level
Timepoint
Before surgery and 48 hours after surgery
Method of measurement
Blood test
Secondary outcomes
1
Description
length of hospital stay
Timepoint
Once, at the discharge time
Method of measurement
patient's file
Intervention groups
1
Description
Intervention group: In the intervention group, 1 gr of tranexamic acid (produced by Caspian company) is diluted in 100 cc of normal saline and injected into the prostate fossa during surgery. After surgery, up to 3 doses of 1 gr which are injected into the lavage serum, and then the bladder and prostate fossa are washed.
Category
Treatment - Drugs
2
Description
Control group: The control group will be washed with normal saline only.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Imam Khomeini hospital
Full name of responsible person
Saman Farshid
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