The aim of this study investigate the effect of Tranexamic acid in prostate surgery(TURP). Patients with BPH that are over 50 years of age are cathegorized as class 1 -3 ASA and their prostate gland weights less than 80 grams, not carrying PCA( Prostate Cancer Antigen), PSA≤4 ng/ml and are candidates for TURP with no indication for open surgery are included in ithis study. patients are randomly divided into two groups. First group recieves . Second group ( control group) recieves Normal saline
( placebo) instead ( to the same volume as the first group). All patients undergo spinal anesthesia. patient's Hemoglobin levels are measured one hour after the start of surgery, then right after patient is taken to recovery room, then again 6 and 24 hours after surgery. For any of the samples that Hemoglobin is less than 10 g/dl, packed cell Isogroup and RH is added to keep hemoglobin over 10 g/dl. Then results in two groups are compared and softwares are used to analyze and do the statistics.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904164345N1
Registration date:2013-08-13, 1392/05/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-13, 1392/05/22
Registrant information
Name
Ali Mirmansouri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 9064
Email address
a_mirmansoori@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2013-06-18, 1392/03/28
Expected recruitment end date
2013-12-19, 1392/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical tial on the effects of intravenous tranexamic acid on amount of transfusion in patients undergoing trans urethral resection of prostate(TURP)
Public title
Control of bleeding in prostate surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Patients with BPH; that are over 50 years of age; cathegorized as class 1 -3 ASA ; their prostate gland weights less than 80 grams; not carrying PCA( Prostate Cancer Antigen), by sonography , ; PSA≤4 ng/ml; no history of prostatic Cancer.
Exclusion criteria:Duration of surgery is more than 3 hours ; other condition which complicats surgery.
Age
From 50 years old to 100 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Namjoo Avenue,Deputy department
City
Rasht
Postal code
4193833697
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
1920101204
Health conditions studied
1
Description of health condition studied
BPH
ICD-10 code
N42.3
ICD-10 code description
Dysplasia of prostate Low grade dysplasia
Primary outcomes
1
Description
Hematocrit
Timepoint
one hour after the start of surgery, then right after patient is taken to recovery room, then again 6 and 24 hours after surgery.
Method of measurement
%,sysmex kx-21
2
Description
Hemoglobin
Timepoint
one hour after the start of surgery, then right after patient is taken to recovery room, then again 6 and 24 hours after surgery.
Method of measurement
g/dl,Sysmex k x-21
3
Description
PSA
Timepoint
before surgery
Method of measurement
ng/ml, Elisa
4
Description
Blood pressure
Timepoint
Every 5 Minutes
Method of measurement
mmHg with NIBP
Secondary outcomes
empty
Intervention groups
1
Description
First group that recieved Tranexamic acid after anesthisia 15 mg/kg that dilute in 100 cc normal saline inject during 15 minutes, to be continued with 1mg/kg/1h during 5 hours.
Category
Treatment - Drugs
2
Description
Second group ( control group) recieve Normal saline
( placebo) instead ( to the same volume as the first group).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Anesthisia research centre
Full name of responsible person
Ali mirmansouri
Street address
Namjoo Avenue, research centre, Velaiat hospital
City
Rasht
2
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Ali mirmansouri
Street address
Sardar jangal Avenue.Razi hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Abdol Rasool sobhani
Street address
Emam Khomeini Blv.,top of the Iran Radiator Co.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Ali mirmansouri
Position
Assistant Professor
Other areas of specialty/work
Street address
Namjoo Avenue, Deputy department
City
Rasht
Postal code
4193833697
Phone
+98 13 1321 0434
Fax
+98 13 1324 5140
Email
a_mirmansoori@gums.ac.ir
Web page address
www.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ali mirmansouri
Position
Assistant Professor
Other areas of specialty/work
Street address
Namjoo Avenue,Deputy department
City
Rasht
Postal code
4193833697
Phone
+98 13 1322 9357
Fax
+98 13 1324 5140
Email
a_mirmansoori@gums.ac.ir
Web page address
www.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ali mirmansouri
Position
Assistant Professor
Other areas of specialty/work
Street address
Namjoo Avenue,Deputy department
City
Rasht
Postal code
4193833697
Phone
+98 13 1322 9357
Fax
+98 13 1324 5140
Email
a_mirmansoori@gums.ac.ir
Web page address
www.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)