Evaluation of intravenous Tranexamic acid effect on blood loss during and post transurethral resection of prostate (TURP) surgery: A Randomized Placebo-controlled Trial
The aim of study is to evaluate the effect of intravenous Tranexamic acid on bleeding, during and/or post TURP. Patients with BPH that are 50-80 years old and categorized in class 1 -3 ASA and no contraindication for TURP will be included in this study. Patients randomly will be divided into two groups. The first group receives 500cc of the Tranexamic acid and second group (control group) receives Normal saline solely (placebo). Prostate weight, Hb and Hct will be measured before the surgery. During the surgery, if it is necessary, packed cell will be infused. At the end of the surgery, surgeon satisfaction, infused serum or blood volume and duration of surgery (minute) will be recorded. After 6 hrs. Hb, Hct and probable side effects will be evaluated. Then the results in both groups will be compared by utilizing SPSS 23 software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030111822N5
Registration date:2017-06-06, 1396/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Behrooz Karkhanei
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0574
Email address
karkhanei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-09-01, 1393/06/10
Expected recruitment end date
2015-04-30, 1394/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intravenous Tranexamic acid effect on blood loss during and post transurethral resection of prostate (TURP) surgery: A Randomized Placebo-controlled Trial
Public title
Tranexamic Acid and its effect on TURP operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with BPH; that are 50-80 years old. their prostate gland weight was measured by sonography. measuring of Hb, Hct before the surgery. ASA≤II. Exclusion criteria: patient disagreement.renal dysfunction .color vision dysfunction .coagulopathy. IHD or arrhythmia .anticoagulant consumption, CVA. Hx of tranexamic acid allergy. Hx of PTE or DVT.
Age
From 50 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
A Randomized Placebo-controlled Trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Human Subject Review Board, Hamadan University of Medical Sciences
Street address
Shaheed Famideh Street, Hamadan University Of Medical Sciences
City
Hamadan
Postal code
6517838695
Approval date
2014-01-20, 1392/10/30
Ethics committee reference number
P/16/35/9/3563
Health conditions studied
1
Description of health condition studied
benign hypertrophy of prostate
ICD-10 code
N40
ICD-10 code description
Hypertrophy (benign) of prostate
Primary outcomes
1
Description
Hct
Timepoint
before and 6hr after surgery
Method of measurement
automatic analysor.(cell count)
2
Description
Hb
Timepoint
before and 6hr after surgery
Method of measurement
automatic analysor.(cell count)
3
Description
prostate weight
Timepoint
before the surgery
Method of measurement
by sonography in mg
4
Description
duration of the surgery
Timepoint
after the surgery
Method of measurement
as soon as entering to urinary urethral until foley catheter fixation
5
Description
sergeon satisfaction
Timepoint
after the surgery
Method of measurement
surgeon opinion
6
Description
transfusion
Timepoint
after the surgery
Method of measurement
amount of unit packed cell
7
Description
serum volume during the surgery
Timepoint
after the surgery
Method of measurement
intake serum volume in cc
Secondary outcomes
1
Description
Nausea
Timepoint
6 hr after surgery
Method of measurement
Ask the patient
2
Description
Seizure
Timepoint
6 hr after surgery
Method of measurement
Ask the patient
3
Description
Vomiting
Timepoint
6 hr after surgery
Method of measurement
Ask the patient
Intervention groups
1
Description
as starting the serum therapy for case group, the 500cc Tranexamic acid in 500cc ringer serum with 1mg/ml concentration and maximum flow 100mg/min
Category
Prevention
2
Description
transfusion of 500cc ringer serum solely
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Behruz Karkhanei
Street address
Shahid Beheshti Hospital, Eram Blvd., Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Hamadan University of Medical Science
Full name of responsible person
Ahmad Tavilani
Street address
Hamadan University of Medical Sciences, Vice chancellor for Research and Technology, Shaheed Fahmideh St
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology, Hamadan University of Medical Science
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
Hamadan University of Medical sciences
Full name of responsible person
Behrooz Karkhanei
Position
MD. Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Medicine faculty, Hamadan University of Medical sciences, Shaheed Fahmideh St.
City
Hamadan
Postal code
3371565179
Phone
+98 81 3838 0574
Fax
+98 83 81035
Email
karkhanei@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Behrooz Karkhanei
Position
MD. Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Medicine faculty, Hamadan University of Medical sciences, Shaheed Fahmideh St.
City
Hamadan
Postal code
3371565179
Phone
+98 81 3838 0574
Fax
+98 83 81035
Email
karkhanei@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Masume Bayat
Position
Medical student
Other areas of specialty/work
Street address
Medicine faculty, Hamadan University of Medical sciences, Shaheed Fahmideh St.
City
Hamadan
Postal code
Phone
00
Fax
Email
dr.bayat2011@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)