Assessing the efficacy of Tranexamic acid versus placebo in reducing fibrinolysis, blood loss, and transfusion requirements during open prostatectomy surgery
Assessing the effect of tranexamic acid on reducing fibrinolysis, bleeding and the need for blood transfusion in open prostatectomy
Design
This is a two-arm, parallel-group, double-blind, randomized trial. َA total of 40 patients who are undergoing open prostatectomy with spinal anesthesia is recruited. Study participants are randomized to receive either tranexamic acid (10mg/kg) or normal saline solution (100cc) over 30 minutes before initiation of surgery using a randomization table. Estimated blood loss and the need for blood transfusion are recorded. Two venous blood samples (5cc) are obtained from each patient (at the beginning and at the end of the operation) to perform rotational thromboelastometry (ROTEM) analysis.
Settings and conduct
This double-blinded study is performed in Sina Hospital, Tehran, Iran. The anesthesiologist (main researcher) and patients are blinded to study allocation.
Participants/Inclusion and exclusion criteria
Male patients who are undergoing open prostatectomy
exclusion criteria: use of anticoagulant or anti-platelet medications, known history of coagulopathy, previous history of DVT or PTE
Intervention groups
Intervention group: patients receive tranexamic acid (10mg/kg) diluted in 100cc of normal saline solution over 30 minutes before initiation of surgery
placebo group: patients only receive 100cc of normal saline over 30 minutes before initiation of surgery
Main outcome variables
blood loss volume; blood transfusion; fibrinolysis in rotational thromboelastometry analysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170805035510N6
Registration date:2019-09-17, 1398/06/26
Registration timing:prospective
Last update:2019-09-17, 1398/06/26
Update count:0
Registration date
2019-09-17, 1398/06/26
Registrant information
Name
Pejman Pourfakhr
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4466 3963
Email address
pourfakhr@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the efficacy of Tranexamic acid versus placebo in reducing fibrinolysis, blood loss, and transfusion requirements during open prostatectomy surgery
Public title
Application of Tranexamic acid in prostatectomy surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are undergoing open prostatectomy surgery with spinal anesthesia
Exclusion criteria:
Administration of general anesthesia (patients who do not consent for spinal anesthesia or failure of spinal anesthesia)
Previous history of deep vein thrombosis, pulmonary emboli or myocardial infarction
Patients who receive packed red blood cells within one week of surgery
Hemoglobin level lower than 10 mg/dl
Use of anticoagulant drugs (Warfarin, Heparin, etc) within one month of surgery
Use of antiplatete medications (Clopidogrel, Aspirin, etc) within one month of surgery
Previous diagnosis of coagulopathy
Patients who are assigned to the American Society of Anesthesiologists physical status classification of III or higher
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed by employing the simple randomization method and random number table. Patients are allocated into two groups (20 patients in each group).
Blinding (investigator's opinion)
Double blinded
Blinding description
The main researcher (anesthesiologist) and the patients are unaware of study allocation. A nurse anesthetist (who is not involved in the study) receives the randomization table in a sealed envelope and allocates patients to study group according to the table. Rotational thromboelastometry (ROTEM) analyses are performed by the anesthesiologist and obtained data are entered into Statistical Package for the Social Sciences (SPSS) software. All the clinical assessments, including blood loss estimation and adminstiring packed red blood cells are performed by the main researcher who is blinded to study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences and Health services
Street address
Tehran University of Medical Sciences, Central Building, Ghods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-07-25, 1397/05/03
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.287
Health conditions studied
1
Description of health condition studied
Fibrinolysis and bleeding during open prostatectomy
ICD-10 code
T81.0
ICD-10 code description
Haemorrhage and haematoma complicating a procedure, not elsewhere classified
Primary outcomes
1
Description
intraoperative blood loss
Timepoint
At the end of surgery
Method of measurement
The volume of blood absorbed by surgical gauze was estimated using Gauze Visual Analogue method. The mentioned figures plus the amount of blood in the surgical suction pump was considered as the total amount of intraoperative blood loss
2
Description
transfusion of packed red blood cell
Timepoint
During the surgery
Method of measurement
the number of transfused PC were recorded
Secondary outcomes
1
Description
fibrinolysis (based on rotational thromboelastometry analysis)
Timepoint
before intervention and at the end of surgery
Method of measurement
rotational thromboelastometry (ROTEM)
Intervention groups
1
Description
Intervention group: Patients receive tranexamic acid (10mg/kg) diluted in normal saline (100cc) over 30 minutes before initiation of surgery
Category
Treatment - Drugs
2
Description
Control group: patients receive normal saline (100cc) over 30 minutes before initiation of surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Pejman Pourfakhr
Street address
Sina hospital, Imam Khomeini street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir
Web page address
http://en.sinaih.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Pejman Pourfakhr
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1848836578
Phone
+98 21 4466 3963
Fax
+98 21 4466 3963
Email
pourfakhr@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pejman Pourfakhr
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1848836578
Phone
+98 21 4466 3963
Fax
+98 21 4466 3963
Email
pourfakhr@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamadreza Neishaboury
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1848836578
Phone
+98 21 4427 2306
Email
m.neishaboury@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Considering the limited number of open prostatectomies which are performed in our hospital, there is a concern regarding our participants' privacy and whether were are able to maintain patients' anonymity.