Evaluation of the effectiveness of injectable transamine administration in reducing the volume of bleeding in open trans-vesicular prostatectomy in patients with benign prostatic hyperplasia
Determination of hemoglobin level to evaluate the volume of bleeding
Design
This study was a clinical trial with a control group, with parallel groups, single blind, randomized, phase 2 per 70 patients for randomization of the Excel function rand function.
Settings and conduct
This study: Determining the effectiveness of injectable transamine administration in reducing the volume of bleeding in open transvesical prostatectomy in patients with benign prostatic hyperplasia Time: in 2021 Location: In the urology clinic of Al-Zahra Hospital affiliated to Isfahan University of Medical Sciences Done. Blinding: A type of clinical trial with a control group, with parallel groups, one-way blind so that only the participant does not know about the drug, randomized, phase 2 on 70 patients was used to randomize the rand function of Excel software. Then 35 patients in the case group underwent injectable transamine (1 gram intraoperatively and 48 hours after surgery, 3 times a day injection) and 35 patients in the control group underwent placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergoing prostatectomy.
Exclusion criteria: Use of anticoagulants such as aspirin and dipyridamole
And any history of thrombotic events
Intervention groups
The control group was treated with placebo and the case group was treated with injectable transamine (1 gram intraoperatively and 48 hours postoperatively, 3 times daily)
Main outcome variables
Hemoglobin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211121053127N1
Registration date:2021-12-21, 1400/09/30
Registration timing:prospective
Last update:2021-12-21, 1400/09/30
Update count:0
Registration date
2021-12-21, 1400/09/30
Registrant information
Name
Sina Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3796 2730
Email address
sina.mhmd1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of injectable transamine administration in reducing the volume of bleeding in open trans-vesicular prostatectomy in patients with benign prostatic hyperplasia
Public title
Efficacy of injectable transamine in patients with benign prostatic hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing Prostatectomy
Patients who are willing to participate in the study
Exclusion criteria:
Use of anticoagulants such as aspirin and dipyridamole
Prothrombin time and partial thromboplastin time are high for whatever reason
Any history of thrombotic events
History of bleeding disorders
Chronic kidney disease (serum creatinine greater than 180 micromoles per liter).
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be performed blindly with a simple randomization method using Excel software. Random function of Excel software based on patient file number will be used for randomization. Patients with benign prostatic hyperplasia entered the Excel program based on the file number and were divided into case and control groups based on the random button. There were two groups of 35 people in total. By entering the file number in Excel program, then the random number is selected from the data analysis command. This study has 2 groups that can be numbered from 1 to 2, respectively. We also want 35 people in each group. As a result, sequences 1 to 2 should be repeated 35 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 35 for repeating the sequence. In this way, 70 units will be produced.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the patient did not know whether she was in the injectable transamine group or in the placebo group. In the placebo group, distilled water or normal saline is injected instead of medicine Which is similar in shape, color, state, smell and in every way, similar to medicine
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-08-13, 1400/05/22
Ethics committee reference number
IR.MUI.MED.REC.1400.374
Health conditions studied
1
Description of health condition studied
Benign prostate enlargement
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate
Primary outcomes
1
Description
Bleeding volume
Timepoint
24 hours after surgery
Method of measurement
The amount of ml of blood removed from the patient's body
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injectable transamine * Quantity: (1 gram injection during surgery and 48 hours after surgery, 3 times a day injection) After induction of anesthesia, transamine 10 mg per kg will be infused for 10 minutes * Content: Transamine * Duration of treatment: 48 hours after surgery * Chemical composition: Pay attention to the drug leaflet in the box. * Consumption dose: 1 gram * How to use: injection * Manufacturer: Razi
Category
Treatment - Drugs
2
Description
Control group: Plasibo (In the placebo group, distilled water or normal saline is injected instead of medicine.) 1 gram of injection during the operation and 48 hours after the operation, 3 times a day injection * Content: Plasibo in terms of color, shape, volume, condition, odor. ... is similar to the main drug * Duration of treatment: 48 hours after surgery ** Dosage: 1 gram * How to use: injection * Manufacturer: Razi
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Educational and Medical Center
Full name of responsible person
Mehrdad Mohammadi sichani
Street address
Al-Zahra Educational and Medical Center, Sofeh Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
M_mohammadi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou Javanmardi
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
reaserch@mui.med.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
20
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
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Mohammadi sichani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Al-Zahra Educational and Medical Center, Sofeh Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
M_mohammadi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Mohammadi sichani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Al-Zahra Educational and Medical Center, Sofeh Boulevard
City
Isfahan
Province
Isfehan
Postal code
alzahra@mui.ac.ir
Phone
+98 31 3620 2020
Email
M_mohammadi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sina
Position
Professional medical doctoral student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Al-Zahra Educational and Medical Center, Sofeh Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Sina.mhmd1374@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