Investigating the effect of Tranexamic acid acid drug in the prime solution of the cardiopulmonary bypass system on the amount of bleeding after surgery in open heart surgeries.
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Protocol summary
This study is conducted in a double-blind manner and 70 patients are randomly divided into two control and intervention groups by the software.
This study is conducted in a double-blind manner and 60 patients are randomly divided into two control and intervention groups by the software.
This study is conducted in a double-blind manner and 7060 patients are randomly divided into two control and intervention groups by the software.
این مطالعه بصورت دو سو کور انجام میگیرد و 70 بیمار به طور تصادفی توسط نرم افزار به دو گروه کنترل و مداخله تقسیم میشوند.
این مطالعه بصورت دو سو کور انجام میگیرد و 60 بیمار به طور تصادفی توسط نرم افزار به دو گروه کنترل و مداخله تقسیم میشوند.
این مطالعه بصورت دو سو کور انجام میگیرد و 7060 بیمار به طور تصادفی توسط نرم افزار به دو گروه کنترل و مداخله تقسیم میشوند.
People with coronary artery problems and heart valve problems who need surgery and undergo cardiopulmonary bypass pump surgery.
People older than 18 years
Patients who have coagulation problems before the operation are not included in the study.
Patients with thrombocytopenia or platelet count less than 100,000/ml are not included in the study.
Patients whose CPB time is more than 90 minutes are not included in the study.
Patients with hemoglobin lower than 10 mg/dL are not included in the study
People with kidney failure
Hypersensitivity to tranexamic acid
People with coronary artery problems and heart valve problems who need surgery and undergo cardiopulmonary bypass pump surgery.
People older than 18 years
Patients who have coagulation problems before the operation are not included in the study.
platelet count less than 100,000/ml are not included in the study.
Patients whose CPB time is more than 90 minutes are not included in the study.
Patients with hemoglobin lower than 10 mg/dL are not included in the study
People with kidney failure
Hypersensitivity to tranexamic acid
People with coronary artery problems and heart valve problems who need surgery and undergo cardiopulmonary bypass pump surgery. People older than 18 years Patients who have coagulation problems before the operation are not included in the study. Patients with thrombocytopenia or platelet count less than 100,000/ml are not included in the study. Patients whose CPB time is more than 90 minutes are not included in the study. Patients with hemoglobin lower than 10 mg/dL are not included in the study People with kidney failure Hypersensitivity to tranexamic acid
افراد دارای مشکلات عروق کرونر و مشکلات دریچه قلبی که نیاز به جراحی دارند و تحت پمپ بای پس قلبی ریوی جراحی میشوند.
افراد بزرگتر از 18 سال
بیمارانی که قبل از عمل دارای مشکلات انعقادی باشند به مطالعه وارد نمی شوند.
بیماران دارای ترومبوسایتوپنی و یا تعداد پلاکت کمتر از 100 هزار در میلی لیتر به مطالعه وارد نمی شوند
بیمارانی که طول مدت CPB time آنها بیشتر از 90 دقیقه باشد به مطالعه وارد نمی شوند.
بیماران دارای هموگلوبین پایین تر از 10 میلی گرم در دسی لیتر به مطالعه وارد نمی شوند
افراد دارای نارسایی کلیه یا کراتینین سرم بالاتر از 1.4 میلی گرم در دسی لیتر برای مردان و 1.2 میلی گرم در دسی لیتر برای زنان به مطالعه وارد نمی شوند
افراد دارای سابقه ترومبوز وریدی به مطالعه وارد نمی شوند
حساسیت به ترانگزامیک اسید
افراد دارای مشکلات عروق کرونر و مشکلات دریچه قلبی که نیاز به جراحی دارند و تحت پمپ بای پس قلبی ریوی جراحی میشوند.
افراد بزرگتر از 18 سال
بیمارانی که قبل از عمل دارای مشکلات انعقادی باشند به مطالعه وارد نمی شوند.
بیماران با تعداد پلاکت کمتر از 100 هزار در میلی لیتر به مطالعه وارد نمی شوند
بیمارانی که طول مدت CPB time آنها بیشتر از 90 دقیقه باشد به مطالعه وارد نمی شوند.
بیماران دارای هموگلوبین پایین تر از 10 میلی گرم در دسی لیتر به مطالعه وارد نمی شوند
افراد دارای نارسایی کلیه یا کراتینین سرم بالاتر از 1.4 میلی گرم در دسی لیتر برای مردان و 1.2 میلی گرم در دسی لیتر برای زنان به مطالعه وارد نمی شوند
افراد دارای سابقه ترومبوز وریدی به مطالعه وارد نمی شوند
حساسیت به ترانگزامیک اسید
افراد دارای مشکلات عروق کرونر و مشکلات دریچه قلبی که نیاز به جراحی دارند و تحت پمپ بای پس قلبی ریوی جراحی میشوند. افراد بزرگتر از 18 سال بیمارانی که قبل از عمل دارای مشکلات انعقادی باشند به مطالعه وارد نمی شوند. بیماران دارای ترومبوسایتوپنی و یابا تعداد پلاکت کمتر از 100 هزار در میلی لیتر به مطالعه وارد نمی شوند بیمارانی که طول مدت CPB time آنها بیشتر از 90 دقیقه باشد به مطالعه وارد نمی شوند. بیماران دارای هموگلوبین پایین تر از 10 میلی گرم در دسی لیتر به مطالعه وارد نمی شوند افراد دارای نارسایی کلیه یا کراتینین سرم بالاتر از 1.4 میلی گرم در دسی لیتر برای مردان و 1.2 میلی گرم در دسی لیتر برای زنان به مطالعه وارد نمی شوند افراد دارای سابقه ترومبوز وریدی به مطالعه وارد نمی شوند حساسیت به ترانگزامیک اسید
General information
empty
Typographical error
Typographical error
empty
Typo
Typo
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: _
Full name of responsible person - Persian: _
Street address - English: Shohaday gomnam Blvd
Street address - Persian: یزد. بلوار شهدای گمنام. پردیس علوم پزشکی. دانشکده پزشکی . دفتر تحصیلات تکمیلی
City - English: YAZD
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8915173160
Phone: +98 35 3820 3862
Fax:
Email: javad.mc.111@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahdi Hashemi
Full name of responsible person - Persian: مهدی هاشمی
Street address - English: Shohaday gomnam Blvd
Street address - Persian: یزد. بلوار شهدای گمنام. پردیس علوم پزشکی. دانشکده پزشکی . دفتر تحصیلات تکمیلی
City - English: YAZD
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8915173160
Phone: +98 35 3820 3862
Fax:
Email: javad.mc.111@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: _Mahdi Hashemi Full name of responsible person - Persian: _مهدی هاشمی Street address - English: Shohaday gomnam Blvd Street address - Persian: یزد. بلوار شهدای گمنام. پردیس علوم پزشکی. دانشکده پزشکی . دفتر تحصیلات تکمیلی City - English: YAZD City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8915173160 Phone: +98 35 3820 3862 Fax: Email: javad.mc.111@gmail.com Web page address:
Protocol summary
Study aim
Determining the effect of Tranexamic acid drug in the prime solution of the cardiopulmonary bypass system on the amount of bleeding after surgery in open heart surgeries.
Design
This study is conducted in a double-blind manner and 60 patients are randomly divided into two control and intervention groups by the software.
Settings and conduct
The study is conducted in Yazd Heart Hospital. Patients, surgeons, nurses and perfusionists are not aware of which study group the patients are in.
Participants/Inclusion and exclusion criteria
People with coronary artery problems and heart valve problems who need surgery and undergo cardiopulmonary bypass pump surgery.
People older than 18 years
Patients who have coagulation problems before the operation are not included in the study.
platelet count less than 100,000/ml are not included in the study.
Patients whose CPB time is more than 90 minutes are not included in the study.
Patients with hemoglobin lower than 10 mg/dL are not included in the study
People with kidney failure
Hypersensitivity to tranexamic acid
Intervention groups
In the prime solution of the cardiopulmonary bypass device in the intervention group, tranexamic acid drug is used. But normal saline is used in the control group.
Main outcome variables
One of the most important side effects of open heart surgery is bleeding. If the results of this study are positive regarding the reduction of bleeding, this drug can be used in the prime solution of the cardiopulmonary bypass system in heart surgeries so that the bleeding complication reaches its minimum level and the patient's hemodynamics has a more stable condition, which ultimately reduces the death rate. and reduce the mortality of patients and various complications, including cardiac tamponade, coagulation disorders, etc.
General information
Reason for update
Typographical error
Acronym
IRCT registration information
IRCT registration number:IRCT20240220061056N1
Registration date:2024-05-14, 1403/02/25
Registration timing:registered_while_recruiting
Last update:2024-07-08, 1403/04/18
Update count:1
Registration date
2024-05-14, 1403/02/25
Registrant information
Name
Javad Saeedi nia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3862
Email address
j.saeedinia@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-28, 1403/01/09
Expected recruitment end date
2024-05-29, 1403/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Tranexamic acid acid drug in the prime solution of the cardiopulmonary bypass system on the amount of bleeding after surgery in open heart surgeries.
Public title
Investigating the effect of Tranexamic acid drug in cardiopulmonary bypass device
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with coronary artery problems and heart valve problems who need surgery and undergo cardiopulmonary bypass pump surgery.
Exclusion criteria:
under of 18 years
History of seizures before surgery
History of embolism before surgery
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of allocating the samples to the two study groups will be obtained by the permutation block method and by considering blocks of size 6 using the Random Allocation software where T represents the intervention group and P represents the control group.
PTPPTT,TTPPTP,TPPPTT,TPTTPP,TTTPPP,TPPPTT,TPPPTT,PTPTTP,TTPPPT,TPPTPT
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants do not know which intervention or control group they are in.
The surgeon, nurse and perfusionist involved in the treatment process do not know which group the patient belongs to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Yazd Medical Sciences
Street address
Graduate room,medical School,shohada gomnam blvd,Yazd Town
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2023-10-11, 1402/07/19
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.185
Health conditions studied
1
Description of health condition studied
Investigating the amount of bleeding in heart surgery
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
Bleeding rate after surgery
Timepoint
24 hours after the operation
Method of measurement
chest bottle blood volume
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The use of tranexamic acid drug at a dose of 15 mg/kg as a single dose is injected into the prime solution of the cardiopulmonary bypass device before the start of cardiopulmonary bypass.
Category
Treatment - Drugs
2
Description
Control group: In the control group, only 10 cc of normal saline will be added to the prime solution of the cardiopulmonary bypass device as a placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital, Yazd
Full name of responsible person
Seyed Hossein Moshtaghion
Street address
Jomhori
City
yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 5011
Email
javad.mc.111@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahdi Hashemi
Street address
Shohaday gomnam Blvd
City
YAZD
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 3862
Email
javad.mc.111@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Seyed Hossein Moshtaghion
Position
Associate professor and anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
_
City
yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 5011
Email
javad.mc.111@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Seyed Hossein Moshtaghion
Position
Associate professor and anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
_
City
yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 5011
Email
javad.mc.111@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Seyed Hossein Moshtaghion
Position
Associate professor and anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhori Blv
City
yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 5011
Email
javad.mc.111@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available