assessing the effectiveness of platelet treatment in reducing bleeding during CABG surgery
Design
A double blibded single arm parallel randomised trial
Settings and conduct
this clinical trial is designed to evaluate the effect of Prophylactic Platelet infusion to reduce Bleeding after CABG in Patients who receive Plavix Drug
Participants/Inclusion and exclusion criteria
patients who need CABG surgery and we can not hold plavix tratment
Intervention groups
5 unit Platelet infusion in the intervention group
routine treatment in the control group (no platelet injection)
Main outcome variables
Bleeding amount
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200902048590N1
Registration date:2020-10-31, 1399/08/10
Registration timing:retrospective
Last update:2020-10-31, 1399/08/10
Update count:0
Registration date
2020-10-31, 1399/08/10
Registrant information
Name
hamidreza hoseinikhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2748
Email address
hoseinikhahh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-30, 1396/08/08
Expected recruitment end date
2018-04-22, 1397/02/02
Actual recruitment start date
2017-10-30, 1396/08/08
Actual recruitment end date
2017-10-30, 1396/08/08
Trial completion date
2018-04-23, 1397/02/03
Scientific title
Assessing the effect of platelet infusion in reducing hemorrhage during CABG surgery in patients under plavix treatment
Public title
Assessing the effect of platelet infusion in reducing hemorrhage during CABG surgery in patients under plavix treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Using plavix
Need for coronary artery bypass
Being unable to hold plavix
Informed consent
Exclusion criteria:
Patient's dissatisfaction and the desire to cut off cooperation
Incidence of complications
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Individually
by using Random number table
Consecutive numbers
Allocation Concealment with SNOSE (sequentially numbered, opaque, sealed envelopes.)
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the therapist and outcome assessor are unaware of the allocation
The nurse assigns the subjects to the study group into one of two groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi building,Daneshgah Ave,Ahmad Abad Blv,Mashhad,Razavi Khorasan Province,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.MUMS.MEDICAL.REC.139511
Health conditions studied
1
Description of health condition studied
بیماری عروق کرونر
ICD-10 code
T82.8
ICD-10 code description
Other specified complications of cardiac and vascular prosthetic devices, implants and grafts
Primary outcomes
1
Description
bleeding amount
Timepoint
1, 6, 12, 24, and 48 hours after surgery
Method of measurement
Assessing the amount of packed cell needed
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: platelet infusion
Category
Treatment - Drugs
2
Description
Control group: Routine treatment (NO platelet injection)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr. Seyyed Hamidreza Hosseinikhah
Street address
Imam Reza hospital,Ibne Sina street,Ahmad Abad Blv,Mahhad,Khorasan Razavi Province,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۸۷۵۶۱۱
Phone
+98 51 3501 9166
Email
hoseinikhahh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad University Of Medical Science,Azadi Square,Vakil Abad Blv,Mashhad,Khorasan Razavi Province,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9179875611
Phone
+98 51 3501 9166
Email
tafaghodim@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Seyyed Hamid Reza Hoseinikhah
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Mashhad University Of Medical Science,Azadi Square,Vakil Abad Blv,Mashhad,Khorasan Razavi Province,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9179875611
Phone
+98 51 3501 7699
Email
hoseinikhahh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Seyyed Hamidreza Hoseinikhah
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Mashhad University Of Medical Science,Azadi Square,Vakil abad Blv,Mashhad,Khorasan Razavi,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9179875611
Phone
+98 51 3501 4757
Email
hoseinikhahh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Seyyed Hamid Reza Hosseinikhah
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Mashhad University Of Medical Science,Azadi Square,Vakil abad Blv,Mashhad,Khorasan Razavi,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9179875611
Phone
+98 51 3501 8564
Email
hoseinikhahh@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Yes - There is 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
Title and more details about the data/document
The whole data can be assessed
When the data will become available and for how long
six months after the termination of the study
To whom data/document is available
researcher and analyst
Under which criteria data/document could be used
only in case of assessment and analysis for research article
From where data/document is obtainable
researcher
What processes are involved for a request to access data/document