Determining the effect of pentoxifylline on increasing the flexibility of red blood cells in patients undergoing cardiopulmonary bypass
Design
Due to the fact that there are no exact studies and the necessary information to estimate the sample size. Individuals in a pilot study consisting of 15 people in each group and using the information of this pilot study, the sample size will be estimated and announced.
Settings and conduct
The statistical population is all patients who will undergo open heart surgery in Kosar Hospital in Semnan
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergoing open heart surgery, absence of vascular disease, patients with no hemoglobinopathy or disorder that causes erythrocyte lysis, patients with no contraindications to pentoxifylline. To be.
Intervention groups
Patients enrolled in the study will be divided into two groups using a table of random numbers based on a computer random sequence. The first group will take 400 mg of pentoxifylline and the second group will take a placebo every 8 hours for three days before surgery.
Main outcome variables
Determining the effect of pentoxifylline on peripheral blood smear changes after surgery,Determining the effect of pentoxifylline on hemoglobinuria after surgery,Determining the effect of pentoxifylline on hemoglobin after surgery,Determining the effect of pentoxifylline on hematuria after surgery,Determining the effect of pentoxifylline on serum bilirubin after surgery,Determining the effect of pentoxifylline on the percentage of reticulocytes after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210420051018N1
Registration date:2021-11-15, 1400/08/24
Registration timing:prospective
Last update:2021-11-15, 1400/08/24
Update count:0
Registration date
2021-11-15, 1400/08/24
Registrant information
Name
mohammad forozeshfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
mff45@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-30, 1400/09/09
Expected recruitment end date
2022-04-29, 1401/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of pentoxifylline on the prevention of erythrocyte lysis in cardiac surgery patients undergoing cardiopulmonary bypass
Public title
Evaluation of the effect of pentoxifylline on the prevention of erythrocyte lysis in cardiac surgery patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing open heart surgery
Absence of blood vessel disease
Patients who do not have hemoglobinopathy or a disorder that causes red blood cell lysis
Patients who do not have a contraindication to pentoxifylline.
Exclusion criteria:
Patients with renal and hepatic insufficiency
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
The study will be conducted as a clinical trial with an equivalent group and with before and after measurements. Using a table of random numbers based on computer random sequence, they will be divided into two groups. They will take it every 8 hours before the surgery
Blinding (investigator's opinion)
Single blinded
Blinding description
n this study, after selecting the sample and describing the objectives of the study, participants (patients) will be randomly divided into two groups. A separate code is defined for each person and the participants will be given the main drug and placebo without knowing which group they are in. Blinding will inform.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Kowsar educational and research center,Golestan town.
City
Semnan
Province
Semnan
Postal code
35198-99951
Approval date
2021-07-26, 1400/05/04
Ethics committee reference number
IR.SEMUMS.REC.1400.104
Health conditions studied
1
Description of health condition studied
All patients undergo open heart surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determination of the effect of pentoxifylline on erythrocyte flexibility in patients undergoing cardiopulmonary bypass
Timepoint
400 mg pentoxifylline tablets every 8 hours for three days before heart surgery
Method of measurement
check list
2
Description
Determining the effect of pentoxifylline on peripheral blood smear changes after surgery
Timepoint
Before surgery and 24 hours after surgery
Method of measurement
Laboratory tests
3
Description
Determining the effect of pentoxifylline on hemoglobinuria after surgery
Timepoint
Before surgery and 24 hours after surgery
Method of measurement
Laboratory tests
4
Description
Determining the effect of pentoxifylline on serum bilirubin after surgery
Timepoint
Before surgery and 24 hours after surgery
Method of measurement
Laboratory tests
5
Description
Determining the effect of pentoxifylline on the percentage of reticulocytes after surgery
Timepoint
Before surgery and 24 hours and 48 hours after surgery
Method of measurement
Laboratory tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Candidates who are candidates for cardiopulmonary bypass will take 400 mg pentoxifylline tablets made by Hakim Pharmaceutical Company every 8 hours for three days before surgery.
Category
Treatment - Drugs
2
Description
Control group: Candidates who will be candidates for cardiopulmonary bypass will take a placebo every 8 hours from the three days before surgery, much like the drug studied by Hakim Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital, Semnan
Full name of responsible person
Mohammad Foroozeh Fard
Street address
Kowsar educational and research center,Golestan town.
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3343 7837
Email
mff45@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Foroozeh Fard
Street address
Kowsar educational, research and treatment center,Golestan town.
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3343 7837
Email
mff45@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Foroozeh Fard
Position
full Profesor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kowsar educational, research and treatment center,Golestan town.
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3343 7837
Email
mff45@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Foroozeh Fard
Position
full Profesor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kowsar educational, research and treatment center,Golestan town.
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3343 7837
Email
mff45@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Foroozeh Fard
Position
full Profesor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kowsar educational, research and treatment center,Golestan town.
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3343 7837
Email
mff45@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data of this research will be available to all researchers working in academic and scientific institutions
Under which criteria data/document could be used
They can request this email for information :mff45@yahoo.com
From where data/document is obtainable
They can request this email for information :mff45@yahoo.com
What processes are involved for a request to access data/document
They can request this email for information :mff45@yahoo.com