IRCT | The effect of vitamin C administration on the Consumption of blood products in patients undergoing open heart surgery in two groups of tranexamine and vitC+tranexamine (randomized clinical trial)

Protocol summary

Study aim: The effect of vitamin C on the Consumption of blood products in patients undergoing open heart surgery
Design: clinical trial with control group, Double-blind, randomized phase 2 on 120 cardiac surgery patients computer randomization table was used.
Settings and conduct: The place of study is Sayyad Shirazi Medical Education Center, Gorgan. Patients will have informed consent. This study is double-blind, the patient and the patient assessor will not know the type of intervention, and only the specialist responsible for the injection will know about the drug content based on the code inserted on the serum.
Participants/Inclusion and exclusion criteria: Entry criteria: age 30 to 80 years, EF more than 30%, first heart surgery, written informed consent, no history of drug sensitivity,Absence of coagulation disorder Exclusion criteria:Non-cooperation to continue participating in the study
Intervention groups: Tranexamic acid intravenous alone and combined Tranexamic acid with vitamin C
Main outcome variables: Measurement of blood loss during and after surgery; Measuring the use of blood products (cell packs, platelets, fresh frozen blood, etc.) during and after surgery; Measurement of hemoglobin drop rate after surgery; Measurement of length of stay in ICU and hospital

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20230607058400N1

Registration date: 2023-06-13, 1402/03/23

Registration timing: prospective

Last update: 2023-06-13, 1402/03/23

Update count: 0
Registration date: 2023-06-13, 1402/03/23

Registrant information: Name

sina mohajernoei

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 17 3255 8012

Email address

mohajernoei@goums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-06-22, 1402/04/01
Expected recruitment end date: 2024-06-21, 1403/04/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of vitamin C administration on the Consumption of blood products in patients undergoing open heart surgery in two groups of tranexamine and vitC+tranexamine (randomized clinical trial)

Public title: The effect of vitamin C administration on the Consumption of blood products in patients undergoing open heart surgery in two groups of tranexamine and vitC+tranexamine (randomized clinical trial)
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age between 30-80 years EF>30% BMI<26 written informed consent no history of drug sensitivity first heart surgery no history of disorders and coagulation factors hemoglobin more than 10 gr/dl

Exclusion criteria:

Dissatisfaction and willingness to participate in the study
Age: From 30 years old to 80 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor
Data analyser

Sample size

Target sample size: 120

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization is done through random blocks of four, the unit of randomization will be individual (each patient), random assignment of patients to groups is done in the order of permutations of generated random blocks. For this study, For this study, 15 blocks of 4 will be produced using the software, so that in each block, two members from group one and two members from group two are considered.

Blinding (investigator's opinion)

Double blinded

Blinding description

Patients do not know their treatment group, and the medical personnel and the patient evaluator will not know the type of drug, and only the specialist responsible for the injection based on the code inserted on the serum will know about its conten sot In this study, the outcome assessor and the data analyst also do not know the type of study

Placebo

Not used

Assignment

Parallel

Other design features

There is no unique specification

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Golestan University of Medical Sciences

Street address

International Medical Faculty, Golestan University of Medical Sciences, at the beginning of Shat Kola road, Hirkan blvd

City

Gorgan

Province

Golestan

Postal code

7451549341
Approval date: 2023-04-25, 1402/02/05
Ethics committee reference number: IR.GOUMS.REC.1402.060

Health conditions studied

1

Description of health condition studied: Haemorrhagic condition in open heart surgery
ICD-10 code: D69.9
ICD-10 code description: Hemorrhagic condition, unspecified

Primary outcomes

1

Description: Measurement of blood loss during and after surgery
Timepoint: at Hour 0, 2, 4, 6, 8, 10, 12
Method of measurement: visual estimation of blood loss in bottles

Secondary outcomes

1

Description: Measuring length of stay in ICU
Timepoint: Days of hospitalization in the ICU
Method of measurement: number of days

2

Description: Measuring length of stay in hospital
Timepoint: Days of hospitalization in hospital
Method of measurement: number of days

3

Description: Measuring the amount of hemoglobin drop
Timepoint: after surgery
Method of measurement: blood test

Intervention groups

1

Description: Intervention group: transamine injection alone 50Mg/kg bolus before surgical incision (Iran. Co Pharmaceutical Tamin Caspian®, Tranexip ) Half an hour before the surgery, the patient will be infused with 2 grams of vitamin C ampoule along with 100 cc of normal saline serum (Daroupakhsh Factory-Iran-Tehran) and then 1000 mg of vitamin C will be given every day for the first 4 days.
Category: Treatment - Drugs

2

Description: Control group: transamine injection alone 50Mg/kg bolus before surgical incision (Iran. Co Pharmaceutical Tamin Caspian®, Tranexip )
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Sayyad Shirazi Medical Education Center

Full name of responsible person

Fozieh Bakhsha

Street address

Sayyad Shirazi Blvd

City

Gorgan

Province

Golestan

Postal code

4917867439

Phone

+98 17 3220 2154

Email

infosayyad@goums.ac.ir

1

Sponsor: Name of organization / entity

Gorgan University of Medical Sciences

Full name of responsible person

Narges Beigom Mirbehbahani

Street address

Vice Chancellor for research of Medical Sciences, Golestan University of Medical Sciences, at the beginning of Shat Kola road, Hirkan blvd

City

Gorgan

Province

Golestan

Postal code

7451549341

Phone

+98 17 3242 3630

Email

n.mirbehbahani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Gorgan 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

Gorgan University of Medical Sciences

Full name of responsible person

Fozieh Bakhsha

Position

instructor faculty member

Latest degree

Master

Other areas of specialty/work

Anesthesiology

Street address

Golestan University of Medical Sciences, at the beginning of Shat Kola road, Hirkan blvd

City

Gorgan

Province

Golestan

Postal code

7451549341

Phone

+98 17 3245 0663

Email

bakhsha_fo@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Gorgan University of Medical Sciences

Full name of responsible person

Fozieh Bakhsha

Position

instructor faculty member

Latest degree

Master

Other areas of specialty/work

Anesthesiology

Street address

Golestan University of Medical Sciences, at the beginning of Shat Kola road, Hirkan blvd

City

Gorgan

Province

Golestan

Postal code

7451549341

Phone

+98 17 3245 0663

Email

bakhsha_fo@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Gorgan University of Medical Sciences

Full name of responsible person

Fozieh Bakhsha

Position

instructor faculty member

Latest degree

Master

Other areas of specialty/work

Anesthesiology

Street address

Golestan University of Medical Sciences, at the beginning of Shat Kola road, Hirkan blvd

City

Gorgan

Province

Golestan

Postal code

4934174515

Phone

+98 17 3245 0663

Email

bakhsha_fo@yahoo.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

The effect of vitamin C administration on the Consumption of blood products in patients undergoing open heart surgery in two groups of tranexamine and vitC+tranexamine (randomized clinical trial)