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Studying effect of tranexamic acid plus fibrinogen on mediastinal bleeding in cardiac patients after open heart surgery

Protocol summary

Summary
Aim: The present study is a comparative analysis of the effect of tranexamic acid with fibrinogen on mediastinal bleeding after cardiac surgery. After undergoing cardiac surgery, patients with more than 200 cc/hour mediastinal bleeding are randomly divided into control and intervention groups (according to the random number table). The data related to the first group (control group) that received only 15mg/kg tranexamic acid are collected using a questionnaire. The subjects in the intervention group are injected with 15mg/kg (milligrams per kilogram) tranexamic acid plus 2g fibrinogen. Then, the length of stay in the intensive care unit (ICU), mediastinal drainage, use of blood products, intubation time in ICU, discharge conditions and mortality are registered for each subject. 40 subjects are allocated to each group. The patients who meet the following criteria are included in the study: 1) Mediastinal drainage of more than 200 cc/hour after cardiac surgery, 2) Age<70 years, 3) Ejection Fraction (EF)>30% and 4) Body Mass Index (BMI)<30. The exclusion criteria are as follows: 1) Emergency or second cardiac surgery, 2) Hemoglobin (Hb)<10, 3) Platelet count<100,000/cc and 4) Hematologic diseases. The present study is double blind, meaning that the patient and the person who fills out the questionnaire are not informed about the prescribed/unprescribed drugs.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013082714489N1
Registration date: 2014-04-07, 1393/01/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-07, 1393/01/18
Registrant information
Name
Mohammad Esmaeelzadeh
Name of organization / entity
Mashhad university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1802 2022
Email address
esmaeelzadehm901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Doctor Shahram Amini
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-07-06, 1393/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying effect of tranexamic acid plus fibrinogen on mediastinal bleeding in cardiac patients after open heart surgery
Public title
Effect of fibrinogen on bleeding after cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Mediastinal drainage of more than 200 cc/hour after cardiac surgery, 2) Age<70 years, 3) Ejection Fraction (EF)>30% and 4) Body Mass Index (BMI)<30; Exclusion criteria: 1) Emergency or second cardiac surgery, 2) Hemoglobin (Hb)<10, 3) platelet count<100,000/cc, and 4) Hematologic diseases
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The subjects are divided into control and intervention groups according to random number table.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Central building of Mashhad university of medical sciences, after Shahid Javan square, Shahid Fakoori street
City
Mashhad
Postal code
Approval date
2013-02-07, 1391/11/19
Ethics committee reference number
910249

Health conditions studied

1

Description of health condition studied
Ischemic heart diseases
ICD-10 code
I20.9
ICD-10 code description
Angina pectoris, unspecified

2

Description of health condition studied
Nonrheumatic mitral valve disorders
ICD-10 code
I34.9
ICD-10 code description
Nonrheumatic mitral valve disorders, unspecified

3

Description of health condition studied
Nonrheumatic aortic valve disorders
ICD-10 code
I35.9
ICD-10 code description
Nonrheumatic aortic valve disorders, unspecified

4

Description of health condition studied
Nonrheumatic tricuspid valve disorders
ICD-10 code
I36.9
ICD-10 code description
Nonrheumatic tricuspid valve disorders, unspecified

5

Description of health condition studied
Pulmonary valve disorders
ICD-10 code
I37.9
ICD-10 code description
Pulmonary valve disorders, unspecified

6

Description of health condition studied
Rheumatic heart diseases
ICD-10 code
I01.9
ICD-10 code description
Acute rheumatic heart disease, unspecified

Primary outcomes

1

Description
Mediastinal bleeding
Timepoint
Conducted on an hourly basis for 48 hours from the time of ICU admission after surgery (before and after the intervention)
Method of measurement
Registered in the questionnaire (cc/hour)

Secondary outcomes

1

Description
Mortality
Timepoint
Measured daily during the hospital stay before and after the intervention
Method of measurement
Registered in the questionnaire according to patients percentage until discharge

2

Description
ICU length of stay
Timepoint
The length of post-operative ICU stay before and after the intervention
Method of measurement
Registered in the questionnaire on a daily basis

3

Description
Blood product usage (fresh frozen plasma, platelets, packed cells, whole blood)
Timepoint
Registered every 4 hours for a 48 hours period, during the post-operative ICU stay (before and after the intervention)
Method of measurement
Registered in the questionnaire according to the products bag

Intervention groups

1

Description
The subjects in the intervention group are injected with 15mg/kg tranexamic acid plus 2 g(grams) fibrinogen (Haemocomplettan as the generic name). Afterwards, the length of stay in the ICU, mediastinal bleeding, use of blood products, intubation time in ICU, discharge conditions and mortality are registered for each subject. These drugs are intravenously injected in one session, immediately after mediastinal bleeding of more than 200 cc/hr. The last stage in non-responder patients is re-exploration.
Category
Treatment - Drugs

2

Description
The second group consists of control subjects who receive 15 mg/kg tranexamic acid and routine care (including blood pressure control and use of blood products according to the paraclinical findings). The last stage in non-responder patients is re-exploration.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Doctor Mohammad Esmaeelzadeh
Street address
Emam Reza square, Ebne Sina street
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad university of medical sciences
Full name of responsible person
Doctor Mohsen Tafaghodi
Street address
Ghoreishi building, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Doctor Mohammad Esmaeelzadeh
Position
Resident of anesthesiology and ICU
Other areas of specialty/work
Street address
Emam Reza hospital, Emam Reza square, Ebne sina street
City
Mashhad
Postal code
Phone
+98 51 1802 2314
Fax
Email
Esmaeilzm901@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Doctor Shahram Amini
Position
ICU fellowship, anesthesiologist
Other areas of specialty/work
Street address
Emam Reza hospital, Emam Reza square, Ebne Sina street
City
Mashhad
Postal code
Phone
+98 51 1802 2314
Fax
Email
Aminish@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Doctor Mohammad Esmaeelzadeh
Position
Resident of anesthesiology and ICU
Other areas of specialty/work
Street address
Emam Reza hospital, Emam Reza square, Ebne Sina street
City
Mashhad
Postal code
Phone
+98 51 1802 2314
Fax
Email
Esmaeilzm901@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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