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Comparing intravenous infusion of Tranexamic Acid to prevent the progression of cerebral hemorrhage in patients with traumatic brain injury with placebo

Protocol summary

Summary
Due to high incidence of head trauma and its complications (epidural hematoma, subdural hematoma, intracerebral hemorrhage, and intraventricular hemorrhage), this study aims to examine the effect of Tranexamic acid compared to the placebo in reducing development of brain hemorrhage. The other purposes of this study include reducing the number of days of hospitalization at Intensive Care Unit (ICU), and reduction of mortality rate of traumatic brain hemorrhage. All over-18-year-old patients with the above mentioned bleeding in recent 8 hours are considered in this study after obtaining consent from the patient or his legal guardian. This single-center study is conducted at emergency department of Shahid Rahnamoun Hospital. This study is done on 50 patients, including two 25-member groups that receive drug and placebo in a double-blind and randomized manner. Tranexamic acid is prescribed at a dose of 1g/500ml of normal saline by intravenous infusion. Hemorrhage volume is compared in CT scan of admission time and after 24 hours. The main outcome variables are blood volume, the number of days of ICU care, and the mortality rate (in case of death in the first seven days). To make the study blind, at the beginning of the shift, the drug and placebo are coded and injected in the same number, shape and volume syringe, using the table of random numbers. Patients and researcher are unaware of the content of the injection. because of anti-fibrinolytic and partial anti-inflammatory effects of Tranexamic acid, it is expected that this drug can reduce the cerebral hemorrhage progression.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090423890N1
Registration date: 2015-11-21, 1394/08/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-21, 1394/08/30
Registrant information
Name
Fatemeh Modjallal Najjar
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3823 5055
Email address
fmodjallal@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadughi University of Medical Sciences of Yazd
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing intravenous infusion of Tranexamic Acid to prevent the progression of cerebral hemorrhage in patients with traumatic brain injury with placebo
Public title
the effect of tranexamic acid on cerebral hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:1) The age above 18 years old 2) The existence of hemorrhage in brain CT scan including subdural hematoma, epidural hematoma ,intra cerebral hemorrhage and intraventricular hemorrhage 3) less than 8 hours passed from trauma 4) The absence of coagulopathy Exclusion criteria: 1) Performing craniotomy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yazd Shahid Sadughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Square
City
Yazd
Postal code
8916978477
Approval date
2014-10-07, 1393/07/15
Ethics committee reference number
IR.SSU.MEDICINE.REC.1393.31

Health conditions studied

1

Description of health condition studied
Head injury
ICD-10 code
S06.3 - S0
ICD-10 code description
traumatic intracerebral haemorrhage , Epidural haemorrhage Extradural haemorrhage (traumatic), Traumatic subdural haemorrhage

Primary outcomes

1

Description
brain hemorrhage volume
Timepoint
Before intervention and 24 hours after intervention
Method of measurement
Volume in ml of blood in the brain CT scan on the hospital's network. It calculate by multiplying the maximum length in maximum width in number of cuts of hemorrhage in centimeter divided by the 2,and registering on designed form

Secondary outcomes

1

Description
The number of days of hospitalization in the intensive care unit
Timepoint
From admission of the patient until transmitting him/her from the ICU to the ward.
Method of measurement
Counting the number of days from entry and exit register in intensive care unite

2

Description
Died in the first seven days of hospitalization
Timepoint
Seven days after hospitalization
Method of measurement
Using the registry of death in hospital

Intervention groups

1

Description
Intervention 1: Tranexamic acid 500 mg per 5 ml ampule of Caspian Tamin pharmaceutical company intravenous infusion at a single dose of 1 gr in 8 hours from trauma
Category
Treatment - Drugs

2

Description
Intervention 2: Intravenous infusion of 10 cc Normal Saline
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Dr. Rahnamoon Hospital
Full name of responsible person
Fatemeh Modjallal Najjar
Street address
Shahid Dr. Rahnamoon Hospital, Farrokhi St.
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amir Houshang Mehrparvar
Street address
Vice chancellor for research, Shahid Sadoughi University of Medical Science, Shahid Bahonar square
City
Yazd
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, Shahid Sadoughi 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
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Fatemeh Modjallal Najjar
Position
Medical Doctor/Emergency Medicine Resident
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Sq.
City
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 358235055
Fax
Email
fmojallal@ssu.ac.ir,fmodjallal@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mehdi Bagherabadi
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Science, Shahid Bahonar Sq.
City
Yazd
Postal code
89195-741
Phone
+98 358261158
Fax
Email
Mehdi.bagherabadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Fatemeh Modjallal Najjar
Position
Medical Doctor , Emergency Medicine Resident
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Sq.
City
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3823 5055
Fax
Email
fmodjallal@yahoo.com,fmodjallal@ssu.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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