In this study the effect of Tranexamic Acid on conservative treatment of Epidural Hematoma in traumatic patients will be discussed. This study rondomized- single blind- without the use of a placebo and a single central will be done. In two parallel groups of 50 cases and 50 control men and women aged 18 to 75 years with diagnosis of Epidural Hematoma (with no associated sever traumatic injuries) in Emam Reza Hospital in Tabriz had been hospitalized and do not require to surgical intervention, is selected. The intervention group receive 1 g ampul Tranexamic Acid as loading dose and then 1 g every 8 hours for two days, but control group receive standard treatment of Epidural Hematoma without the use of Tranexamic Acid or placebo.
After two days, Spiral Brain CT Scan is performed for all patients and the two groups for some parameters such as the rate of change in Epidural Hematoma diameter, level of consciousness and the rate of need for surgery before and after intervention will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040915657N1
Registration date:2014-04-09, 1393/01/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-09, 1393/01/20
Registrant information
Name
Azad Mohamadzade
Name of organization / entity
Rezident of Neurosurgery
Country
Iran (Islamic Republic of)
Phone
+98 41 1670 7183
Email address
samadimotlagh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Tranexamic Acid on conservative treatment of Epidural Hematoma in traumatic patients
Public title
Effect of Tranexamic ََََAcid on treatment of Epidural Hematoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Head trauma; GCS=15; Epidural hematoma with maximum diameter of 1 cm; Age 18-75 years old; Informed consent to participate in research
Exclusion criteria: GCS less than or equal to 13; Require surgery to evacuate the hematoma; History of anticoagulation therapy; History of head trauma; Occipital hematoma; Multiple trauma; Mid line shift; History of internal disease; age under 18 and older than 75 years old; During lactation and pregnancy
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayejan, Iran
City
Tabriz
Postal code
5155895164
Approval date
2013-10-12, 1392/07/20
Ethics committee reference number
92105
Health conditions studied
1
Description of health condition studied
Epidural Hematoma
ICD-10 code
S06.4
ICD-10 code description
Epidural haemorrhage
Primary outcomes
1
Description
Maintain or reduce of Epidural Hematoma diameter after intervention
Timepoint
Before intervention and 48 hours after intervention
Method of measurement
Brain CT Scan and measurment of the maximum diameter of the Epidural Hematoma with Millimetrs
2
Description
The rate of change of level of consciousness
Timepoint
At admission and 48 hours after intervention
Method of measurement
Glasgow Coma Score (GCS)
3
Description
The approximate volume of epidural hematoma
Timepoint
At admission and 48 hours after intervention
Method of measurement
Brain CT Scan and measurment of the maximum volume of the Epidural Hematoma with Milliliters
Secondary outcomes
empty
Intervention groups
1
Description
Ampul Tranexamic Acid,1 g as loading dose and then 1 g every 8 Hours in intervention group for two days
Category
Treatment - Drugs
2
Description
In the control group at two days after the trauma, Tranexamic Acid or placebo was not used.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Azad Mohamadzade, MD
Street address
Imam Reza Hospital, Daneshgah Avenue, Tabriz, East Azarbayejan, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azad Mohamadzade, MD
Street address
Neurosurgery department office, Imam Reza Hospital, Daneshgah Avenue, Tabriz, East Azarbayejan, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Azad Mohamadzade, MD
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
Neurosurgery department office, Imam Reza Hospital, Daneshgah Avenue, Tabriz, East Azarbayejan, Iran
City
Tabriz
Postal code
5155895164
Phone
+98 41 1670 7183
Fax
Email
mamazad1975@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Samadimotlagh, MD
Position
Assistant Professor of Neurosurgery
Other areas of specialty/work
Street address
Neurosurgery department office, Imam Reza Hospital, Daneshgah Avenue, Tabriz, East Azarbayejan, Iran
City
Tabriz
Postal code
Phone
+98 41 1334 0830
Fax
Email
samadi-motlagh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azad Mohamadzade, MD
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
Neurosurgery department office, Imam Reza Hospital, Daneshgah Avenue, Tabriz, East Azarbayejan, Iran
City
Tabriz
Postal code
5155895164
Phone
+98 41 1670 7183
Fax
Email
mamazad1975@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)