Evaluation of Therapeutic Effect of Tranexamic Acid Infusion on Reducing Blood loss during Neurosurgery in Traumatic Brain Injury Patients with Subdural and Epidural Hemorrhage Referred to Golestan Hospital in Ahwaz
Aim of this study is determining the therapeutic effects of intravenous administration of TXA in reducing the amount of intraoperative bleeding head during injury in patients with subdural and epidural hemorrhage bleeding. Participants should be over 18 years, and 8 hours after the accident to the emergency room is reached. Also do not have external bleeding skull, such as intra-abdominal hemorrhage. If a woman was pregnant and Hematuria occurred and anticoagulant drugs and aspirin have been used, they excluded from study. The study population were patients that were admitted to Golestan hospital in Ahvaz and ntracranial hemorrhage and subdural and epidural necessity to perform neurosurgery on clinical status is certified by neurosurgeons review.Sample size was 40 patients. The intervention group will receive a package containing four vials of 500 mg TXA or placebo and two sterile syringe size 21.The drug is administered as a loading dose (1g TXA added added to 100 ml of 0.9% normal saline and intravenous infusion over 10 minutes) and the maintenance dose (1 g TXT added to 500 ml of 0.9% normal saline and intravenous infusion over 8 hours) were administered by nurses. Control group will receive normal saline 0.9% instead of drug in same conditions. Injector and staff nurses in emergency medicine do not know anything about drug and placebo pocket.The primary outcome is determining amount of bleeding during surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031027003N1
Registration date:2016-08-04, 1395/05/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-04, 1395/05/14
Registrant information
Name
Pouya Ebrhimi
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 2052
Email address
ebrahimi.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Therapeutic Effect of Tranexamic Acid Infusion on Reducing Blood loss during Neurosurgery in Traumatic Brain Injury Patients with Subdural and Epidural Hemorrhage Referred to Golestan Hospital in Ahwaz
Public title
Evaluation of therapeutic effect of Tranexamic Acidinfusion during neurosurgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : age is over 18 years old; -in- eight hours after the accident to the emergency room Golestan is reached; trauma to the head and bleeding intracranial subdural and epidural on a CT scan of the brain; absence of significant cranial bleeding such as intra-abdominal hemorrhage; absence of fracture or deformity of limbs; absence of subarachnoid hemorrhage; absence of hematuria; not known coagulopathy; necessity to perform neurosurgery on clinical status and terms of neurosurgeons. Exclusion criteria : The proof of the existence of pregnancy; The presence of intracranial hemorrhage or subdural and epidural hematoma , along with the ddition; The need to FFP transfusion or injection solid; hematuria; The presence of subarachnoid hemorrhage; anticoagulant drugs and aspirin.
The intervention group will receive a package containing four vials of 500 mg TXA or placebo and two sterile syringe size 21.The drug is administered as a loading dose ( 1g TXA added to 100 ml of 0.9% normal saline and intravenous infusion over 10 minutes) and the maintenance dose (1 g TXT added to 500 ml of 0.9% normal saline and intravenous infusion over 8 hours) will be administered by nurses.
Category
Treatment - Drugs
2
Description
The control group will receive a package containing four vials of 500 mg placebo and two sterile syringe size 21.The drug is administered as a loading dose ( 1g Normal saline 0.9% added to 100 ml of 0.9% normal saline and intravenous infusion over 10 minutes) and the maintenance dose (1 g Normal saline 0.9% added to 500 ml of 0.9% normal saline and intravenous infusion over 8 hours) will be administered by nurses.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Javad Mozafari
Street address
Golestan blvd - Golestan hospital - Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Javad Mozafari
Street address
Golestan Blvd, Golestan hospital
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jondishapour 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
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Javad Mozafari
Position
Doctor of Philosophy
Other areas of specialty/work
Street address
Golestan Blvd, Golestan hospital
City
Ahvaz
Postal code
Phone
+61 3 3374 3079
Fax
Email
Mozafari.taha@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Javad Mozafari
Position
Doctor of Philosophy
Other areas of specialty/work
Street address
Golestan Blvd, Golestan hospital
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
Mozafari.taha@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Pouya Ebrahimi
Position
Student of Doctor of Philosophy
Other areas of specialty/work
Street address
Golestan Blvd, Golestan hospital
City
Ahvaz
Postal code
Phone
00
Fax
Email
Pouyaebrahimi1992@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)