Evaluation of therapeutic effect of Tranexamic Acid infusion on reducing blood loss during neurosurgery in Traumatic Brain injury patients with intraparenchymal hemorrhage
Aim of this triple blind clinical trial is determining the therapeutic effects of intravenous administration of TXA in reducing the amount of intraoperative bleeding during surgery in head trauma patients with Intraparenchymal hemorrhage. Participants should be over 18 years, and should attend to the emergency room during first 8 hours after the accident. Also they shouldn't have extracranial bleeding, such as intra-abdominal hemorrhage. Pregnancy, hematuria and usage of anticoagulants and aspirin are other exclusion criteria. The study population are patients who are admitted to Golestan hospital in Ahvaz and their diagnosis of intracranial hemorrhage requiring neurosurgery is confirmed by neurosurgeons.Total Sample size is 40 patients. The intervention group will receive a package containing four vials of 500 mg TXA 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 condition. Injector and staff nurses, radiologist and statistician are blind in this study.The primary outcome is determining amount of bleeding during surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031427051N1
Registration date:2016-09-04, 1395/06/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Maryam Mousavinejad
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3340 6155
Email address
mousavinejad.sm@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Ahvaz 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 intraparenchymal hemorrhage
Public title
Evaluation of Therapeutic Effect of Tranexamic Acid Infusion on Intraparenchymal Hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : age over 18 years old; attendance to the emergency room within the first 8 hours of the accident; trauma to the head with Intraparenchymal hemorrhage (IPH) on brain CT scan; absence of significant extra-cranial hemorrhage such as intra-abdominal hemorrhage; absence of fracture or deformity of limbs; absence of subarachnoid hemorrhage; absence of hematuria; absence of known coagulopathy; necessity to perform neurosurgery in clinical evaluation and according to neurosurgeon's opinion. Exclusion criteria :Existence of pregnancy; the presence of other types of intracranial hemorrhage other than intraparenchymal hematoma; need to FFP or massive whole blood transfusion; hematuria; presence of subarachnoid hemorrhage; usage of anticoagulant drugs and aspirin.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization was done by random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapour University of Medical Sciences
Street address
Ahvaz, Golestan Blvd
City
Ahvaz
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
IR.AJUMS.REC.1394.679
Health conditions studied
1
Description of health condition studied
Intracranial injury
ICD-10 code
S06.3
ICD-10 code description
Focal brain injury
Primary outcomes
1
Description
Amount of bleeding during surgery
Timepoint
during surgery
Method of measurement
Suctioned blood volume measurement
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
After surgery
Method of measurement
according to patient's documents
2
Description
Result of functional Test
Timepoint
28 days after surgery or at time of discharge
Method of measurement
Examinations conducted by researcher
3
Description
Duration of surgery
Timepoint
At time of surgery
Method of measurement
Document of patients
Intervention groups
1
Description
The intervention group will receive a package containing four vials of 500 mg TXA 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 Normalsaline added to 100 ml of 0.9% normal saline and intravenous infusion over 10 minutes) and the maintenance dose (1 g Normal saline added to 500 ml of 0.9% normal saline and intravenous infusion over 8 hours) will be administered by
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 hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice challenge for research of Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Javad Mozafari
Street address
Golestan hospital, Golestan Blvd
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice challenge for research of 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
Ph.D
Other areas of specialty/work
Street address
Golestan hospital, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 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
Ph.D
Other areas of specialty/work
Street address
Golestan hospital, Golestan Blvd
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
Seyede Maryam Mousavinejad
Position
Medical student
Other areas of specialty/work
Street address
Golestan hospital, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 21 2274 2052
Fax
Email
mousavinejad.sm@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)