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assessment of the effect of tranexamic acid on intraoperative blood loss in patients undergoing craniotomy for tumor excision

Protocol summary

Summary
To conduct the study, 50 patients with age range of 18 to 60 years, ASA class 1 or 2, who are candidates for surgery to remove a brain tumor, will be enrolled in the study. Patients with liver, kidney and blood disorders will be excluded from the study. The amount of hemoglobin, prothrombin time with international normalized ratio, platelet count and hematocrit will be measured. General anesthesia will be induced by 2mg/kg fentanyl and 5mg/kg thiopental. Muscular relaxation will be done by 0.5mg/kg atracurium . After Intubation of patient, carbon dioxide of the end of tidal volume and blood pressurewill be monitored. Patients will be randomly assigned to one of the two groups. The TXA group will receive 15mg/kg of drug in 500 mL normal saline during 30 minutes and the saline group will receive only similar volume of normal saline. Anesthesia will be maintained by isoflurane. Ventilation parameters, will be set in order to maintain the tidal volume of carbon dioxide in 30-40 mmHg. Fluid Therapy will be managed, by prescribing colloid and crystalloid soluble. The amount of hemorrhage during surgery will be substituted by an equal volume of packed cell. An adequate substitution and also preservation of intravascular volume, will be managed by blood pressure monitoring and urine output. The amount of hemoglobin will be measured before and also 24 hours after operation. One day after operation, POD, Hb and HCT will be measured. The amount of bleeding will be compared between the two groups at the end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016122631573N1
Registration date: 2017-03-21, 1396/01/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-21, 1396/01/01
Registrant information
Name
Mehdi Kiaei
Name of organization / entity
Jondishapour University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 5272 9554
Email address
kiaei.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Expected recruitment start date
2016-07-25, 1395/05/04
Expected recruitment end date
2017-01-22, 1395/11/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
assessment of the effect of tranexamic acid on intraoperative blood loss in patients undergoing craniotomy for tumor excision
Public title
assessment of the effect of tranexamic acid on intraoperative blood loss in patients who undergo the surjery which the skull is opened in, for tumor excision
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria: Patients with liver, kidney and blood disorders or with previous thrombosis disease; poses of bleeding disorders; abnormal coagulation parameters (prothrombin time and platelet count) ; systolic blood pressure more than 185 on the day of surgery; the patients who were taking aspirin or any kind of anticoagulant a week before the surgery; patients who had history of intracranial arteries surgery and also patients who their surgery will take 3 to 6 hours, will be excluded from study. Inclusion criteria: Brain Tumor; age range of 18 to 60 years; ASA class 1 or 2.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.AJUMS.REC.1395.510

Health conditions studied

1

Description of health condition studied
brain tumor
ICD-10 code
G94.8
ICD-10 code description
Other specified disorders of brain in diseases classified elsewhere

Primary outcomes

1

Description
The amount of intraoperative bleeding
Timepoint
Every hour after the intervention
Method of measurement
Through suction container, the number of blood gases and also blood surgical field

Secondary outcomes

1

Description
Comparing EBL between the group which receives TXA and the control group, in patients undergoing craniotomy for tumor excision.
Timepoint
27 hours after the intervention
Method of measurement
Based on hemoglobin levels and by formulation

2

Description
Comparing the number of consumed packed cells , between the group which receives TXA and the control group, in patients undergoing craniotomy for tumor excision.
Timepoint
3-8 hours after the intervention
Method of measurement
counting the number of packed cells

3

Description
Comparing the amount of bleeding in mL, between the group which receives TXA and the control group, in patients undergoing craniotomy for tumor excision.
Timepoint
Every hour after the intervention
Method of measurement
Through suction container, the number of blood gases and also blood surgical field

Intervention groups

1

Description
Control group: Placebo is injected to the patients of this group. Twenty five Patients with brain tumor, age range of 18 to 60 years and ASA class 1 or 2 are in this group. Saline group will receive 15mg/kg of saline. At the end, the amount of bleeding will be measured.
Category
Treatment - Drugs

2

Description
Intervention group : Assessment of the effect of Tranexamic acid on intraoperative blood loss , is the purpose. Tranexamic acid will be injected to 25 Patients with brain tumor , age range of 18 to 60 years and ASA class 1 or 2 . The TXA group will receive 15mg/kg of drug in 500 mL normal saline during 30 minutes. At the end, the amount of bleeding will be measured.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr. Mahdi Kiaei
Street address
Golestan Hospital, Golestan Ave
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Pardis Vakili
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
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 Jundishapur University Of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Pardis Vakili
Position
Nutritionist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Phone
+98 61 3337 5717
Fax
Email
vakilipardis@yahoo.comvakili.p@ajums .ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Madi Kiaei
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Phone
+98 61 3161
Fax
Email
Dr.kiaeimehdi@yahoo.comkiaei.m@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Pardis Vakili
Position
Nutritionist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Phone
+98 61 3161
Fax
Email
vakilipardis@yahoo.comvakili.p@ajums.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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