Evaluation of coagulation effects of tranexamic acid on bleeding rate in patients undergoing surgery for cerebral supratentorial tumors
Design
A clinical trial with parallel groups, double-blind, randomized, phase 2 on 60 patients, the lottery method will be used for randomization.
Settings and conduct
The present study will be conducted as a double-blind clinical trial (patients and outcome evaluator) randomized in Imam Hossein and Shahada hospitals in Tajrish.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 16 years; The need for surgery for supratentorial brain tumors.
Exclusion criteria: the existence or a history of diseases such as digestive disorders, heart diseases, kidney failure, coagulation disorders, medication sensitivity, thromboembolism.
Intervention groups
In group A, after induction of general anesthesia and before skin incision, a dose of 20 mg / kg of transamic acid is injected and to induce anesthesia, midazolam (02.0-05.0 mg / kg), fentanyl (4-5 micrograms / kg) are injected. Cis atracurium (0.2 mg / kg), lidocaine (1 mg / kg) and propofol anesthetic (2 mg / kg) will be used. The maintenance dose injection will continue until the skin is completely closed. In group B, after induction of general anesthesia and before cutting the skin, a single dose of 20 mg / kg of tranxamic acid is injected and after the initial loading dose, the amount of 3 mg / kg / hour of tranxamic acid will be injected until Complete skin closure will continue.
Main outcome variables
Hematocrit; Bleeding volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190202042588N3
Registration date:2022-10-24, 1401/08/02
Registration timing:registered_while_recruiting
Last update:2022-10-24, 1401/08/02
Update count:0
Registration date
2022-10-24, 1401/08/02
Registrant information
Name
Sara Salarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 1601
Email address
sarasalarian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of coagulation effects of tranexamic acid on bleeding rate in patients undergoing surgery for cerebral supratentorial tumors
Public title
Evaluation of coagulation effects of tranexamic acid in patients undergoing surgery for cerebral supratentorial tumors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All surgeries for supratentorial tumors
Age over 16 years
Discontinue drugs that cause coagulation disorders
Women in non-pregnant status
Exclusion criteria:
history of coagulation disorders
history of gastrointestinal disease
history of liver disease
history of heart disease
history of renal failure (creatinine clearance less than 70min / mL, oliguria or dialysis 28 days before surgery)
history of diabetes
history of hypersensitivity disorders to ibuprofen, aspirin, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors
history of asthma
long-term use of anticonvulsant drugs
smoking
Age
From 16 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, random allocation (lottery method) will be used. For this purpose, the letter A (drug identifier) will be written on 30 sheets of paper, and all letters B will be written on the other 30 papers. It is closed and placed inside the box, then the papers will be randomly removed from the box for each patient without replacement, and the created sequence will be recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
The different doses of the drug will be completely similar, and the nurse will not know about the drug dose, and the patient will not know about the drug dose or whether it is a placebo, and after testing, the patients' information will be delivered to the analyzer in two groups with numbers one and two.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Intervention group: In group A, after induction of general anesthesia and before incision of the skin, a dose of 20 mg / kg of transamic acid is injected after the initial loading dose. The dose of 1 mg / kg / h will also be injected as a maintenance dose throughout the surgery and in a continuous infusion. The maintenance dose will be injected until the skin is completely closed.
Category
Treatment - Drugs
2
Description
Intervention group: In group B, after induction of general anesthesia and before cutting the skin, a single dose of 20 mg / kg of tranxamic acid is injected and after the initial loading dose, 3 mg / kg / h of tranxamic acid will be injected until Complete skin closure perseveranceWill find.