Evaluation of the Effect of Intravenous Tranexamic Acid in Reducing the Amount of Intraoperative Bleeding in Major Lumbar Spinal Surgeries with Instruments (A Randomized Double-blind Clinical Trial Study)
1. Reducing the need for blood transfusion
2. Stable hemodynamic status
3. Reducing the duration of anesthesia
4. Reducing the duration of the operation
5. Reducing the duration of hospitalization
6. Reducing the risk of infection
Design
A clinical trial with a control group and an intervention group, double-blind, randomized, phase 3 on 84 patients. A table of random numbers is used for randomization.
Settings and conduct
The study is carried out in Shahid Madani Hospital of Alborz province. In the intervention group, 30 minutes before the skin incision, 10 _ 15 mg/kg of intravenous Tranexamic acid as a loading dose and during the operation 1 _ 2 mg/kg/hr as maintenance dose is injected until the end of the procedure. in the control group, placebo (Normal Saline 0.9%) is injected 30 minutes before the operation as a loading dose and during the operation as a maintenance dose with a equal volume to Tranexamic acid injected in the intervention group.
The surgeon and the patient are blinded. Tranexamic acid and placebo are injected to the patients with syringe No. 1 (for intervention) and syringe No. 2 (for control) respectively, by the anesthesiologistbased on the mentioned dose.
Participants/Inclusion and exclusion criteria
Entry conditions: Degenerative spine patients needing instrumentation
Conditions of non-entry: lack of patient consent, use of anticoagulant drugs, congenital coagulopathy disease, history of any type of cerebral hemorrhage, history of anaphylactic reaction, pregnant women, history of DVT and PTE.
Intervention groups
The intervention group (42 patients) is injected with Tranexamic acid and the control group (42 patients) is injected with placebo.
Main outcome variables
1. Bleeding volume during operation
2. The volume of blood collected daily in the Hemovac drain after the operation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230519058227N1
Registration date:2023-07-04, 1402/04/13
Registration timing:prospective
Last update:2023-07-04, 1402/04/13
Update count:0
Registration date
2023-07-04, 1402/04/13
Registrant information
Name
Nima Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4601 6447
Email address
nima1376nba@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-11, 1402/05/20
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Intravenous Tranexamic Acid in Reducing the Amount of Intraoperative Bleeding in Major Lumbar Spinal Surgeries with Instruments (A Randomized Double-blind Clinical Trial Study)
Public title
Effect of Intravenous Tranexamic Acid in Reducing in Spinal Surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient with far lateral lumbar disc herniation who requires instrumentation.
A patient with lumbar spinal stenosis who requires instrumentation.
A patient with Spondylolisthesis who requires instrumentation.
A patient with Scoliosis who requires instrumentation.
A patient with Lordosis who requires instrumentation.
A patient has a extensive fracture of the lumbar vertebrae who requires instrumentation.
Exclusion criteria:
Patient dissatisfaction
Patients taking Anticoagulant Drugs.
People with Congenital Coagulopathy.
Patients who have a history of any type of Cerebral Hemorrhage such as SAH, ICH, SDH, EDH, IVH.
Patients who have a history of Anaphylactic Reaction.
Women who are pregnant.
Patients who have a history of DVT and PTE.
Patients who have a history of Chronic Renal Failure (Cr-baseline > 1.36 mg/dl).
Patients with Chronic Liver Disease.
Patients who have Platelets < 100,000 mm3.
Patients who have INR > 1.5.
Patients who have PT > 14.
Patients who have PTT > 35.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, based on the limited randomization method, the degenerative spine patients in need of instrumentation were divided into an intervention group (group A) and control group (group B) by the method of random blocks with variable sizes obtained by the table of random numbers (with zero, even and odd numbers). There are equal numbers of intervention groups and control groups in each block.
Sequentially numbered, sealed opaque envelopes are also used for allocation concealment. In this way, a number of letter envelopes are prepared with an aluminum wrapper (in order to obscure the content of the envelopes) and each of the random sequences created is recorded on a card and the cards are placed in the letter envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double-blind study (surgeon _ patient). For this purpose, an ampoule of Tranexamic acid called syringe No. 1 (for injection in group A) and a placebo called syringe No. 2 (for injection in group B) are prepared. The anesthesiologist give injections to the patients 30 minutes before the operation and during the operation (based on the dose mentioned in the methods) according to the specified random block method. The surgeon knows which patients have participated in the study, The surgeon knows which patients have participated in the study, but no one except the anesthesiologist knows the type of injectable ampoule. Also, all patients know that they have participated in this study, but they do not know about the type of injectable ampoule.
Placebo
Used
Assignment
Other
Other design features
In this study, based on the sample size calculations, 84 patients are selected and with the random allocation method, the patients will be divided into the intervention group (group A) and the control group (group B) based on the random block design. The intervention group will be injected intravenous Tranexamic acid, and the control group will receive a placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Alborz University of Medical Sciences
Street address
45 Meters Golshahr Ave, Saffarian Alley, Deputy of Research and Technology
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.ABZUMS.REC.1402.078
Health conditions studied
1
Description of health condition studied
Far lateral lumbar disc herniation
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Lumbar spinal stenosis
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Spondylolisthesis
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Scoliosis
ICD-10 code
ICD-10 code description
5
Description of health condition studied
Lordosis
ICD-10 code
ICD-10 code description
6
Description of health condition studied
Extensive fracture of the lumbar vertebrae
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding volume during operation
Timepoint
During operation
Method of measurement
By collecting the amount of blood in the suction and subtracting its amount from the amount of serum that was used in the washing place (the amount of serum used is noted) and counting the number of blood cells approximately.
2
Description
The volume of blood collected daily in the hemovac drain after the operation
Timepoint
After installing the Hamovac drain on a daily basis
Method of measurement
The amount of blood collected in the Hemovac drain is charted daily in coordination with the surgeon.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group (group A), 30 minutes immediately before the skin incision,10 _ 15 mg/kg of intravenous Tranexamic acid as a loading dose (do not exceed the injection of 100 mg/min) and during the operation 1 _ 2 mg/kg/hr as maintenance dose is injected until the end of the procedure.
Category
Treatment - Drugs
2
Description
In the control group (group B), placebo (normal saline 0.9%) is injected 30 minutes before the operation as a loading dose and during the operation as a maintenance dose with a equal volume to Tranexamic acid injected in the intervention group.