]>
IRCT20230519058227N1 IRCT 2023-07-04 Karaj University of Medical Sciences Effect of Intravenous Tranexamic Acid in Reducing in Spinal Surgeries 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) 2023-08-11 anticipated 84 Complete https://irct.ir/trial/70726 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, 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, 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 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. 3 Condition 1: Far lateral lumbar disc herniation. Condition 2: Lumbar spinal stenosis. Condition 3: Spondylolisthesis. Condition 4: Scoliosis. Condition 5: Lordosis. Condition 6: Extensive fracture of the lumbar vertebrae. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: 6 months after the final data analysis To whom: Departments and researchers of neurosurgery around the world Conditions: 1. No unauthorized use of the delivered data 2. Obtaining a written undertaking not to misuse data Where to obtain: 1. Dr. Mohammad Kamangar (Neurosurgeon) Email: dr_mkamangar@yahoo.com 2. Dr. Nima Bagheri (Medical Internship) Email: nima1376nba@yahoo.com How to obtain: Sending Email and presenting documents to be a member of the Neurosurgery Department Comments:
public Nima Bagheri
Alborz Medical School, At the end of West Bu Ali Street, Nebuvat Blv
Karaj Iran (Islamic Republic of) 3149969415 +98 26 3428 7339 nima1376nba@yahoo.com Karaj University of Medical Sciences scientific Mohammad Kamangar
Alborz Medical School, At the end of West Bu Ali Street, Nebuvat Blv
Karaj Iran (Islamic Republic of) 3149969415 +98 26 3428 7339 dr_mkamangar@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) 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. no limit no limit Both 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. Treatment - Drugs Placebo 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. 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. 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. 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. Karaj University of Medical Sciences Approved 2023-06-10 Research Ethics Committees of Alborz University of Medical Sciences 45 Meters Golshahr Ave, Saffarian Alley, Deputy of Research and Technology Karaj Alborz Iran (Islamic Republic of)