Degenerative Spine Diseases, Surgical Wound
Conditions
Keywords
Degenerative spine diseases, Surgical wound, Tranexamic acid (TXA)
Brief summary
The randomized controlled study which compare the efficacy outcomes (reducing blood loss and drainage output in patients) in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) and received topical tranexamic acid injection in the surgical site to those who received placebo injection.
Detailed description
Detail : Randomization of Patients for intra-surgical site topical tranexamic acid injection Objective : To compare the efficacy of topical tranexamic acid (TXA) injection into the surgical wound versus placebo injection in reducing blood loss and drainage output in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) surgery. Methods: Patient: Patients with degenerative spine conditions undergoing single-level MI-TLIF surgery, who received treatment at Ramathibodi Hospital and Chakri Naruebodindra Medical Institute from 2024 to 2027. Randomization : Patients will be randomly by various block randomization (1:1) was performed using STATA 16.0 to ensure that the two groups were comparable in size and that the sequence of randomization was unpredictable. Intervention : Group 1 : Patients in this group will receive an injection of topical tranexamic acid (TXA) into the surgical site(50mg/ml) 10 ml after wound exposure and after wound decompression. Group 2: Patients in this group will receive a placebo injection (Normal saline 10 ml) into the surgical site after wound exposure and after wound decompression. Allocation Concealment : A central randomization service will prepare sealed envelopes labeled with sequence numbers corresponding to the sample size. This method decreasing selection bias in assigning participants to the treatment groups. The envelopes were opened and equipment prepared after anesthesia was administered and before the surgeon began the incision. Blinding : The study participants and assessors will be blinded to treatment allocation. The surgeons were blinded by clear fluid as same in 2 groups but if tranexamic acid can be effective to decrease blood loss in intraoperation. So we cannot controlled blinding surgeons. Primary outcome measurement: postoperative drainage (ml) Secondary outcome measurement: calculated total blood loss, intraoperative blood loss, blood transfusion rate, duration of drain maintenance, length of hospital stay, complication of tranexamic acid (TXA) and surgery. Statistical Analysis: Demographic Analysis : For continuous data reported as Mean and Standard Deviation (S.D.) and analyzed by Independent t-test or Mann-Whitney U test. For categorical data reported as Percentages and analyzed by Chi-square test. Compare the results of the study: Postoperative drainage (ml),calculated total blood loss (ml), intraoperative blood loss (mL) , duration of drain maintenance (day), length of hospital stay (day)were report to Mean and Standard Deviation (S.D.) analyzed by Independent t-test or Mann-Whitney U test for continuous data. Complication of tranexamic acid (TXA) and surgery(%), blood transfusion rate (%) were reported to Percentages and analyzed by Chi-square test. Use STATA 16.0 software for statistical calculations.
Interventions
DRUGTranexamic acid
receive an injection of Tranexamic acid into the surgical site
DRUGNormal saline
receive an injection of Normal saline into the surgical site
Sponsors
Thanawan Longsuwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 30-80 years old * Degenerative spine problems including spinal stenosis, disc degeneration, spondylolithesis that indicated for single level MI-TLIF
Exclusion criteria
* Revision surgery * Patients who had high risk of complication from TXA * History of seizure, PE, DVT, thromboembolic episode * History of TXA allergy * Patients who had high risk for bleeding * U/D : CKD stage more than IIIb (GFR\< 45 ml/min/1.73m2), hepatic disease, bleeding disorder * On anticoagulation drug or antiplatelet drug in 7 days before surgery * Abnormal coagulation profile (INR \> 1.5) or CBC (platelet \< 100000)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative drainage (mL) | 120 hours | Fluid drainage after operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| calculated total blood loss (mL) | 120 hours | calculated total blood loss by Gross formular |
| intraoperative blood loss (mL) | Intraoperative time | Evaluated by anesthesiologists |
| duration of drain maintenance (day) | 120 hours | Duration time of drain insertion to off drain |
| length of hospital stay (day) | 120 hours | Duration time of patients stay in hospital |
| complication of tranexamic acid (TXA) and surgery(%) | 120 hours | The patients who had complication from tranexamic acid (TXA) and surgery in each group |
Contacts
Primary ContactThanawan Longsuwan, Doctor of medicine
Backup ContactKan Kaewroj, Diploma of Orthopaedics
Outcome results
None listed