Clinical trial NCT06427850: Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF)
Official title: Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Degenerative Spine Diseases
Surgical Wound
Keywords: Degenerative spine diseases
Surgical wound
Tranexamic acid (TXA)
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: postoperative drainage (mL)
timeFrame: 120 hours
Secondary outcomes:
measure: calculated total blood loss (mL)
timeFrame: 120 hours
measure: intraoperative blood loss (mL)
timeFrame: Intraoperative time
measure: duration of drain maintenance (day)
timeFrame: 120 hours
measure: length of hospital stay (day)
timeFrame: 120 hours
measure: complication of tranexamic acid (TXA) and surgery(%)
timeFrame: 120 hours
Other outcomes:
Locations:
Study officials:
References:
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