Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-17 @ 10:38 PM
Study NCT ID:
NCT06427850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF)
Sponsor:
Thanawan Longsuwan
Organization:
Study Overview
Official Title:
Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF): A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: