Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-20
Brief Title:
Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion MI-TLIF
Sponsor:
Thanawan Longsuwan
Organization:
Ramathibodi Hospital
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 11 was performed using STATA 160 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 site50mgml 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 SD 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 mlcalculated total blood loss ml intraoperative blood loss mL duration of drain maintenance day length of hospital stay daywere report to Mean and Standard Deviation SD 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 160 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 11 was performed using STATA 160 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 site50mgml 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 SD 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 mlcalculated total blood loss ml intraoperative blood loss mL duration of drain maintenance day length of hospital stay daywere report to Mean and Standard Deviation SD 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 160 software for statistical calculations
Study Oversight
Has Oversight DMC:
None
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?:
None