Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF)

Surgical Wound Clinical Trial

Official title:

Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF): A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427850
• Other study ID #: 123678
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: May 2024
• Source: Ramathibodi Hospital
• Contact: Thanawan Longsuwan, Doctor of medicine
• Phone: (+66)892966855
• Email: bland.demon3[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Diseases
• Surgical Wound

Intervention

Drug:
• Tranexamic acid
receive an injection of Tranexamic acid into the surgical site
• Normal saline
receive an injection of Normal saline into the surgical site

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thanawan Longsuwan

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative drainage (mL)	Fluid drainage after operation	120 hours
Secondary	calculated total blood loss (mL)	calculated total blood loss by Gross formular	120 hours
Secondary	intraoperative blood loss (mL)	Evaluated by anesthesiologists	Intraoperative time
Secondary	duration of drain maintenance (day)	Duration time of drain insertion to off drain	120 hours
Secondary	length of hospital stay (day)	Duration time of patients stay in hospital	120 hours
Secondary	complication of tranexamic acid (TXA) and surgery(%)	The patients who had complication from tranexamic acid (TXA) and surgery in each group	120 hours