Degenerative Spine DiseasesNCT06427850
Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF)
A study testing Tranexamic acid and Normal saline in people with Degenerative Spine Diseases and Surgical Wound, run by Thanawan Longsuwan.
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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Spine Diseases, Surgical Wound
- What is being tested?
- Tranexamic acid and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30-80 years old
- Degenerative spine problems including spinal stenosis, disc degeneration, spondylolithesis that indicated for single level MI-TLIF
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Kan Kaewroj, Diploma of Orthopaedics contact
About this study
Official title: Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF): A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Degenerative Spine Diseases, Surgical Wound
- Being tested
- Tranexamic acid, Normal saline
- Keywords
- Degenerative spine diseases, Surgical wound, Tranexamic acid (TXA)
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
receive an injection of Tranexamic acid into the surgical site
Normal salineDrug
receive an injection of Normal saline into the surgical site
| Study group | Role | What they receive |
|---|---|---|
| Topical tranexamic acid (TXA) injection | Experimental | receive an injection of topical tranexamic acid (TXA) into the surgical site Receives: Drug: Tranexamic acid |
| Placebo group | Placebo comparator | receive an injection Normal saline into the surgical site Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative drainage (mL)
Fluid drainage after operation
Measured: 120 hours
Secondary outcomes (5)
calculated total blood loss (mL)
calculated total blood loss by Gross formular
Measured: 120 hours
intraoperative blood loss (mL)
Evaluated by anesthesiologists
Measured: Intraoperative time
duration of drain maintenance (day)
Duration time of drain insertion to off drain
Measured: 120 hours
length of hospital stay (day)
Duration time of patients stay in hospital
Measured: 120 hours
complication of tranexamic acid (TXA) and surgery(%)
The patients who had complication from tranexamic acid (TXA) and surgery in each group
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Degenerative Spine DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thanawan Longsuwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thanawan Longsuwan, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427850
- Sponsor's protocol ID
- 123678
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
PubMed 30560029Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):936-43. doi: 10.1097/01.brs.0000158953.57966.c0.
PubMed 15834339Harms JG, Jeszenszky D. Die posteriore, lumbale, interkorporelle Fusion in unilateraler transforaminaler Technik. Oper Orthop Traumatol. 1998 Jun;10(2):90-102. doi: 10.1007/s00064-006-0112-7. No abstract available. German.
PubMed 17332991Holly LT, Schwender JD, Rouben DP, Foley KT. Minimally invasive transforaminal lumbar interbody fusion: indications, technique, and complications. Neurosurg Focus. 2006 Mar 15;20(3):E6. doi: 10.3171/foc.2006.20.3.7.
PubMed 16599422Moskowitz A. Transforaminal lumbar interbody fusion. Orthop Clin North Am. 2002 Apr;33(2):359-66. doi: 10.1016/s0030-5898(01)00008-6.
PubMed 12389281Hong JY, Kim WS, Park J, Kim CH, Jang HD. Comparison of minimally invasive and open TLIF outcomes with more than seven years of follow-up. N Am Spine Soc J. 2022 Jun 11;11:100131. doi: 10.1016/j.xnsj.2022.100131. eCollection 2022 Sep.
PubMed 35783004Kleinert K, Theusinger OM, Nuernberg J, Werner CM. Alternative procedures for reducing allogeneic blood transfusion in elective orthopedic surgery. HSS J. 2010 Sep;6(2):190-8. doi: 10.1007/s11420-009-9151-6. Epub 2010 Jan 28.
PubMed 21886535Dodd RY. The risk of transfusion-transmitted infection. N Engl J Med. 1992 Aug 6;327(6):419-21. doi: 10.1056/NEJM199208063270610. No abstract available.
PubMed 1625717Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussieres JS, McGuinness S, Byrne K, Chan MT, Landoni G, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery. N Engl J Med. 2017 Jan 12;376(2):136-148. doi: 10.1056/NEJMoa1606424. Epub 2016 Oct 23.
PubMed 27774838Danninger T, Memtsoudis SG. Tranexamic acid and orthopedic surgery-the search for the holy grail of blood conservation. Ann Transl Med. 2015 Apr;3(6):77. doi: 10.3978/j.issn.2305-5839.2015.01.25. No abstract available.
PubMed 25992376Badeaux J, Hawley D. A systematic review of the effectiveness of intravenous tranexamic acid administration in managing perioperative blood loss in patients undergoing spine surgery. J Perianesth Nurs. 2014 Dec;29(6):459-65. doi: 10.1016/j.jopan.2014.06.003. Epub 2014 Nov 20.
PubMed 25458625Xiong Z, Liu J, Yi P, Wang H, Tan M. Comparison of Intravenous versus Topical Tranexamic Acid in Nondeformity Spine Surgery: A Meta-Analysis. Biomed Res Int. 2020 Mar 9;2020:7403034. doi: 10.1155/2020/7403034. eCollection 2020.
PubMed 32219141Winter SF, Santaguida C, Wong J, Fehlings MG. Systemic and Topical Use of Tranexamic Acid in Spinal Surgery: A Systematic Review. Global Spine J. 2016 May;6(3):284-95. doi: 10.1055/s-0035-1563609. Epub 2015 Sep 21.
PubMed 27099820Gulabi D, Yuce Y, Erkal KH, Saglam N, Camur S. The combined administration of systemic and topical tranexamic acid for total hip arthroplasty: Is it better than systemic? Acta Orthop Traumatol Turc. 2019 Jul;53(4):297-300. doi: 10.1016/j.aott.2019.03.001. Epub 2019 Apr 4.
PubMed 30954338Li J, Wang L, Bai T, Liu Y, Huang Y. Combined use of intravenous and topical tranexamic acid efficiently reduces blood loss in patients aged over 60 operated with a 2-level lumbar fusion. J Orthop Surg Res. 2020 Aug 20;15(1):339. doi: 10.1186/s13018-020-01758-8.
PubMed 32819445
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06427850
- Acronym / sponsor ID
- 123678
- Conditions
- Degenerative Spine Diseases, Surgical Wound
- Keywords
- Degenerative spine diseases, Surgical wound, Tranexamic acid (TXA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Thanawan LongsuwanUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical tranexamic acid (TXA) injection | Experimental | Drug: Tranexamic acidreceive an injection of topical tranexamic acid (TXA) into the surgical site |
| Placebo group | Placebo comparator | Drug: Normal salinereceive an injection Normal saline into the surgical site |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 30-80 years old
- Degenerative spine problems including spinal stenosis, disc degeneration, spondylolithesis that indicated for single level MI-TLIF
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidreceive an injection of Tranexamic acid into the surgical site | Drug | Topical tranexamic acid (TXA) injection |
| Normal salinereceive an injection of Normal saline into the surgical site | Drug | Placebo group |
Primary outcome
postoperative drainage (mL)
Time frame: 120 hours
Fluid drainage after operation
5 secondary outcomes
calculated total blood loss (mL)
Time frame: 120 hours
intraoperative blood loss (mL)
Time frame: Intraoperative time
duration of drain maintenance (day)
Time frame: 120 hours
length of hospital stay (day)
Time frame: 120 hours
complication of tranexamic acid (TXA) and surgery(%)
Time frame: 120 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Background: PubMed 30560029Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
- Background: PubMed 15834339Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):936-43. doi: 10.1097/01.brs.0000158953.57966.c0.
- Background: PubMed 17332991Harms JG, Jeszenszky D. Die posteriore, lumbale, interkorporelle Fusion in unilateraler transforaminaler Technik. Oper Orthop Traumatol. 1998 Jun;10(2):90-102. doi: 10.1007/s00064-006-0112-7. No abstract available. German.
- Background: PubMed 16599422Holly LT, Schwender JD, Rouben DP, Foley KT. Minimally invasive transforaminal lumbar interbody fusion: indications, technique, and complications. Neurosurg Focus. 2006 Mar 15;20(3):E6. doi: 10.3171/foc.2006.20.3.7.
- Background: PubMed 12389281Moskowitz A. Transforaminal lumbar interbody fusion. Orthop Clin North Am. 2002 Apr;33(2):359-66. doi: 10.1016/s0030-5898(01)00008-6.
- Background: PubMed 35783004Hong JY, Kim WS, Park J, Kim CH, Jang HD. Comparison of minimally invasive and open TLIF outcomes with more than seven years of follow-up. N Am Spine Soc J. 2022 Jun 11;11:100131. doi: 10.1016/j.xnsj.2022.100131. eCollection 2022 Sep.
- Background: PubMed 21886535Kleinert K, Theusinger OM, Nuernberg J, Werner CM. Alternative procedures for reducing allogeneic blood transfusion in elective orthopedic surgery. HSS J. 2010 Sep;6(2):190-8. doi: 10.1007/s11420-009-9151-6. Epub 2010 Jan 28.
- Background: PubMed 1625717Dodd RY. The risk of transfusion-transmitted infection. N Engl J Med. 1992 Aug 6;327(6):419-21. doi: 10.1056/NEJM199208063270610. No abstract available.
- Background: PubMed 27774838Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussieres JS, McGuinness S, Byrne K, Chan MT, Landoni G, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery. N Engl J Med. 2017 Jan 12;376(2):136-148. doi: 10.1056/NEJMoa1606424. Epub 2016 Oct 23.
- Background: PubMed 25992376Danninger T, Memtsoudis SG. Tranexamic acid and orthopedic surgery-the search for the holy grail of blood conservation. Ann Transl Med. 2015 Apr;3(6):77. doi: 10.3978/j.issn.2305-5839.2015.01.25. No abstract available.
- Background: PubMed 25458625Badeaux J, Hawley D. A systematic review of the effectiveness of intravenous tranexamic acid administration in managing perioperative blood loss in patients undergoing spine surgery. J Perianesth Nurs. 2014 Dec;29(6):459-65. doi: 10.1016/j.jopan.2014.06.003. Epub 2014 Nov 20.
- Background: PubMed 32219141Xiong Z, Liu J, Yi P, Wang H, Tan M. Comparison of Intravenous versus Topical Tranexamic Acid in Nondeformity Spine Surgery: A Meta-Analysis. Biomed Res Int. 2020 Mar 9;2020:7403034. doi: 10.1155/2020/7403034. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kan Kaewroj, Diploma of Orthopaedics contact
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid and Normal saline in people with Degenerative Spine Diseases and Surgical Wound, run by Thanawan Longsuwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thanawan Longsuwan, Doctor of medicine ((+66)892966855, bland.demon3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative drainage (mL) (time frame: 120 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06427850, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.