Posterior Lumbar Spinal Fusion SurgeryNCT03697681
Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery
A study testing Tranexamic acid and 0.9% NaCl (normal saline) in people with Posterior Lumbar Spinal Fusion Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study was to determine whether the administration of tranexamic acid in patients undergoing lumbar spinal fusion surgery can inhibit damage in endothelial glycocalyx layer. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Posterior Lumbar Spinal Fusion Surgery
- What is being tested?
- Tranexamic acid and 0.9% NaCl (normal saline)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2018to 12 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with between 30 and 80 years scheduled for posterior lumbar spinal fusion surgery.
Who cannot join
- emergency surgery
- patients unable to make their own decisions, illiterate, foreigners
- Allergy / hypersensitivity to Tranexamic acid
- Current or past history or thrombosis / thromboembolism
- patients who are taking oral contraceptives
- Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less)
- Patients receiving anticoagulants
- pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
About this study
The aim of this study was to determine whether the administration of tranexamic acid in patients undergoing lumbar spinal fusion surgery can inhibit damage in endothelial glycocalyx layer. As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the changes in concentrations of serum syndecan-1 and heparan sulfate before and after surgery.
- Conditions
- Posterior Lumbar Spinal Fusion Surgery
- Being tested
- Tranexamic acid, 0.9% NaCl (normal saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called glutamine
Intravenous infusion of Tranexamic acid(mixed with normal saline) at the dose of 10mg/kg(body weight) for 20 min after induction of anesthesia and then administration another 1mg/kg/hr(body weight) of Tranexamic acid(mixed with normal saline) until the end of the operation.
0.9% NaCl (normal saline)Drug
The same amount of normal saline solution without the addition of tranexamic acid is administered in the same manner as the experimental group(Tranexamic acid intervention group).
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Experimental | Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia) Receives: Drug: Tranexamic acid |
| Placebo | Placebo comparator | placebo Receives: Drug: 0.9% NaCl (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
base blood concentration of syndecan-1, heparan sulfate
preoperative baseline serum levels of syndecan-1 and heparan sulfate
Measured: within 1 hour before surgery(base concentration)
blood concentration of syndecan-1, heparan sulfate at the end of the surgery
blood concentration of syndecan-1, heparan sulfate at the end of the surgery
Measured: within 5 minutes after the end of surgery (when thd surgical drape is removed)
blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery
blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery
Measured: 2 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start16 Oct 2018
- Primary completion12 Aug 2020
- Study completion12 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Lumbar Spinal Fusion SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Double-Blinded, Placebo-Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697681
- Sponsor's protocol ID
- 4-2018-0754
- Status last verified
- Oct 2020
- First submitted
- 1 Oct 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT03697681
- Acronym / sponsor ID
- 4-2018-0754
- Conditions
- Posterior Lumbar Spinal Fusion Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 12 Aug 2020 (actual)
- First posted
- 5 Oct 2018 (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 aim of this study was to determine whether the administration of tranexamic acid in patients undergoing lumbar spinal fusion surgery can inhibit damage in endothelial glycocalyx layer. As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the changes in concentrations of serum syndecan-1 and heparan sulfate before and after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Double-Blinded, Placebo-Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Experimental | Drug: Tranexamic acidIntravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia) |
| Placebo | Placebo comparator | Drug: 0.9% NaCl (normal saline)placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with between 30 and 80 years scheduled for posterior lumbar spinal fusion surgery.
Key exclusion criteria (8 listed)
- emergency surgery
- patients unable to make their own decisions, illiterate, foreigners
- Allergy / hypersensitivity to Tranexamic acid
- Current or past history or thrombosis / thromboembolism
- patients who are taking oral contraceptives
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 acidAlso: glutamineIntravenous infusion of Tranexamic acid(mixed with normal saline) at the dose of 10mg/kg(body weight) for 20 min after induction of anesthesia and then administration another 1mg/kg/hr(body weight) of Tranexamic acid(mixed with normal saline) until the end of the operation. | Drug | Glutamine |
| 0.9% NaCl (normal saline)The same amount of normal saline solution without the addition of tranexamic acid is administered in the same manner as the experimental group(Tranexamic acid intervention group). | Drug | Placebo |
Primary outcome
base blood concentration of syndecan-1, heparan sulfate
Time frame: within 1 hour before surgery(base concentration)
preoperative baseline serum levels of syndecan-1 and heparan sulfate
blood concentration of syndecan-1, heparan sulfate at the end of the surgery
Time frame: within 5 minutes after the end of surgery (when thd surgical drape is removed)
blood concentration of syndecan-1, heparan sulfate at the end of the surgery
blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery
Time frame: 2 hours after the end of surgery
blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid and 0.9% NaCl (normal saline) in people with Posterior Lumbar Spinal Fusion Surgery, run by Yonsei University at 1 site in South Korea.
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 1 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: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
base blood concentration of syndecan-1, heparan sulfate (time frame: within 1 hour before surgery(base concentration)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2020.