Spinal DisordersNCT07288697
Dose-Dependent Effects of Intraoperative Tranexamic Acid on Surgical Bleeding and Transfusion Requirements in Multilevel Thoracolumbar Spinal Surgery
A study testing low-dose TXA and high-dose TXA in people with Spinal Disorders and Degenerative Spine Disease, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Multilevel spinal stabilization surgery is frequently associated with substantial blood loss and increased transfusion requirements. Tranexamic acid (TXA), an antifibrinolytic agent, reduces perioperative bleeding, but the optimal intravenous dosing regimen remains controversial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Disorders, Degenerative Spine Disease, Blood Loss, Surgical
- What is being tested?
- low-dose TXA and high-dose TXA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Apr 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18-65 years
- Scheduled for elective ≥3-level spinal stabilization surgery under general anesthesia
Who cannot join
- History of thromboembolic events
- Myocardial infarction
- Stroke
- Hepatic or renal failure,
- Known allergy to TXA
- Bleeding or coagulation disorders,
Show all 9Show fewer
- ASA physical status IV
- Trauma or tumor surgery
- Refusal to provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar Şehir Hastanesi
Istanbul, 34865
About this study
Multilevel spinal stabilization surgery is frequently associated with substantial blood loss and increased transfusion requirements. Tranexamic acid (TXA), an antifibrinolytic agent, reduces perioperative bleeding, but the optimal intravenous dosing regimen remains controversial.
This study aimed to compare the efficacy and safety of two TXA dosing protocols in patients undergoing ≥3-level spinal stabilization surgery.
Read the detailed description
Multilevel spinal stabilization surgery is frequently associated with substantial blood loss and increased transfusion requirements. Tranexamic acid (TXA), an antifibrinolytic agent, reduces perioperative bleeding, but the optimal intravenous dosing regimen remains controversial.
This study aimed to compare the efficacy and safety of two TXA dosing protocols in patients undergoing ≥3-level spinal stabilization surgery.In this prospective, randomized trial, 62 adult patients scheduled for elective thoracolumbar stabilization involving three or more levels were assigned to receive either low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion or high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion.TXA was administered intravenously 15 minutes before incision.
Intraoperative blood loss, transfusion requirements, perioperative laboratory values, and complications (thromboembolic, neurological, renal, allergic, and seizure-related) were recorded. Patients were monitored for 48 hours postoperatively.
- Being tested
- low-dose TXA, high-dose TXA
- Keywords
- Tranexamic acid, Spinal surgery, Bleeding, Blood transfusion
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose TXADrug
Also called Tranexamic acid loading, Tranexamic acid infusion
low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion
high-dose TXADrug
Also called Tranexamic asid loading, Tranexamic asid infusion
high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion
| Study group | Role | What they receive |
|---|---|---|
| low-dose tranexamic acid | Active comparator | low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion Receives: Drug: low-dose TXA |
| high-dose tranexamic acid | Active comparator | high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion Receives: Drug: high-dose TXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Blood Loss [Milliliters]
The total amount of blood lost during surgery, measured in milliliters.
Measured: During the operation
Number of Patients Requiring Intraoperative Erythrocyte Suspension Transfusion [Number of Participants]
Number of participants who required intraoperative erythrocyte suspension (ES) transfusion.
Measured: During the operation
Secondary outcomes (9)
Postoperative Hemoglobin Level at 24 and 48 Hours [g/dL]
Hemoglobin values measured at 24 and 48 hours after surgery.
Measured: 24 and 48 hours postoperatively
Postoperative Hematocrit Level at 24 and 48 Hours [Percent (%)]
Hematocrit levels measured at 24 and 48 hours after surgery.
Measured: 24 and 48 hours postoperatively
Postoperative Platelet Count at 24 and 48 Hours [×10⁹/L or per mm³]
Platelet count measured at 24 and 48 hours after surgery.
Measured: 24 and 48 hours postoperatively
Aspartate Aminotransferase (AST) Level at 24 and 48 Hours [U/L]
Biochemical Parameters
Measured: 24 and 48 hours postoperatively
Alanine Aminotransferase (ALT) Level at 24 and 48 Hours [U/L]
Biochemical Parameters
Measured: 24 and 48 hours postoperatively
Blood Urea Nitrogen (BUN) Level at 24 and 48 Hours [mg/dL]
Biochemical Parameters
Measured: 24 and 48 hours postoperatively
Creatinine Level at 24 and 48 Hours [mg/dL]
Biochemical Parameters
Measured: 24 and 48 hours postoperatively
Incidence of Postoperative Nausea and Vomiting [Number of Participants]
Number of participants experiencing nausea and vomiting within 48 hours after surgery, potentially related to tranexamic acid (TXA) administration.
Measured: First 48 hours postoperatively
Incidence of Serious Adverse Events Related to Tranexamic Acid [Number of Participants]
Number of participants experiencing serious adverse events attributable to tranexamic acid use.
Measured: First 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Nov 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Belgüzar Özsert Bilgin, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288697
- Sponsor's protocol ID
- KDrLKSH-AVR-BOB-01
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Dependent Effects of Intraoperative Tranexamic Acid on Surgical Bleeding and Transfusion Requirements in Multilevel Thoracolumbar Spinal Surgery
- ClinicalTrials.gov ID
- NCT07288697
- Acronym / sponsor ID
- KDrLKSH-AVR-BOB-01
- Keywords
- Tranexamic acid, Spinal surgery, Bleeding, Blood transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 17 Dec 2025 (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.
Multilevel spinal stabilization surgery is frequently associated with substantial blood loss and increased transfusion requirements. Tranexamic acid (TXA), an antifibrinolytic agent, reduces perioperative bleeding, but the optimal intravenous dosing regimen remains controversial.
This study aimed to compare the efficacy and safety of two TXA dosing protocols in patients undergoing ≥3-level spinal stabilization surgery.
Detailed description
Multilevel spinal stabilization surgery is frequently associated with substantial blood loss and increased transfusion requirements. Tranexamic acid (TXA), an antifibrinolytic agent, reduces perioperative bleeding, but the optimal intravenous dosing regimen remains controversial.
This study aimed to compare the efficacy and safety of two TXA dosing protocols in patients undergoing ≥3-level spinal stabilization surgery.In this prospective, randomized trial, 62 adult patients scheduled for elective thoracolumbar stabilization involving three or more levels were assigned to receive either low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion or high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion.TXA was administered intravenously 15 minutes before incision.
Intraoperative blood loss, transfusion requirements, perioperative laboratory values, and complications (thromboembolic, neurological, renal, allergic, and seizure-related) were recorded. Patients were monitored for 48 hours postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-dose tranexamic acid | Active comparator | Drug: low-dose TXAlow-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion |
| high-dose tranexamic acid | Active comparator | Drug: high-dose TXAhigh-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 18-65 years
- Scheduled for elective ≥3-level spinal stabilization surgery under general anesthesia
Key exclusion criteria (9 listed)
- History of thromboembolic events
- Myocardial infarction
- Stroke
- Hepatic or renal failure,
- Known allergy to TXA
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 |
|---|---|---|
| low-dose TXAAlso: Tranexamic acid loading, Tranexamic acid infusionlow-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion | Drug | low-dose tranexamic acid |
| high-dose TXAAlso: Tranexamic asid loading, Tranexamic asid infusionhigh-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion | Drug | high-dose tranexamic acid |
Primary outcome
Intraoperative Blood Loss [Milliliters]
Time frame: During the operation
The total amount of blood lost during surgery, measured in milliliters.
Number of Patients Requiring Intraoperative Erythrocyte Suspension Transfusion [Number of Participants]
Time frame: During the operation
Number of participants who required intraoperative erythrocyte suspension (ES) transfusion.
9 secondary outcomes
Postoperative Hemoglobin Level at 24 and 48 Hours [g/dL]
Time frame: 24 and 48 hours postoperatively
Postoperative Hematocrit Level at 24 and 48 Hours [Percent (%)]
Time frame: 24 and 48 hours postoperatively
Postoperative Platelet Count at 24 and 48 Hours [×10⁹/L or per mm³]
Time frame: 24 and 48 hours postoperatively
Aspartate Aminotransferase (AST) Level at 24 and 48 Hours [U/L]
Time frame: 24 and 48 hours postoperatively
Alanine Aminotransferase (ALT) Level at 24 and 48 Hours [U/L]
Time frame: 24 and 48 hours postoperatively
Blood Urea Nitrogen (BUN) Level at 24 and 48 Hours [mg/dL]
Time frame: 24 and 48 hours postoperatively
Creatinine Level at 24 and 48 Hours [mg/dL]
Time frame: 24 and 48 hours postoperatively
Incidence of Postoperative Nausea and Vomiting [Number of Participants]
Time frame: First 48 hours postoperatively
Incidence of Serious Adverse Events Related to Tranexamic Acid [Number of Participants]
Time frame: First 48 hours postoperatively
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 17 Dec 2025.
- 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. 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 low-dose TXA and high-dose TXA in people with Spinal Disorders and Degenerative Spine Disease, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 9 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 17 Dec 2025. 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 Turkey (Türkiye). 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. 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?
Intraoperative Blood Loss [Milliliters] (time frame: During the operation). The study lists 2 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 17 Dec 2025.