Tranexamic Acid for Spine Surgery Patients

Overseen By Matthew Colman, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Rush University Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Breastfeeding, Thromboembolic disease, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3 days

604 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether different methods of administering tranexamic acid (a medication used to reduce bleeding) can reduce blood loss after spine surgery. It compares oral administration to intravenous (IV) administration, aiming to determine if oral doses are as effective, or possibly more effective, than a single IV dose. Candidates for a specific type of spine surgery may be suitable participants, particularly if they have not recently taken blood thinners or experienced previous blood clots. As an Early Phase 1 trial, this research seeks to understand how the treatment works in people, providing participants an opportunity to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

If you are taking anticoagulant therapy, you must stop it at least five days before surgery to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tranexamic acid (TXA) is generally safe for use in spine surgeries. Studies have found that both intravenous (IV) and oral TXA can reduce the need for blood transfusions during these operations, meaning patients lose less blood and are less likely to require additional blood.

For IV TXA, research indicates that even at higher doses, it does not lead to more complications, suggesting it is safe and effective for reducing blood loss. One study found that low-dose IV TXA helps reduce blood loss and maintain hemoglobin levels, which are crucial for preventing anemia, a condition characterized by insufficient healthy red blood cells.

Oral TXA appears even safer, with fewer complications, especially for patients not at high risk, making it a good option for many undergoing spine surgery.

Overall, both IV and oral TXA are well-tolerated and have a low risk of side effects, making them reliable options for managing blood loss in spine surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about tranexamic acid (TXA) for spine surgery patients because it tackles bleeding in a novel way. Most treatments for reducing surgical bleeding involve clotting agents or blood transfusions. However, TXA is unique because it helps stabilize and strengthen blood clots by blocking the breakdown process, known as fibrinolysis. This trial is testing three different ways to administer TXA: intravenously, as a pre-surgery oral dose, and as a full oral regimen. By exploring these new delivery methods, researchers hope to find the optimal approach for minimizing blood loss with fewer side effects and complications compared to traditional treatments.

What evidence suggests that this trial's treatments could be effective for reducing postoperative blood loss in spine surgery patients?

Research has shown that tranexamic acid (TXA) reduces blood loss during spine surgeries. In this trial, participants will receive either IV TXA, pre-operative oral TXA, or full oral TXA. Studies have found that both IV (administered through a vein) and oral (taken by mouth) TXA significantly lower blood loss and reduce the need for transfusions. TXA prevents the breakdown of blood clots, controlling bleeding during and after surgery. Some studies suggest that the method of administration—whether through a vein or by mouth—does not significantly affect effectiveness. Overall, TXA is widely used and proven to manage blood loss in spinal surgeries. ^{2 3 6 7 8}

Who Is on the Research Team?

Bryce Basques, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 scheduled for open posterior thoracolumbar spinal fusion surgery. It's not suitable for those allergic to TXA, refusing blood products, with recent heart attacks, severe lung or liver disease, color vision issues, recent anticoagulant use, kidney impairment, pregnant or breastfeeding women, and those with a history of clotting disorders.

Inclusion Criteria

I am scheduled for a specific back surgery involving the spine.

I am older than 18 years old.

Exclusion Criteria

You are currently breastfeeding.

You are pregnant.

I have kidney problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either placebo, IV TXA, pre-operative oral TXA, or full oral TXA regimen during and after spine surgery

3 days

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of transfusion rates and postoperative blood loss

3-4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid
• Vitamin C 250 MG Oral Tablet

Trial Overview The study tests if multiple doses of oral Tranexamic Acid (TXA) can reduce post-surgery blood loss and transfusion needs compared to a single dose regimen. It also compares the effectiveness of oral TXA against intravenous delivery in patients undergoing spine surgery.

How Is the Trial Designed?

Group I: Group 4 Full Oral TXA Experimental Treatment 1 Intervention

Group II: Group 3 Pre-Oral TXA Experimental Treatment 2 Interventions

Group III: Group 2 IV TXA Experimental Treatment 2 Interventions

Group IV: Group 1 PLACEBO Placebo Group 1 Intervention

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

Paclitaxel demonstrates significant antiplatelet activity by inhibiting collagen-induced platelet aggregation, with an IC(50) of 59.7, suggesting it may effectively block collagen-mediated signaling pathways.

The drug also interferes with thromboxane A2 (TXA2) synthesis and cytosolic calcium mobilization, indicating a potential mechanism for its cardiovascular benefits beyond its anticancer effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The protective effects of paclitaxel on platelet aggregation through the inhibition of thromboxane A2 synthase. Lee, JJ., Yu, JY., Lee, JH., et al.[2015]

A 20-year-old man experienced anaphylactic shock during spinal surgery due to tranexamic acid (TXA), highlighting a serious safety concern with this increasingly used medication.

This case adds to the growing literature, now totaling five reported instances of anaphylaxis related to TXA in patients with no prior exposure, indicating that even commonly used drugs can pose unexpected risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylactic Reaction to Tranexamic Acid During Posterior Spinal Fusion: A Case Report. Plaster, S., Holy, F., Antony, AK.[2023]

The study demonstrated that the TXA2 receptor antagonist BAY U 3405 effectively blocks TXA2-mediated processes, which are linked to sudden death in a model of AA-induced mortality, indicating its potential as a therapeutic agent.

BAY U 3405 shows a rapid onset and long duration of action, with effective doses ranging from 1 to 3 mg/kg, suggesting it could be beneficial for treating diseases associated with TXA2 dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of BAY U 3405, a new thromboxane antagonist, on arachidonic acid induced thromboembolism. Seuter, F., Perzborn, E., Fiedler, VB.[2013]

Intravenous tranexamic acid (TXA) significantly reduces intraoperative blood loss and total blood loss in patients undergoing complex multilevel spinal surgery, based on a meta-analysis of 7 studies involving 441 patients.

While different dosing regimens of TXA were analyzed, no significant differences in intraoperative blood loss were found among the regimens, although the combination of 15 mg/kg + 1 mg/kg/h showed the most substantial reduction in total blood loss compared to placebo and other doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid dosing strategies and blood loss reduction in multilevel spine surgery: A systematic review and network meta-analysis: Tranexamic acid for multilevel spine surgery. Rahmani, R., Singleton, A., Fulton, Z., et al.[2022]

Tranexamic acid (TXA) significantly reduces hidden blood loss, total blood loss, and maximum hemoglobin drop in patients undergoing pedicle screw fixation for thoracolumbar burst fractures, especially with a two-dose regimen.

The use of TXA does not adversely affect liver and renal function, coagulation, or increase the risk of complications, while also lowering post-operative inflammatory markers like interleukin-6 and C-reactive protein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of multiple-dose intravenous tranexamic acid in reducing perioperative blood loss in patients with thoracolumbar burst fracture. Wang, F., Nan, L., Feng, X., et al.[2021]

In a study of 223 patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis, high-dose tranexamic acid (TXA) significantly reduced normalized blood loss by 36% and total estimated blood loss by 37.5% compared to low-dose TXA.

Patients receiving high-dose TXA also experienced a 48% reduction in the need for red blood cell transfusions, with only 19% requiring a transfusion compared to 67% in the low-dose group, highlighting the efficacy of high-dose TXA in managing blood loss during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High- versus low-dose tranexamic acid as part of a Patient Blood Management strategy for reducing blood loss in patients undergoing surgery for adolescent idiopathic scoliosis. Tumber, S., Bacon, A., Stondell, C., et al.[2023]

In a case of accidental intrathecal injection of tranexamic acid (TXA) during hip surgery, the patient experienced severe neurological and cardiac complications, highlighting the potential dangers of this medication when misadministered.

The treatment involving ventriculolumbar perfusion with saline and inhalational sedation with sevoflurane showed promise in managing TXA-induced neurotoxicity, suggesting a potential approach for similar cases, although complete recovery was not achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventriculolumbar perfusion and inhalational anesthesia with sevoflurane in an accidental intrathecal injection of tranexamic acid: unreported treatment options. Godec, S., Gradisek, MJ., Mirkovic, T., et al.[2022]

Tranexamic acid (TXA) significantly reduces postoperative blood loss and the need for blood transfusions in lumbar surgery, based on a meta-analysis of 49 studies involving 4,822 patients.

TXA improves hemoglobin and hematocrit levels post-surgery without increasing the risk of deep venous thrombosis (DVT), although it does lower D-dimer levels, indicating its effectiveness in promoting hemostasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tranexamic acid in lumbar surgery: A meta-analysis of randomized-controlled trials. Xiao, K., Zhuo, X., Peng, X., et al.[2022]

A study of 36 adult patients undergoing complex spine surgeries showed that high-dose tranexamic acid (TXA) significantly reduced intraoperative blood loss, with an average of 587.1 mL, indicating its efficacy as an antifibrinolytic agent.

No thromboembolic or significant complications were reported, suggesting that high-dose TXA may be safe for use in this surgical context, although further research is needed to confirm its safety and optimal dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of High-Dose Tranexamic Acid in Spine Surgery: A Retrospective Single-Institution Series. Brown, NJ., Pennington, Z., Himstead, AS., et al.[2023]

In a study of 112 adult patients undergoing multilevel posterior spinal fusion surgery, the use of tranexamic acid (TXA) significantly reduced intra- and postoperative blood loss and the need for blood transfusions.

The combined systemic and local application of TXA was found to be a safe and effective strategy for conserving blood during major spinal surgeries, indicating its potential as a standard practice in such procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficiency of Simultaneous Systemic and Topical Use of Tranexamic Acid in Spinal Fusion Surgery. Erdogan, U., Sari, S., Akbas, A.[2022]

In a study of 38 patients undergoing short segment pedicle screw fixation for thoracolumbar fractures, the use of tranexamic acid (TXA) significantly reduced intraoperative bleeding compared to a control group.

Patients receiving TXA also experienced less postoperative drainage and did not require any blood transfusions, highlighting its efficacy in minimizing blood loss during spinal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Tranexamic Acid Reduce Perioperative Bleeding in Short Segment Pedicle Screw Fixation in Thoracolumbar Spine Fractures? Pradhan, RL., Pandey, BK.[2017]

TXA(2) generation in platelets can occur through different signaling pathways, specifically through αIIbβ3 integrin for ADP and independently via G(12/13) pathways for protease-activated receptors (PARs).

The study identified that while FAK activation is involved in TXA(2) generation, it occurs differently depending on the signaling pathway, indicating a complex interaction between integrin and G(12/13) signaling in platelet function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

G(12/13) signaling pathways substitute for integrin αIIbβ3-signaling for thromboxane generation in platelets. Bhavaraju, K., Lakhani, PR., Dorsam, RT., et al.[2021]

The stable analog of thromboxane A(2), carbocyclic TXA(2) (CTXA(2)), can effectively induce the formation of osteoclast-like cells in murine bone marrow cultures through a RANKL-dependent pathway, highlighting its potential role in bone metabolism.

In contrast, the unstable TXA(2) released from platelets does not contribute to osteoclast formation, as evidenced by the lack of effect from TXA(2) receptor antagonists and the failure of common anti-inflammatory drugs to inhibit osteoclastogenesis induced by platelet-released supernatants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The stable analog carbocyclic TXA2 but not platelet-released TXA2 induces osteoclast-like cell formation. Gruber, R., Schöfnagl, M., Karreth, F., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12021860/

Effect of tranexamic acid in spine surgeries: a systematic ... Low-dose IV TXA with temperature intervention and the combined use of TXA significantly improved blood loss, hemoglobin drop, and blood transfusion rate during ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1878875023005430

Safety and Efficacy of High-Dose Tranexamic Acid in Spine ... Currently, tranexamic acid (TXA) is the most widely used antifibrinolytic agent in spine surgery and has been proven to reduce perioperative blood loss.

3. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-024-08191-6

The efficacy and safety of topical combined with intravenous ... Based on the available evidences, our meta-analysis failed to demonstrate the apparent advantages of combined tranexamic acid in spinal surgery.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03425799

Efficacy and Safety of Tranexamic Acid in Spinal Fusion ... This will be a multicenter, randomized, double-blind, parallel group study comparing tranexamic acid (test) to placebo (control) for reduction of ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40745411/

Comparative efficacy and safety of different tranexamic ... This network meta-analysis aims to compare the effectiveness and safety of various TXA administration methods in spine surgery, focusing on ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11165496/

Safety and Efficacy of Tranexamic Acid in Spinal Surgery TXA use was associated with a decreased need for blood transfusions in patients undergoing spine surgery (RR [random-effects model]=0.68, 95% CI: [0.51, 0.90], ...

7. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2025.1550854/full

Effect of tranexamic acid in spine surgeries: a systematic ... In our study, low-dose IV TXA showed significant effects on five outcomes (intraoperative blood loss, postoperative blood loss, hemoglobin drop, ...

8. wjgnet.com wjgnet.com/2218-5836/full/v15/i4/346.htm

Safety of tranexamic acid in surgically treated isolated ... TXA use for elective spine surgery is well documented but there is scarce literature to explain the safety of TXA in isolated whole spine trauma ...