Tranexamic Acid for Spinal Injury

Recruiting at 5 trial locations

Overseen By Matthew J. Cooney

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Columbia University

Must not be taking: Anticoagulants, NSAIDs, Factor IX

Disqualifiers: Age <18 or >80, Sepsis, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

252 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if applying tranexamic acid directly to a surgical wound can reduce blood loss and the need for blood transfusions during and after spinal surgery. It involves patients requiring surgery for spinal injuries, particularly those undergoing complex procedures. Participants will be divided into two groups: one will receive tranexamic acid, while the other will receive a placebo (a harmless saline solution). Ideal candidates are adults with a thoracic or lumbar spine injury requiring surgery within 21 days. As a Phase 2 and Phase 3 trial, this research evaluates the treatment's effectiveness in a larger group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking medical advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulant medications (like heparin or warfarin) three days before surgery and non-steroidal anti-inflammatory drugs (like aspirin or ibuprofen) seven days before surgery. If you are on these medications, you will need to stop them before participating.

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

Research has shown that tranexamic acid is generally safe for use in spinal surgeries. Studies have found that it reduces blood loss during surgery without increasing the risk of complications. One study used high doses of tranexamic acid safely, resulting in fewer blood transfusions for patients. Another review found that low doses also led to less blood loss during and after surgery. Tranexamic acid is well-documented for use in planned spine surgeries, although less information exists on its safety in spine injuries. Overall, evidence suggests that tranexamic acid is well-tolerated in these situations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for spinal injuries, which often focus on rehabilitation and pain management, tranexamic acid offers a novel approach by potentially minimizing bleeding during surgery. This medication works by inhibiting enzymes that break down blood clots, thereby reducing blood loss and improving surgical outcomes. Researchers are excited because this could lead to faster recovery times and fewer complications, making spinal surgeries safer and more efficient.

What evidence suggests that tranexamic acid might be an effective treatment for reducing perioperative blood loss in spinal injury surgery?

Studies have shown that tranexamic acid reduces blood loss during spinal surgeries. It lowers the need for blood transfusions and decreases bleeding both during and after surgery. Research indicates that tranexamic acid is effective in various types of spine surgeries, including complex ones. This trial will compare tranexamic acid, which participants may receive, with a placebo control. Tranexamic acid is widely used and generally safe for patients. Overall, it is expected to help reduce bleeding during and after surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Ronald A Lehman, M.D.

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

Adults with thoracic or lumbar spine injuries from trauma or needing complex surgery, who can have surgery within 21 days of injury and require long spinal fusions. Excluded are those with low hemoglobin, recent anticoagulant use, severe brain injuries, other trial participation, certain blood disorders, pregnancy/breastfeeding, history of thrombosis or seizures, major organ damage or serious comorbidities.

Inclusion Criteria

My surgery is scheduled within 3 weeks of my injury.

I need surgery for a spine injury in my chest or lower back area.

I am having a spinal fusion surgery involving more than 5 levels.

Exclusion Criteria

I have significant kidney or liver problems.

Ballistic spinal column injury

Allergy to tranexamic acid

Timeline for a Trial Participant

Screening/Enrollment

Participants are screened for eligibility to participate in the trial

Up to 3 weeks

1 visit (in-person)

Inpatient Data Collection

Participants undergo surgery and data is collected for 4 days postoperatively

4 days

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Visits at 2 weeks, 16 weeks, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tranexamic Acid

Trial Overview

The study tests if tranexamic acid reduces blood loss during and after spine trauma surgery compared to a placebo. It's randomized and double-blind meaning neither the patients nor the doctors know who gets the real treatment versus saline solution. The follow-up is for two years with several check-ins.

How Is the Trial Designed?

Group I: Intervention Active Control 1 Intervention

Subjects will receive tranexamic acid on the surgical wound.

Group II: Placebo control Placebo Group 1 Intervention

Subjects will receive placebo (saline solution) on the surgical wound.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

In a study involving 30 patients with early cervical myelopathy, Riluzole did not show significant improvements in clinical outcomes or diffusion tensor imaging (DTI) metrics after one month of treatment compared to a placebo group.

Despite the lack of significant changes in clinical scores and DTI indices, the study suggests that further research is necessary to explore the potential role of Riluzole in treating cervical myelopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Riluzole as a pharmacotherapeutic treatment option for early cervical myelopathy: a double-blinded, placebo-controlled randomised controlled trial. Rajasekaran, S., Aiyer, SN., Shetty, AP., et al.[2018]

In a mouse model of spinal cord injury (SCI), tranexamic acid (TXA) significantly reduced intralesional bleeding and heme levels, which are associated with tissue damage and inflammation.

TXA treatment led to decreased expression of the inflammatory markers TLR4 and TNF in microglial cells, resulting in improved functional recovery after SCI, suggesting its potential as a therapeutic option in the acute phase of spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid reduces heme cytotoxicity via the TLR4/TNF axis and ameliorates functional recovery after spinal cord injury. Yoshizaki, S., Kijima, K., Hara, M., et al.[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]

There is currently insufficient evidence to recommend the use of methylprednisolone for improving clinical outcomes in patients with thoracic and lumbar fractures and spinal cord injury.

The task force emphasized the importance of considering the potential complications associated with methylprednisolone administration before making treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines on the Evaluation and Treatment of Patients With Thoracolumbar Spine Trauma: Pharmacological Treatment. Arnold, PM., Anderson, PA., Chi, JH., et al.[2019]

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]

In a study of 46 patients with acute cervical spinal cord injury, high-dose methylprednisolone sodium succinate (MPSS) was associated with a higher rate of complications (56.5%) compared to placebo (34.8%), although this difference was not statistically significant.

Significantly more pulmonary complications (34.8% vs. 4.34%) and gastrointestinal complications (17.4% vs. 0%) were observed in the MPSS group, particularly in patients over 60 years old, indicating that older patients may require closer monitoring when receiving this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early complications of high-dose methylprednisolone sodium succinate treatment in the follow-up of acute cervical spinal cord injury. Matsumoto, T., Tamaki, T., Kawakami, M., et al.[2022]

In a study involving 620 patients (290 treated with dexamethasone and 330 as controls), those receiving dexamethasone showed greater improvement in recovery from acute spinal cord injuries compared to those who did not receive corticosteroids.

While dexamethasone treatment was effective, it was associated with a slight increase in complications like gastrointestinal bleeding and delayed wound healing, highlighting the need for careful monitoring when used shortly after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of dexamethasone in the treatment of acute spinal cord injury. Kiwerski, JE.[2019]

This pilot study aims to assess the safety and feasibility of administering oral glyburide to 10 patients with acute cervical spinal cord injury within 8 hours of injury, building on preclinical evidence that glyburide can reduce secondary injury effects like progressive hemorrhagic necrosis.

Glyburide is considered a promising neuroprotective strategy due to its potential to mitigate secondary injury mechanisms, despite the risk of hypoglycemia, making it an interesting addition to standard care for spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SCING-Spinal Cord Injury Neuroprotection with Glyburide: a pilot, open-label, multicentre, prospective evaluation of oral glyburide in patients with acute traumatic spinal cord injury in the USA. Minnema, AJ., Mehta, A., Boling, WW., et al.[2020]

The study investigated the relationship between TXA2 and PGI2 levels and secondary trauma following spinal cord injury using a rabbit model, providing insights into the biochemical changes that occur after injury.

Intra-arachnoid perfusion of dexamethasone and verapamil was evaluated for its effects on TXA2-PGI2 alterations, suggesting potential therapeutic interventions to mitigate secondary damage after spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intra-arachnoid space perfusion on thromboxane A and prostacycline in experimental spinal cord injury. Tu, Y., Du, J., Xia, Z., et al.[2019]

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 51 patients undergoing posterior spinal fusion for adult spinal deformity, the use of epsilon aminocaproic acid (EACA) significantly reduced total blood loss compared to placebo, highlighting its efficacy as an antifibrinolytic agent.

While both EACA and tranexamic acid (TXA) showed trends toward reduced intraoperative blood loss, EACA was more effective in lowering postoperative blood transfusion rates compared to TXA, suggesting it may be the preferred choice for minimizing blood loss in these surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antifibrinolytics reduce blood loss in adult spinal deformity surgery: a prospective, randomized controlled trial. Peters, A., Verma, K., Slobodyanyuk, K., et al.[2022]

Tranexamic acid (TXA) significantly reduces intraoperative blood loss, transfusion rates, and postoperative drainage volume in adolescent spinal corrective surgery, indicating its efficacy in this context.

The administration of TXA is generally safe, with no drug-related adverse events reported at doses ranging from 10-100 mg/kg for loading and 1-10 mg/(kg·h) for maintenance, although further research is needed to optimize these dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress on the application of tranexamic acid in adolescent spine corrective surgery]. Zhang, Z., Yang, X., Wang, L., et al.[2022]

Tranexamic acid (TXA) significantly reduces total and intraoperative blood loss during scoliosis surgery, based on a meta-analysis of 685 patients, indicating its efficacy as a treatment option.

There was no significant difference in the need for blood transfusions between the TXA and placebo groups, suggesting that while TXA helps control blood loss, it does not necessarily reduce transfusion requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tranexamic acid in reducing blood loss in scoliosis surgery: a systematic review and meta-analysis. Yuan, QM., Zhao, ZH., Xu, BS.[2018]

Topical tranexamic acid (TXA) significantly reduced postoperative blood loss in spine surgery patients compared to a placebo, with a large effect size (SMD 2.21) based on a review of 218 patients across six studies.

Patients receiving topical TXA also experienced shorter hospital stays, indicating its potential to improve recovery times in spinal surgery, although more research is needed to determine optimal dosing and pharmacodynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical tranexamic acid in spinal surgery: A systematic review and meta-analysis. Yerneni, K., Burke, JF., Tuchman, A., 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 ...

In our study, IV TXA also showed a reduction in most outcomes (intraoperative blood loss, postoperative blood loss, hemoglobin drop, and blood ...

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. However ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02063035

Effectiveness Study of the Drug Tranexamic Acid to ...

Intravenous tranexamic acid administration has been shown to reduce postoperative blood loss and transfusion need in patients undergoing spinal surgery ( ...

4.

josr-online.biomedcentral.com

josr-online.biomedcentral.com/articles/10.1186/s13018-024-04989-1

Intravenous versus topical tranexamic acid in spinal surgery

Our meta-analysis revealed that ivTXA was more effective than tTXA during spinal surgery and resulted in reduced TBL, IBL, HBL, and PBL and ...

5.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1405773/full

Efficacy and safety of tranexamic acid in cervical spine ...

The available evidence indicates that TXA effectively reduces blood loss in cervical spinal surgery while maintaining a favorable safety profile.

6.

pmc.ncbi.nlm.nih.gov

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

Safety and Efficacy of Tranexamic Acid in Spinal Surgery

TXA is effective in reducing intraoperative and overall blood loss in spinal surgery without increasing the risk of complications.

7.

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 ...

8.

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, ...

9.

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 ...