Tranexamic Acid for Spinal Deformity

Overseen By Jordan A Gruskay, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Anticoagulants

Disqualifiers: Renal insufficiency, Seizure disorder, Thromboembolic events, Coronary artery disease, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

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

Compensation: Varies

Number of Visits: 1

Duration: 1 week

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical specialties. Intravenous TXA (ivTXA) is routinely used at our institution for adult spinal deformity cases. Meanwhile, topical TXA (tTXA) is an attractive alternative/adjunct to ivTXA used with good results in orthopedic arthroplasty and cardiac surgery. To the investigators' knowledge, no data exists in the literature on the use of tTXA in either adult or pediatric spinal deformity surgery. The goal of this study is to determine the role tTXA has an adjunct to ivTXA in decreasing perioperative blood loss, drainage, transfusion requirements and length of stay following adult deformity spine surgery.

Do I need to stop my current medications for the trial?

The trial requires stopping certain medications. If you are on anticoagulation therapy (like Coumadin, Plavix, or LVX), you must stop them 3 days before surgery. If you take ASA 325, you need to stop it 10 days before surgery. The protocol does not specify other medications, so check with the trial team for more details.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain blood thinners (anticoagulants) like Coumadin, Plavix, and LVX at least 3 days before surgery, and aspirin (ASA 325) 10 days before surgery. If you are on these medications and cannot stop them, you may not be eligible to participate.

What safety data is available for Tranexamic Acid in spinal deformity treatment?

The safety of Tranexamic Acid (TXA) in spinal deformity treatment has been evaluated in several studies. A systematic review and meta-analysis focused on adult spinal deformity surgery found TXA to be safe and effective in reducing intra-operative blood loss. Another study on thoracolumbar burst fractures also assessed the safety of TXA, confirming its efficacy and safety in this context. Additionally, a randomized controlled trial examined different doses of TXA in minimally invasive lumbar fusion surgeries, further supporting its safety profile. The CRASH-2 trial, although not specific to spinal deformity, demonstrated the safety of TXA in reducing mortality in trauma patients, which is relevant to its overall safety profile. Lastly, a study on adolescent idiopathic scoliosis surgery also confirmed the safety of TXA in this patient group. ^{1 2 3 4 5}

Is tranexamic acid safe for use in humans?

Tranexamic acid (TXA) has been shown to be generally safe in various surgeries, including spinal deformity surgeries and trauma cases, with studies indicating it can reduce blood loss without significant safety concerns. ^{1 2 3 4 5}

Is the drug Tranexamic Acid a promising treatment for spinal deformity?

The articles provided do not directly discuss Tranexamic Acid as a treatment for spinal deformity. They focus on its use in reducing blood loss during surgeries and highlight potential risks if used incorrectly. Therefore, there is no information suggesting it is a promising treatment for spinal deformity. ^{6 7 8 9 10}

How does the drug tranexamic acid differ from other treatments for spinal deformity?

Tranexamic acid is unique in its use for spinal deformity as it primarily functions to reduce blood loss during surgery, which is not the main focus of other treatments for spinal deformity. It works by preventing the breakdown of blood clots, which can be particularly beneficial in surgeries that typically involve significant bleeding. ^{6 7 8 9 10}

What data supports the idea that Tranexamic Acid for Spinal Deformity is an effective treatment?

The available research shows that Tranexamic Acid (TXA) is effective in reducing blood loss during spinal surgeries. For example, studies on adolescent spinal deformity surgery and adult spinal deformity surgery both indicate that TXA helps minimize blood loss, which is a common concern during these procedures. This suggests that TXA is a beneficial drug for managing blood loss in spinal deformity surgeries. ^{1 2 11 12 13}

What data supports the effectiveness of the drug Tranexamic Acid for spinal deformity surgery?

Research shows that Tranexamic Acid (TXA) is effective in reducing blood loss during major spinal surgeries, including adolescent and adult spinal deformity surgeries, which involve correcting the spine's shape. This suggests that TXA can help manage blood loss in spinal deformity procedures, making it a useful drug in these surgeries. ^{1 2 11 12 13}

Who Is on the Research Team?

Han Jo Kim, MD

Principal Investigator

Department of Spine Surgery

Are You a Good Fit for This Trial?

Adults aged 18-80 scheduled for long spinal fusion surgery due to scoliosis or degenerative joint disease, who are not on certain blood thinners, without recent heart issues, bleeding disorders, severe anemia, color vision problems, active cancer or leukemia. They mustn't have renal or liver insufficiency, seizure history or thromboembolic events within the past year.

Inclusion Criteria

I am scheduled for a major spine surgery for scoliosis or joint disease, including fusion to the pelvis.

Exclusion Criteria

Preexisting anemia <10 g/dL

Pregnancy or women who are lactating/breastfeeding

My surgery will be done using the anterior approach.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spinal deformity surgery with administration of intravenous and/or topical tranexamic acid

1 week

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for blood loss, transfusion requirements, and adverse events

Up to 30 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The trial is testing if Tranexamic Acid (TXA), used topically as an add-on to its intravenous form can reduce blood loss and need for transfusions during adult spine deformity surgeries. It compares the effectiveness of topical TXA with a placebo in patients already receiving intravenous TXA.

How Is the Trial Designed?

Group I: ivTXA + topical TXA Experimental Treatment 1 Intervention

TXA lavage solution (200 cc sterile normal saline + 5 g tranexamic acid 100mg/ml (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after instrumentation. Excess solution will be suctioned away using a non-cell saver suction. IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2 mg/kg/hr maintenance dosing as per hospital protocol

Group II: IV TXA + topical placebo Placebo Group 1 Intervention

Placebo solution (200 cc sterile normal saline + placebo TXA ampule (normal saline) (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after pedicle screw instrumentation. Excess solution will be suctioned away using a non-cell saver suction. IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2mg/kg/hr maintenance dosing as per hospital protocol

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Published Research Related to This Trial

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]

Tranexamic acid (TXA) significantly reduces total blood loss, intraoperative blood loss, and postoperative blood loss in patients undergoing posterior lumbar fusion surgery, based on a meta-analysis of 9 studies with 713 patients.

TXA does not increase the risk of thrombotic events and shows no significant difference in blood transfusion rates, indicating it is a safe option for managing blood loss during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tranexamic acid usage in patients undergoing posterior lumbar fusion: a meta-analysis. Bai, J., Zhang, P., Liang, Y., et al.[2020]

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]

In a meta-analysis of 1148 patients from 17 studies, both high-dose and low-dose intravenous tranexamic acid (TXA) significantly reduced total blood loss, intraoperative blood loss, and blood transfusion rates during adolescent spinal deformity surgery, without increasing complications.

Low-dose TXA was particularly effective in shortening operative time, while high-dose TXA was associated with more vertebral fusion segments, indicating both dosing regimens have distinct benefits in surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Dose Regimens of Intravenous Tranexamic Acid in Adolescent Spinal Deformity Surgery: A Systematic Review and Meta-Analysis. Xiong, Z., Wu, K., Zhang, J., et al.[2022]

Tranexamic acid (TXA) is safe for use in adult spinal deformity surgery, showing no significant increase in thromboembolic events compared to placebo, based on a review of seven studies involving 339 patients.

TXA significantly reduced intraoperative blood loss by an average of 620.2 mL and total transfusion volumes by 958.2 mL, indicating its efficacy in managing blood loss during major spinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Tranexamic Acid in Adult Spinal Deformity Surgery: A Systematic Review and Meta-Analysis. Hariharan, D., Mammi, M., Daniels, K., et al.[2020]

In a study involving 116 patients undergoing single-level unilateral minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF), intravenous tranexamic acid (TXA) significantly reduced total blood loss (TBL) and hidden blood loss (HBL) in a dose-dependent manner compared to a placebo group.

The administration of TXA was found to be safe, with no increase in thrombotic complications such as deep venous thrombosis or pulmonary embolism observed in any of the treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prospective randomized controlled trial on the effectiveness of low-dose and high-dose intravenous tranexamic acid in reducing perioperative blood loss in single-level minimally invasive transforaminal lumbar interbody fusion]. Zhang, D., Wu, X., Kong, Q., et al.[2022]

In a study of 273 adult trauma patients receiving tranexamic acid (TXA) at a U.S. Level I trauma center, the overall mortality rate within 28 days was 12.8%, which is comparable to the 14.5% mortality rate observed in the CRASH-2 trial, indicating that TXA is effective in reducing mortality in traumatic hemorrhage.

However, the incidence of acute thromboembolic events was higher in this cohort at 6.6%, compared to 2.0% in the CRASH-2 trial, suggesting that while TXA is beneficial, it may also carry a higher risk of thromboembolic complications in certain patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality and Complication Rates in Adult Trauma Patients Receiving Tranexamic Acid: A Single-center Experience in the Post-CRASH-2 Era. Erramouspe, PJ., García-Pintos, MF., Benipal, S., et al.[2020]

Tranexamic acid (TXA) significantly reduces intraoperative blood loss and the need for blood transfusions in patients undergoing corrective surgery for adolescent idiopathic scoliosis, based on a review of 12 studies with 2500 patients.

TXA also shortens surgical time without increasing the risk of complications, such as renal or thromboembolic events, and does not affect postoperative hemoglobin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Perioperative Efficacy and Safety of Tranexamic Acid in Adolescent Idiopathic Scoliosis. Zhong, J., Cao, K., Wang, B., et al.[2020]

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]

The study reviewed the outcomes of T2 pedicle subtraction osteotomy (PSO) in four male patients (ages 55-72) with rigid cervicothoracic kyphotic deformity, showing significant improvements in spinal alignment without any neurological complications.

T2 PSO presents a safer alternative to C7 or T1 PSO, as it reduces the risk of nerve root injury and vertebral artery damage, while allowing for effective correction of kyphosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The case for T2 pedicle subtraction osteotomy in the surgical treatment of rigid cervicothoracic deformity. Yuk, FJ., Rasouli, JJ., Arginteanu, MS., et al.[2020]

A one-stage single-level pedicle subtraction osteotomy (PSO) combined with Ponte osteotomy (PO) effectively corrected a high kyphotic angle of 57.8 degrees in two patients with ankylosing spondylitis (AS) without causing neurological deficits, demonstrating its safety and efficacy.

The procedure resulted in less blood loss (maximum 1000 cc) compared to traditional two-level PSO methods, suggesting that this combined approach may be a safer alternative for treating high-angle thoracolumbar kyphotic deformities in AS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome evaluation in ankylosing spondylitis with high-angle thoracolumbar kyphotic deformity corrected by one-stage single-level pedicle subtraction osteotomy augmented with Ponte osteotomy: A case series. Oktavia, D., Airlangga, PA., Hidayat, AR., et al.[2023]

Surgical correction of posttraumatic kyphotic deformities in the thoracolumbar spine is a viable option when conservative treatments fail, particularly since these deformities are often limited to a few segments.

The choice of surgical approach—either purely posterior or combined posteroanterior—depends on the rigidity and location of the deformity, each offering unique benefits and drawbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Posttraumatic deformity of the thoracolumbar spine]. Pishnamaz, M., Scholz, M., Trobisch, PD., et al.[2020]

In a study of 34 patients with late post-traumatic thoracolumbar kyphosis, surgery effectively halted the progression of deformity in 33 patients, demonstrating a high success rate for spinal fusion procedures.

The surgical approaches varied, including anterior and posterior fusions, with many patients also receiving spinal cord decompression, indicating a comprehensive strategy to address both structural and neurological issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical reconstruction of late post-traumatic thoracolumbar kyphosis. Roberson, JR., Whitesides, TE.[2019]

Citations

1. Netherlands 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tranexamic acid usage in patients undergoing posterior lumbar fusion: a meta-analysis. [2020]

3. China pubmed.ncbi.nlm.nih.gov

[Progress on the application of tranexamic acid in adolescent spine corrective surgery]. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Different Dose Regimens of Intravenous Tranexamic Acid in Adolescent Spinal Deformity Surgery: A Systematic Review and Meta-Analysis. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Tranexamic Acid in Adult Spinal Deformity Surgery: A Systematic Review and Meta-Analysis. [2020]

6. China pubmed.ncbi.nlm.nih.gov

[Prospective randomized controlled trial on the effectiveness of low-dose and high-dose intravenous tranexamic acid in reducing perioperative blood loss in single-level minimally invasive transforaminal lumbar interbody fusion]. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Mortality and Complication Rates in Adult Trauma Patients Receiving Tranexamic Acid: A Single-center Experience in the Post-CRASH-2 Era. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The Perioperative Efficacy and Safety of Tranexamic Acid in Adolescent Idiopathic Scoliosis. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Ventriculolumbar perfusion and inhalational anesthesia with sevoflurane in an accidental intrathecal injection of tranexamic acid: unreported treatment options. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The case for T2 pedicle subtraction osteotomy in the surgical treatment of rigid cervicothoracic deformity. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term outcome evaluation in ankylosing spondylitis with high-angle thoracolumbar kyphotic deformity corrected by one-stage single-level pedicle subtraction osteotomy augmented with Ponte osteotomy: A case series. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

[Posttraumatic deformity of the thoracolumbar spine]. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Surgical reconstruction of late post-traumatic thoracolumbar kyphosis. [2019]