Tranexamic Acid for Spinal Injury
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Columbia University
Must not be taking: Anticoagulants, NSAIDs, Factor IX
Disqualifiers: Age <18 or >80, Sepsis, Pregnancy, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements.
The proposed study will be a prospective, randomized, double-blind (subject, surgeons, investigators, research coordinators) placebo-controlled study. Patients following high energy trauma who have sustained thoracic or lumbar spine fractures, dislocations or ligamentous injury with resultant instability requiring posterior spinal fusion will be enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery will also be enrolled. Both populations of patients will be randomized into two groups. Group I will receive standard of care operative fixation with topical tranexamic acid intervention (test); Group II will receive standard of care operative fixation with normal saline (placebo) intervention. This study will have a 2-year follow-up and will consist of three periods: screening/enrollment phase up to 21 days from the day of injury to the day of randomization and operative intervention, an inpatient data collection period for 4 days postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 2 week, 16 week, 1 year, and 2 year) time points.
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.
What data supports the effectiveness of the drug Tranexamic Acid (TXA) for spinal injury?
Research suggests that Tranexamic Acid (TXA) can reduce bleeding after physical trauma, which may help in managing spinal cord injuries where bleeding is a concern.
12345Is tranexamic acid generally safe for humans?
Tranexamic acid (TXA) is generally used to reduce bleeding in trauma and surgeries, but accidental injection into the spine can be dangerous, causing heart and nerve problems. This highlights the importance of correct administration to ensure safety.
46789How does the drug tranexamic acid differ from other treatments for spinal injury?
Tranexamic acid is unique because it is an antifibrinolytic drug that helps reduce blood loss during surgery by preventing the breakdown of blood clots. Unlike other treatments, it can be administered topically, which may reduce the risk of severe side effects associated with intravenous administration.
1011121314Eligibility Criteria
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
+21 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: InterventionActive Control1 Intervention
Subjects will receive tranexamic acid on the surgical wound.
Group II: Placebo controlPlacebo Group1 Intervention
Subjects will receive placebo (saline solution) on the surgical wound.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYP/The Allen Hospital - CUMCNew York, NY
Madigan Army Medical CenterTacoma, WA
University of California San Francisco Medical CenterSan Francisco, CA
NYP/The Allen Hospital - CUIMCNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
References
Early complications of high-dose methylprednisolone sodium succinate treatment in the follow-up of acute cervical spinal cord injury. [2022]A prospective, randomized, and double-blind study comparing high-dose methylprednisolone sodium succinate (MPSS) with placebo, in the treatment of patients with acute cervical spinal cord injury.
Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines on the Evaluation and Treatment of Patients With Thoracolumbar Spine Trauma: Pharmacological Treatment. [2019]Does the administration of a specific pharmacologic agent (eg, methylprednisolone) improve clinical outcomes in patients with thoracic and lumbar fractures and spinal cord injury?
Tranexamic acid reduces heme cytotoxicity via the TLR4/TNF axis and ameliorates functional recovery after spinal cord injury. [2023]Spinal cord injury (SCI) is a catastrophic trauma accompanied by intralesional bleeding and neuroinflammation. Recently, there is increasing interest in tranexamic acid (TXA), an anti-fibrinolytic drug, which can reduce the bleeding volume after physical trauma. However, the efficacy of TXA on the pathology of SCI remains unknown.
Ventriculolumbar perfusion and inhalational anesthesia with sevoflurane in an accidental intrathecal injection of tranexamic acid: unreported treatment options. [2022]Tranexamic acid (TXA) decreases hemorrhage-related mortality in trauma patients and is increasingly being used during obstetric and orthopedic surgeries. Inadvertent intrathecal injection of TXA is a rare, potentially lethal event leading to dose-dependent cardiotoxicity and neurotoxicity. TXA enhances neuronal excitation by antagonizing inhibitory γ-aminobutyric acid type A and glycine receptors. Until now, mechanistic-based pharmacological treatments targeting multiple central nervous system receptors have been advocated for use in such cases, with no data on intrathecal TXA elimination techniques.
Application of dexamethasone in the treatment of acute spinal cord injury. [2019]This communication evaluates the clinical efficacy of dexamethasone in acute spinal cord injury. The results of treatment in 290 patients given dexamethasone were compared with those of the control group of 330 patients not treated with corticosteroids. Patients with complete injuries and those with incomplete injuries showed greater improvement both quantitatively and qualitatively after treatment with dexamethasone than those without corticosteroids. The slightly increased risk of complications such as gastrointestinal bleeding and delayed wound healing was noted. It is recommended that corticosteroids should be used within the first hours after spinal cord injury.
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. [2020]Acute traumatic spinal cord injury (tSCI) is a devastating neurological disorder with no pharmacological neuroprotective strategy proven effective to date. Progressive haemorrhagic necrosis (PHN) represents an increasingly well-characterised mechanism of secondary injury after tSCI that negatively impacts neurological outcomes following acute tSCI. Preclinical studies evaluating the use of the Food and Drug Administration-approved sulfonylurea receptor 1-transient receptor potential melastatin 4 channel blocker glyburide in rodent models have shown reduced secondary microhaemorrhage formation and the absence of capillary fragmentation, the pathological hallmark of PHN.
Effect of BAY U 3405, a new thromboxane antagonist, on arachidonic acid induced thromboembolism. [2013]The model of AA-induced sudden death employed in these investigations seems to be appropriate for studying the efficacy of TXA2-antagonists. The actions of TXA2 on platelets, respiratory and vascular tissue are considered as key events resulting in the death of the animals. The results obtained in this study, using BAY U 3405 as a selective TXA2 receptor antagonist, clearly show that TXA2 mediated processes are effectively abolished by this type of drug. Since TXA2 is implicated in the pathophysiology of many diseases, potent TXA2 antagonists appear to be useful for treatment of these disorders. BAY U 3405 seems to fulfil these requirements. The threshold dose is 1 to 3 mg/kg p.o. In addition, there is a rapid onset and long duration of action at 10 mg/kg p.o. under the experimental conditions used.
Effectiveness of Riluzole as a pharmacotherapeutic treatment option for early cervical myelopathy: a double-blinded, placebo-controlled randomised controlled trial. [2018]To evaluate the effectiveness of Riluzole as a pharmacotherapeutic treatment option for early cervical myelopathy using clinical parameters and DTI analysis.
Effect of intra-arachnoid space perfusion on thromboxane A and prostacycline in experimental spinal cord injury. [2019]In order to understand the relation between TXA2-PGI2 and secondary trauma and the effect of intra-arachnoid perfusion of dexamethasone and verapamil on alteration of TXA2-PGI2 following spinal cord injury, TXB2 and 6-keto-PGF alpha concentration and pathological changes in injured site 1, 2, 4, and 6 h after injury were studied using a rabbit spinal cord injury model by Allen's weight drop method.
Efficacy and safety of tranexamic acid in reducing blood loss in scoliosis surgery: a systematic review and meta-analysis. [2018]The purpose of this systematic review and meta-analysis of randomized controlled trials (RCTs) and non-RCTs was to gather data to evaluate the efficacy and safety of tranexamic acid (TXA) versus placebo after a scoliosis surgery.
The efficacy and safety of multiple-dose intravenous tranexamic acid in reducing perioperative blood loss in patients with thoracolumbar burst fracture. [2021]To evaluate the efficacy and safety of tranexamic acid (TXA) for single-segment thoracolumbar burst fracture without neurologic injury underwent pedicle screw fixation via Wiltse approach.
Topical tranexamic acid in spinal surgery: A systematic review and meta-analysis. [2019]Tranexamic acid (TXA) is a commonly used antifibrinolytic agent for perioperative blood conservation in several surgical specialties. Although historically administered intravenously, such systemic administration may be accompanied by severe side effects. Thus, the topical usage of TXA has been established in several fields but remains poorly evaluated in spine surgery. In this study, the authors aimed to review the medical literature on topical TXA usage in spine surgery to evaluate its safety and efficacy. We reviewed manuscripts and clinical trials exploring topical TXA usage in spine surgery published by April 1st, 2018. Postoperative blood loss volumes and hospitalization lengths of stay were evaluated with separate meta-analyses. We identified five articles and one unpublished clinical trial that were placebo-controlled and comprised 218 patients receiving topical TXA in spine surgery. Patients receiving topical TXA demonstrated significantly lower postoperative blood loss as compared to the placebo group (Standardized Mean Difference [SMD] 2.21, 95% CI 0.79-3.62, p
Antifibrinolytics reduce blood loss in adult spinal deformity surgery: a prospective, randomized controlled trial. [2022]This is a prospective, randomized, double-blinded comparison of tranexamic acid (TXA), epsilon aminocaproic acid (EACA), and placebo used intraoperatively in patients with adult spinal deformity.
[Progress on the application of tranexamic acid in adolescent spine corrective surgery]. [2022]To review the advances in the application of tranexamic acid (TXA) in adolescent spinal corrective surgery.