Tranexamic Acid for Spine Surgery Patients
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Rush University Medical Center
Must not be taking: Anticoagulants
Disqualifiers: Pregnancy, Breastfeeding, Thromboembolic disease, others
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose and method of delivery regardless of their pre-operative risk of transfusion. Therefore, the aim of the study is to determine whether or not repeated dosing of oral or different method of delivery like intravenous (IV) TXA reduces the postoperative reduction in hemoglobin, hematocrit, number of transfusions, and postoperative blood loss following open spine surgery. The regimen that utilizes multiple doses of oral TXA will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regimen. Furthermore, oral TXA will be as efficacious as intravenous delivery of TXA.
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.
What data supports the effectiveness of the drug Tranexamic Acid for spine surgery patients?
Research shows that Tranexamic Acid (TXA) is effective in reducing blood loss during spine surgeries, such as those for thoracolumbar burst fractures and adolescent idiopathic scoliosis. It is widely used as an antifibrinolytic agent (a drug that prevents the breakdown of blood clots) in these procedures.
12345Is tranexamic acid generally safe for humans?
Tranexamic acid (TXA) is generally considered safe for use in humans, but there is a rare risk of serious side effects if it is accidentally injected into the spinal canal, which can lead to heart and nerve problems.
678910How is the drug Tranexamic Acid unique for spine surgery patients?
Tranexamic Acid (TXA) is unique for spine surgery patients because it is an antifibrinolytic agent that helps reduce blood loss during surgery, which is a common issue in these procedures. Unlike other treatments, TXA is specifically used to minimize the need for blood transfusions by preventing the breakdown of blood clots, although the optimal dosing for complex surgeries is still being studied.
23111213Eligibility Criteria
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.
+11 more
Trial Timeline
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)
Participant Groups
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.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 4 Full Oral TXAExperimental Treatment1 Intervention
Group II: Group 3 Pre-Oral TXAExperimental Treatment2 Interventions
Group III: Group 2 IV TXAExperimental Treatment2 Interventions
Group IV: Group 1 PLACEBOPlacebo Group1 Intervention
Tranexamic Acid is already approved in United States, European Union, Canada, Japan, Australia 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
🇦🇺 Approved in Australia as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rush University Medical CenterChicago, IL
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Who Is Running the Clinical Trial?
Rush University Medical CenterLead Sponsor
References
The efficacy and safety of tranexamic acid in lumbar surgery: A meta-analysis of randomized-controlled trials. [2022]This meta-analysis aims to assess tranexamic acid (TXA) effectiveness and safety in lumbar surgery.
Safety and Efficacy of High-Dose Tranexamic Acid in Spine Surgery: A Retrospective Single-Institution Series. [2023]Currently, tranexamic acid (TXA) is the most widely used antifibrinolytic agent in spine surgery and has been proven to reduce perioperative blood loss. However, the safety of high-dose regimens remains in established.
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.
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. [2023]The administration of tranexamic acid (TXA) has been shown to be beneficial in reducing blood loss during surgery for adolescent idiopathic scoliosis (AIS), but optimal dosing has yet to be defined. This retrospective study compared high- versus low-dose TXA as part of a Patient Blood Management strategy for reducing blood loss in patients undergoing posterior spine fusion surgery.
The Efficiency of Simultaneous Systemic and Topical Use of Tranexamic Acid in Spinal Fusion Surgery. [2022]Multilevel posterior spinal fusion surgery in adults is associated with significant intra- and postoperative blood loss. Tranexamic acid (TXA) is an antifibrinolytic agent for reducing blood loss and allogenic blood transfusion. The purpose of this study was to evaluate the efficiency of TXA in reducing blood loss and improving hematologic parameters in adult patients undergoing posterior thoracic/lumbar instrumented spinal fusion surgery.
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.
The protective effects of paclitaxel on platelet aggregation through the inhibition of thromboxane A2 synthase. [2015]Paclitaxel is an anticancer drug used in the treatment of ovarian, breast, head and neck, lung, and prostate cancer. We investigated the antiplatelet activity of paclitaxel in vitro as well as a possible antiplatelet mechanism. Paclitaxel inhibited washed rabbit platelet aggregation induced by collagen in a concentration dependent manner, with an IC(50) of 59.7 +/- 3.5. However, it had little effect on platelet aggregation mediated by arachidonic acid, U46619, a thromboxane (TX) A(2) mimic, or thrombin, suggesting that paclitaxel may strongly inhibit collagen mediated signal transduction. In accordance with these findings, paclitaxel blocked collagen induced cytosolic calcium mobilization, arachidonic acid liberation, and serotonin secretion. In addition, it inhibited arachidonic acid mediated platelet aggregation by about 37% by interfering with TXA(2) synthase as measured by the formation of arachidonic acid mediated TXA(2) and prostaglandin D(2), as well as cyclooxygenase-1 and TXA(2) synthase activity assays. Taken together, these results point to a cellular mechanism for the antiplatelet activity of paclitaxel through the inhibition of TXA(2) synthase and cytosolic calcium mobilization. This may contribute to the beneficial effects of paclitaxel on the cardiovascular system.
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.
G(12/13) signaling pathways substitute for integrin αIIbβ3-signaling for thromboxane generation in platelets. [2021]We have previously shown that ADP-induced TXA(2) generation requires signaling from αIIbβ3 integrin in platelets. Here we observed that, unlike ADP, protease-activated receptor (PAR)-mediated TXA(2) generation occurs independently of αIIbβ3. PAR agonists, but not ADP, activate G(12/13) signaling pathways. Hence, we evaluated the role of these pathways in TXA(2) generation.
The stable analog carbocyclic TXA2 but not platelet-released TXA2 induces osteoclast-like cell formation. [2019]Thromboxan A(2) (TXA(2)) is the main product of arachidonic acid metabolism in activated platelets. Platelet-released supernatants (PRS) can induce osteoclast-like cell formation in murine bone marrow cultures via a cyclooxygenase (COX)/receptor activator of NF-kB-ligand (RANKL)-dependent pathway. Here we investigated a possible linkage between platelet-released TXA(2) and osteoclastogenesis. The stable analog of TXA(2), carbocyclic TXA(2) (CTXA(2)) can induce the formation of tartrate-resistant acid phosphatase positive multinucleated cells in murine bone marrow cultures via a RANKL-dependent pathway and requires the presence of stromal cells. Interestingly, the platelet-released instable TXA(2) does not account for osteoclastogenic effects as: (a) PRS-induced osteoclastogenesis in the presence of the TXA(2) receptor antagonist SQ29548; (b) inhibition of platelet TXA(2) synthesis by indomethacin and acetylsalicylic acid failed to decrease the osteoclastogenic potential of the corresponding supernatants; and (c) CTXA(2)-induced osteoclast-like cell formation independent of indomethacin and the selective COX-2 inhibitor NS398.
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. [2022]For adults undergoing complex, multilevel spinal surgery, tranexamic acid (TXA) is an antifibrinolytic agent used to reduce blood loss. The optimal dosing of intravenous TXA remains unclear. This systematic review and meta-analysis compare various dosing regimens of intravenous TXA used in patients undergoing multilevel spine surgery (≥2 levels).
Does Tranexamic Acid Reduce Perioperative Bleeding in Short Segment Pedicle Screw Fixation in Thoracolumbar Spine Fractures? [2017]Blood loss with spinal surgery is common potential cause of morbidity and often requires blood transfusion. Tranexamic acid (TXA), is effective in reducing bleeding in patients undergoing knee arthroplasty. TXA used in spine surgery studies have included different cases leading to inconsistence of surgical procedures. Purpose of this prospective observational study was to examine effect of TXA decreasing bleeding in short segment pedicle screw fixation for thoracolumbar fractures.
Anaphylactic Reaction to Tranexamic Acid During Posterior Spinal Fusion: A Case Report. [2023]We present a 20-year-old man who suffered anaphylactic shock during posterior spinal fusion for neuromuscular scoliosis with the offending agent later identified via intradermal testing to be tranexamic acid (TXA).