Intervention: Tranexamic acid
Trial phase: Phase 3
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Tranexamic Acid 10 mg/mL infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg

Tranexamic Acid: Tranexamic Acid Intravenous Infusion Bags (10 mg/mL), manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot.
Eligibility criteria:
Inclusion Criteria:

All adult patients (Male or Female) over age eighteen (>18) electively undergoing complex spinal fusion surgery (defined as T2 to Pelvis/Sacrum and greater than 4 Functional Spinal Units (4 discs/motion segments=5 Vertebral segments).
Female subjects of childbearing potential with a negative serum (beta human chorionic gonadotropin [HCG]) pregnancy test at screening and urine pregnancy test at each admission; who are not breastfeeding; do not plan to become pregnant during the course of the study; and agree to use an approved method of birth control, such as condoms, foams, jellies, diaphragm, intrauterine device, sexual abstinence for at least 3 months prior to study
Able to provide written informed consent after risks and benefits of the study have been explained
Able to communicate effectively with study personnel.

Exclusion Criteria:

History or presence of any clinically significant (based on the Investigator's judgment) cardiovascular, respiratory, metabolic, hepatic, gastrointestinal, renal, hematological, dermatological, neurological, or psychiatric disease or condition preventing the use of tranexamic acid
History of renal failure or elevated creatinine above 1.4
Any diagnosis of spinal tumor or intradural pathology
Diagnosis of ankylosing spondylitis
History or presence of acquired disturbance of color vision
History of seizures
History of thromboembolic event (DVT or PE) within the past year
Current use of anticoagulant medications or past medical history leading to an abnormal coagulation profile preoperatively
Subjects diagnosed with fibrinolytic disorders requiring intra-operative antifibrinolytic treatment; hematological disease (thromboembolic events, hemoglobinopathy, coagulopathy, or hemolytic disease)
Significant drug sensitivity or significant allergic reaction to any drug, including tranexamic acid, based on the Investigator's judgment
A subject who has donated or lost 450 mL or more blood volume (including plasmaphoresis) or had a transfusion of any product within 3 months prior to the initial study drug administration
Pre-operative anemia (hb <110 in females, Hb <120 in males)
Any subject that chooses to refuse blood products for ethical or religious purposes (Jehovah's Witness)
Current participation in a drug or other investigational research study or participation within 30 days prior to the initial study drug administration
A subject who may not be able to comply with the safety monitoring requirements of this clinical trial or is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Intraoperative cardiovascular, pulmonary, orthopedic, or anesthetic complication such as myocardial infarction, intraoperative fracture, vasopressor support or emergent intubation.
Female patients who are using combination hormonal contraception.
Patients with history of subarachnoid hemorrhage.
Patients with serum creatinine above upper limit of normal (ULN).