Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery

NCT03425799 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: CP-006-2017
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to see if Tranexamic Acid can safely reduce bleeding in people undergoing spinal fusion surgery.

Conditions

Spinal Fusion

Outcome Measures

Primary Outcomes (2)

• Total Blood Loss

  The Total Blood Loss will be estimated based on the hemoglobin content of the blood prior to surgery (mg/dL) and at each of the desired post-surgery time-points (mg/dL). Blood samples for hemoglobin measurement will be collected prior to start of procedure, at the end of the procedure, at 24 h, and every 24 h thereafter until discharge and removal two subfascial drains.

  From time of surgery until discharge

• Incidence of Autologous or Allogenic Blood Transfusion

  Number of Units of autologous transfusion and allogenic transfusion

  From time of surgery until discharge

Secondary Outcomes (3)

• Total Measured Blood Loss

  From time of surgery up to 24 hours after surgery

• Number of Patients With Symptomatic Anemia Precipitated Transfusion

  Until discharge

• Number of Patients With Adverse Events Related to Tranexamic Acid

  up to 6 weeks

Study Arms (2)

Sodium Chloride 0.9%

PLACEBO COMPARATOR

Sodium Chloride 0.9% 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

Drug: Sodium Chloride 0.9% Inj

Tranexamic Acid 10 mg/mL

EXPERIMENTAL

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

Drug: Tranexamic Acid

Interventions

Sodium Chloride 0.9% Inj DRUG

Inactive ingredient mixture for injection without drug, intravenous infusion bags containing normal saline, manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot.

Also known as: Saline

Sodium Chloride 0.9%

Tranexamic Acid DRUG

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

Also known as: Tranexamic Acid in 0.7% sodium chloride

Tranexamic Acid 10 mg/mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exela Pharma Sciences, LLC.: lead

Study Sites (4)

Memorial Orthopaedic Surgery Group

Long Beach, California, 90806, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Rush University Medical Center - Division of Spine Surgery

Chicago, Illinois, 60612, United States

Location

Spine Care Orthopedics - NYU Lagone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Sodium Chloride; Tranexamic Acid

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Aruna Koganti, VP Clinical Programs
• Organization: Exela Pharma Sciences

akoganti@exela.us

828-758-5474

Study Officials

• Neel Anand, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 8, 2018
• Study Start: October 17, 2018
• Primary Completion: October 23, 2019
• Study Completion: January 21, 2020
• Last Updated: June 21, 2021
• Results First Posted: June 21, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)