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Trial record 62 of 419 for:    TRANEXAMIC ACID

Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03425799
Recruitment Status : Enrolling by invitation
First Posted : February 8, 2018
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
Spinemark Corporation Inc.
Information provided by (Responsible Party):
Exela Pharma Sciences, LLC.

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

Condition or disease Intervention/treatment Phase
Spinal Fusion Drug: Sodium Chloride 0.9% Inj Drug: Tranexamic Acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Sodium Chloride 0.9%
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
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.

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




Primary Outcome Measures :
  1. Total Blood Loss [ Time Frame: From time of surgery up to 7 days after surgery ]
  2. Incidence of autologous or allogenic blood transfusion [ Time Frame: From time of surgery up to 7 days after surgery ]

Secondary Outcome Measures :
  1. Total Measured Blood Loss [ Time Frame: From time of surgery up to 24 hours after surgery ]
    Estimated as 3x cell saver

  2. Number of patients with symptomatic anemia precipitated transfusion [ Time Frame: up to 7 days ]
  3. Number of patients with adverse events related to tranexamic acid [ Time Frame: up to 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425799


Locations
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United States, California
Memorial Orthopaedic Surgery Group
Long Beach, California, United States, 90806
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Illinois
Rush University Medical Center - Division of Spine Surgery
Chicago, Illinois, United States, 60612
United States, New York
Spine Care Orthopedics - NYU Lagone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
Exela Pharma Sciences, LLC.
Spinemark Corporation Inc.

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Responsible Party: Exela Pharma Sciences, LLC.
ClinicalTrials.gov Identifier: NCT03425799     History of Changes
Other Study ID Numbers: CP-006-2017
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants