Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03425799




Registration number
NCT03425799
Ethics application status
Date submitted
23/01/2018
Date registered
8/02/2018
Date last updated
21/06/2021

Titles & IDs
Public title
Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
Scientific title
Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
Secondary ID [1] 0 0
CP-006-2017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Fusion 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/01/2020
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Exela Pharma Sciences, LLC.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to see if Tranexamic Acid can safely reduce bleeding in people undergoing spinal fusion surgery.
Trial website
https://clinicaltrials.gov/study/NCT03425799
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Neel Anand, MD
Address 0 0
Cedars-Sinai Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03425799