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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03425799
Ethics application status
Date submitted
23/01/2018
Date registered
8/02/2018
Date last updated
3/12/2018

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
Treatment: Drugs - Sodium Chloride 0.9% Inj
Treatment: Drugs - Tranexamic Acid

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

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


Treatment: Drugs: 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.

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total Blood Loss
Timepoint [1] 0 0
From time of surgery up to 7 days after surgery
Primary outcome [2] 0 0
Incidence of autologous or allogenic blood transfusion
Timepoint [2] 0 0
From time of surgery up to 7 days after surgery
Secondary outcome [1] 0 0
Total Measured Blood Loss - Estimated as 3x cell saver
Timepoint [1] 0 0
From time of surgery up to 24 hours after surgery
Secondary outcome [2] 0 0
Number of patients with symptomatic anemia precipitated transfusion
Timepoint [2] 0 0
up to 7 days
Secondary outcome [3] 0 0
Number of patients with adverse events related to tranexamic acid
Timepoint [3] 0 0
up to 6 weeks

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,TAS
Recruitment hospital [1] 0 0
Brian Hsu - Sydney
Recruitment hospital [2] 0 0
Calvary Hospital - Hobart
Recruitment postcode(s) [1] 0 0
2067 - Sydney
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Exela Pharma Sciences, LLC.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Spinemark Corporation Inc.
Address [1] 0 0
Country [1] 0 0

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/show/NCT03425799
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/show/NCT03425799