Spinal FusionPhase 3NCT03425799
Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
A Phase 3 study testing Sodium Chloride 0.9% Inj and Tranexamic Acid in people with Spinal Fusion, run by Exela Pharma Sciences, LLC. at 4 sites in United States.
Trial summary
The purpose of this study is to see if Tranexamic Acid can safely reduce bleeding in people undergoing spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusion
- What is being tested?
- Sodium Chloride 0.9% Inj and Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Oct 2018to 21 Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rush University Medical Center - Division of Spine Surgery
Chicago, Illinois, 60612
Memorial Orthopaedic Surgery Group
Long Beach, California, 90806
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Spine Care Orthopedics - NYU Lagone Medical Center
New York, New York, 10016
About this study
The purpose of this study is to see if Tranexamic Acid can safely reduce bleeding in people undergoing spinal fusion surgery.
Read the detailed description
This will be a multicenter, randomized, double-blind, parallel group study comparing tranexamic acid (test) to placebo (control) for reduction of perioperative blood loss after complex spinal fusion surgery (defined as T2 to Pelvis/Sacrum and greater than 4 Functional Spinal Units (4 discs/motion segments=5 Vertebral segments)). In addition to test and control treatments, all patients undergoing spinal fusion surgery will receive anesthesia and standard of care for blood loss including colloid/crystalloid fluid replacement and packed red cells, if necessary, according to a common multi-institutional protocol. Anesthesia will keep the mean arterial pressure as low as safe for the patient during exposure of surgery (estimated at 60-80 MAP). Patients will be randomized to receive either 30 mg/kg tranexamic acid as a one hour infusion (3 mL/kg) loading dose prior to start of procedure and as an infusion at 3 mg/kg/h (0.3 mL/kg/h) of tranexamic acid throughout the surgery in the test group; or, a one hour infusion at 3 mL/kg of 0.9% saline prior to start of the procedure and an infusion of 0.9% saline at 0.3 mL/kg/h in the control group. The maximum total dose will be 50 mg/kg.
The active phase of the study will be until discharge postoperatively for efficacy measurements and at 6 weeks for safety follow-up. The randomization will be open only to the statistician generating the randomization sequence. All PI(s), study conduct and monitoring staff, as well as the subjects will be completely blinded to the treatments except in the case of emergency.
The study will be terminated if ≥5/12 or 10/36 patients enrolled in the study are diagnosed with treatment related serious adverse events.
- Conditions
- Spinal Fusion
- Being tested
- Sodium Chloride 0.9% Inj, Tranexamic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Chloride 0.9% InjDrug
Also called Saline
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.
Tranexamic AcidDrug
Also called Tranexamic Acid in 0.7% sodium chloride
Tranexamic Acid Intravenous Infusion Bags (10 mg/mL), manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From time of surgery until discharge
Incidence of Autologous or Allogenic Blood Transfusion
Number of Units of autologous transfusion and allogenic transfusion
Measured: From time of surgery until discharge
Secondary outcomes (3)
Total Measured Blood Loss
Estimated as 3x cell saver
Measured: From time of surgery up to 24 hours after surgery
Number of Patients With Symptomatic Anemia Precipitated Transfusion
Number of patients with symptomatic anemia precipitated transfusion in each group
Measured: Until discharge
Number of Patients With Adverse Events Related to Tranexamic Acid
Number of patients with adverse events related to tranexamic acid in each group
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start17 Oct 2018
- Primary completion23 Oct 2019
- Study completion21 Jan 2020
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exela Pharma Sciences, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neel Anand, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425799
- Sponsor's protocol ID
- CP-006-2017
- Status last verified
- Sep 2020
- First submitted
- 23 Jan 2018
- Last updated
- 21 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT03425799
- Acronym / sponsor ID
- CP-006-2017
- Conditions
- Spinal Fusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Exela Pharma Sciences, LLC.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Posted 21 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if Tranexamic Acid can safely reduce bleeding in people undergoing spinal fusion surgery.
Detailed description
This will be a multicenter, randomized, double-blind, parallel group study comparing tranexamic acid (test) to placebo (control) for reduction of perioperative blood loss after complex spinal fusion surgery (defined as T2 to Pelvis/Sacrum and greater than 4 Functional Spinal Units (4 discs/motion segments=5 Vertebral segments)). In addition to test and control treatments, all patients undergoing spinal fusion surgery will receive anesthesia and standard of care for blood loss including colloid/crystalloid fluid replacement and packed red cells, if necessary, according to a common multi-institutional protocol. Anesthesia will keep the mean arterial pressure as low as safe for the patient during exposure of surgery (estimated at 60-80 MAP). Patients will be randomized to receive either 30 mg/kg tranexamic acid as a one hour infusion (3 mL/kg) loading dose prior to start of procedure and as an infusion at 3 mg/kg/h (0.3 mL/kg/h) of tranexamic acid throughout the surgery in the test group; or, a one hour infusion at 3 mL/kg of 0.9% saline prior to start of the procedure and an infusion of 0.9% saline at 0.3 mL/kg/h in the control group. The maximum total dose will be 50 mg/kg.
The active phase of the study will be until discharge postoperatively for efficacy measurements and at 6 weeks for safety follow-up. The randomization will be open only to the statistician generating the randomization sequence. All PI(s), study conduct and monitoring staff, as well as the subjects will be completely blinded to the treatments except in the case of emergency.
The study will be terminated if ≥5/12 or 10/36 patients enrolled in the study are diagnosed with treatment related serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Chloride 0.9% | Placebo comparator | Drug: Sodium Chloride 0.9% InjSodium 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 |
| Tranexamic Acid 10 mg/mL | Experimental | Drug: Tranexamic AcidTranexamic 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Chloride 0.9% InjAlso: SalineInactive 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. | Drug | Sodium Chloride 0.9% |
| Tranexamic AcidAlso: Tranexamic Acid in 0.7% sodium chlorideTranexamic Acid Intravenous Infusion Bags (10 mg/mL), manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot. | Drug | Tranexamic Acid 10 mg/mL |
Primary outcome
Total Blood Loss
Time frame: From time of surgery until discharge
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.
Incidence of Autologous or Allogenic Blood Transfusion
Time frame: From time of surgery until discharge
Number of Units of autologous transfusion and allogenic transfusion
3 secondary outcomes
Total Measured Blood Loss
Time frame: From time of surgery up to 24 hours after surgery
Number of Patients With Symptomatic Anemia Precipitated Transfusion
Time frame: Until discharge
Number of Patients With Adverse Events Related to Tranexamic Acid
Time frame: up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neel Anand, MD principal investigator
Cedars-Sinai Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Chloride 0.9% Inj and Tranexamic Acid in people with Spinal Fusion, run by Exela Pharma Sciences, LLC. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Blood Loss (time frame: From time of surgery until discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.