Degenerative Disc DiseasePhase 2NCT04272606
TXA in Spinal Fusion
A Phase 2 study testing Tranexamic Acid, Saline Solution and Visual Acuity Exam in people with Degenerative Disc Disease, run by Catherine R. Olinger at 1 site in United States.
Trial summary
Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Tranexamic Acid, Saline Solution and Visual Acuity Exam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 12 Jun 2023
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90 years
- American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV
- Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.
- Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.
Who cannot join
- ASA class V
- Patient unable to consent
- Patient with chronic kidney disease stage III or above: baseline plasma creatinine>1.5mg/dL
- Patient with known liver failure
- Patients on anticoagulation or dual antiplatelets (presence of vascular stents).
- Patients with artificial valves.
Show all 29Show fewer
- Patients with allergy to TXA
- Patients with platelet count < 150 000,
- Patients with PT>15s
- Patients with Activated Partial Thromboplastin Time (APPT) >38s
- History of stroke or (an) unprovoked thromboembolic event(s).
- History of intracranial bleeding,
- Pregnancy
- known defective color vision
- history of venous or arterial thromboembolism or active thromboembolic disease
- Patients with severe pulmonary or cardiac disease.
- Patients who refuse transfusion of blood products
- Patients with chronic anemia with Hg<8
- Patients undergoing lumbar fusion for disease other than DDD (neoplasm)
- Patients undergoing lumbar fusion by anterior or lateral approach.
- Minimally invasive TLIF are excluded.
- Emergent cases.
- Women on hormonal contraception
- Retinal vein or artery occlusion
- Hypercoagulability
- Seizure disorder
- Current use of tretinoin
- Current use of chlorpromazine
- Breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Prospective, Randomized, Double Blind Study on the Effects of Tranexamic Acid on Intraoperative Blood Loss During Lumbar Spinal Fusion And Instrumentation
Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.
Read the detailed description
This study is to assess whether tranexamic acid (a drug that is used to coagulate the blood and reduce bleeding) use in lumbar spinal fusion can reduce blood loss and postoperative delirium compared to placebo. Thusly reducing need for transfusion, shorting the hospital stay and improving outcomes. For this the study will randomize patients who are receiving elective lumbar interbody fusion (PLIF or TLIF) of 2 or more levels for degenerative disc disease (DDD) into 2 groups. Group 1 would receive tranexamic acid during the surgery while group 2 will receive placebo. Blood loss during the surgery and postoperatively (while the patient has a drain) will be monitored along with the amount of transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation, and and the duration of hospital stay. Delirium occurrence and severity will be assessed daily for the first 5 days after surgery or at discharge, whichever comes first. Cognitive status (neuropsychological tests) will be assessed at post-discharge follow up visits and compared to preoperative status.
The drug or placebo are only given during the surgery. The patient population includes elective cases of patient undergoing lumbar spinal fusion of 2 or more levels. Spinal fusions are known to be associated with blood loss, especially when the surgeries are long and more levels need to be fused.
- Conditions
- Degenerative Disc Disease
- Being tested
- Tranexamic Acid, Saline Solution, Visual Acuity Exam, 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
- Keywords
- Posterior Lumbar Interbody Fusion, Transforaminal Lumbar Interbody Fusion, Tranexamic Acid, Neurosurgery, Delirium
- Medical subject headings
- Intervertebral Disc Degeneration, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Cyklokapron
Antifibrinolytic Agent
Saline SolutionDrug
Placebo
Visual Acuity ExamDiagnostic test
Also called Eye Exam
Supplemented into standard of care daily neurological exam on day of surgery and day after
3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)Diagnostic test
3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | 1:1 randomization, given tranexamic acid during surgery, visual acuity exam Receives: Drug: Tranexamic Acid; Diagnostic Test: Visual Acuity Exam; Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) |
| Placebo | Placebo comparator | 1:1 randomization, given standard of care treatment during surgery, visual acuity exam Receives: Drug: Saline Solution; Diagnostic Test: Visual Acuity Exam; Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion
The number of participants who had red blood cells (RBC) transfused:
- Intraoperatively
- Postoperatively (prior to discharge or at day 5, whichever occurred first)
- Either Intraoperatively or Postoperatively
Measured: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Blood Loss
Amount of blood loss:
- Intraoperatively
- Postoperatively (prior to discharge or at day 5, whichever occurred first)
- Either Intraoperatively or Postoperatively
Measured: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Delirium Occurrence
Delirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument.
Measured: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Secondary outcomes (3)
Delirium Severity
Severity (score 0-20) using daily 3D-CAM delirium assessment instrument. Minimum=0 (no delirium) Maximum=20 (worse delirium)
Measured: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Change in Interleukin-6 Concentration.
Measure of systemic inflammation using Interleukin-6 change between preoperative and 24 postoperatively blood draw.
Measured: Preoperatively and 24 hours postoperatively
Length of Postoperative Stay Prior to Discharge
Length of postoperative stay prior to discharge in days
Measured: Days thru day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Aug 2020
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 2B randomized, single-center, double-blinded, placebo vs treatment clinical trial with 1:1 randomization
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine R. Olinger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Catherine R. Olinger, University of Iowa
- Investigators
- Catherine Olinger, M.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272606
- Sponsor's protocol ID
- 201912099
- Status last verified
- Nov 2024
- First submitted
- 13 Feb 2020
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hindman BJ, Olinger CR, Woodroffe RW, Zanaty M, Deifelt Streese C, Zacharias ZR, Houtman JCD, Wendt LH, Ten Eyck PP, O'Connell-Moore DJ, Ray EJ, Lee SJ, Waldschmidt DF, Havertape LG, Nguyen LB, Chen PF, Banks MI, Sanders RD, Howard MA 3rd. Exploratory randomised trial of tranexamic acid to decrease postoperative delirium in adults undergoing lumbar fusion-a trial stopped early. BJA Open. 2025 Apr 14;14:100403. doi: 10.1016/j.bjao.2025.100403. eCollection 2025 Jun.
PubMed 40276619
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double Blind Study on the Effects of Tranexamic Acid on Intraoperative Blood Loss During Lumbar Spinal Fusion And Instrumentation
- ClinicalTrials.gov ID
- NCT04272606
- Acronym / sponsor ID
- 201912099
- Conditions
- Degenerative Disc Disease
- Keywords
- Posterior Lumbar Interbody Fusion, Transforaminal Lumbar Interbody Fusion, Tranexamic Acid, Neurosurgery, Delirium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Catherine R. OlingerUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 14 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.
Detailed description
This study is to assess whether tranexamic acid (a drug that is used to coagulate the blood and reduce bleeding) use in lumbar spinal fusion can reduce blood loss and postoperative delirium compared to placebo. Thusly reducing need for transfusion, shorting the hospital stay and improving outcomes. For this the study will randomize patients who are receiving elective lumbar interbody fusion (PLIF or TLIF) of 2 or more levels for degenerative disc disease (DDD) into 2 groups. Group 1 would receive tranexamic acid during the surgery while group 2 will receive placebo. Blood loss during the surgery and postoperatively (while the patient has a drain) will be monitored along with the amount of transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation, and and the duration of hospital stay. Delirium occurrence and severity will be assessed daily for the first 5 days after surgery or at discharge, whichever comes first. Cognitive status (neuropsychological tests) will be assessed at post-discharge follow up visits and compared to preoperative status.
The drug or placebo are only given during the surgery. The patient population includes elective cases of patient undergoing lumbar spinal fusion of 2 or more levels. Spinal fusions are known to be associated with blood loss, especially when the surgeries are long and more levels need to be fused.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 2B randomized, single-center, double-blinded, placebo vs treatment clinical trial with 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Tranexamic Acid, Diagnostic Test: Visual Acuity Exam, Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)1:1 randomization, given tranexamic acid during surgery, visual acuity exam |
| Placebo | Placebo comparator | Drug: Saline Solution, Diagnostic Test: Visual Acuity Exam, Diagnostic Test: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)1:1 randomization, given standard of care treatment during surgery, visual acuity exam |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-90 years
- American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV
- Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.
- Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.
Key exclusion criteria (29 listed)
- ASA class V
- Patient unable to consent
- Patient with chronic kidney disease stage III or above: baseline plasma creatinine>1.5mg/dL
- Patient with known liver failure
- Patients on anticoagulation or dual antiplatelets (presence of vascular stents).
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 |
|---|---|---|
| Tranexamic AcidAlso: CyklokapronAntifibrinolytic Agent | Drug | Treatment |
| Saline SolutionPlacebo | Drug | Placebo |
| Visual Acuity ExamAlso: Eye ExamSupplemented into standard of care daily neurological exam on day of surgery and day after | Diagnostic test | Placebo, Treatment |
| 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium. | Diagnostic test | Placebo, Treatment |
Primary outcome
Transfusion
Time frame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
The number of participants who had red blood cells (RBC) transfused: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively
Blood Loss
Time frame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Amount of blood loss: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively
Delirium Occurrence
Time frame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Delirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument.
3 secondary outcomes
Delirium Severity
Time frame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Change in Interleukin-6 Concentration.
Time frame: Preoperatively and 24 hours postoperatively
Length of Postoperative Stay Prior to Discharge
Time frame: Days thru day of discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40276619Hindman BJ, Olinger CR, Woodroffe RW, Zanaty M, Deifelt Streese C, Zacharias ZR, Houtman JCD, Wendt LH, Ten Eyck PP, O'Connell-Moore DJ, Ray EJ, Lee SJ, Waldschmidt DF, Havertape LG, Nguyen LB, Chen PF, Banks MI, Sanders RD, Howard MA 3rd. Exploratory randomised trial of tranexamic acid to decrease postoperative delirium in adults undergoing lumbar fusion-a trial stopped early. BJA Open. 2025 Apr 14;14:100403. doi: 10.1016/j.bjao.2025.100403. eCollection 2025 Jun.
- 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.
Catherine Olinger, M.D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid, Saline Solution and Visual Acuity Exam in people with Degenerative Disc Disease, run by Catherine R. Olinger at 1 site 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 29 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: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 14 May 2024). 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?
Transfusion (time frame: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272606, which also lists 1 linked publication.
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 12 Dec 2024.