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Spinal InjuriesPhase 2/3NCT02314988

Tranexamic Acid to Reduce Blood Loss in Spine Surgery

A Phase 2/3 study testing Tranexamic Acid in people with Spinal Injuries and Spinal Deformity, run by Columbia University at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Spinal Injuries, Spinal Deformity
What is being tested?
Tranexamic Acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
252 participants
Where
4 sitesUnited States
Study dates
15 Jun 2020to Jul 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation
  • Surgical fixation to be performed within 21 days of injury
  • Adult patients undergoing long segment (>5 fusion levels) posterior spinal fusions

Who cannot join

  • Age <18 or >80 years old
  • Severe soft tissue disruption around planned surgical site preventing adequate primary wound closure
  • Physiologic instability or ongoing sepsis/infection
  • Use of intravenous tranexamic acid during the pre-study period
  • Ballistic spinal column injury
  • Allergy to tranexamic acid
Show all 24Show fewer
  • Disturbances of color vision or color blindness
  • Pre-operative hemoglobin value of <7 g/dL, or <10 g/dL if patient has comorbidities or symptoms which will require pre-operative allogeneic blood transfusion
  • Refusal to consent for blood products
  • Participation in another clinical trial
  • Moderate or severe traumatic brain injuries that do not allow participation in individual patient outcomes surveys
  • Subarachnoid hemorrhage, anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by TXA
  • Concomitant use of Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased
  • Preoperative use of anticoagulant therapy (heparin, low-molecular weight heparin, warfarin) within three days before surgery, or non-steroid inflammatory medication (aspirin, ibuprofen, naprosyn) use within seven days before surgery
  • Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment
  • Disseminated intravascular coagulation (DIC)
  • Coagulopathy (as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.4, or a prolonged partial thromboplastin time >1.4 times normal)
  • History of arterial or venous thromboembolic disease (such as a cerebrovascular accident, deep-vein thrombosis, or pulmonary embolus), as these patients may be at increased risk for venous or arterial thrombosis
  • Upper urinary tract or ureteral injury (ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported)
  • Pregnancy or breastfeeding (Category B)
  • Substantial renal dysfunction (as assessed by a serum creatinine > 1.5 or calculated creatinine clearance of < 50) or hepatic failure
  • Major co-morbidities: alcohol or drug abuse, illnesses that affect bone or calcium metabolism, connective tissue disorders, coronary artery disease, severe ischemic heart disease [New York Heart Association Class III or IV], previous myocardial infarction, severe pulmonary disease [forced expiratory volume <50% of normal], diabetes mellitus (Type I or Type II), immunosuppression, peripheral vascular disease, severe penetrating or hemorrhagic traumatic brain injury, a history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton.
  • History of seizure or convulsive disorders, or currently concomitant use of other medications that are known to reduce seizure threshold
  • History of dural tear or open subdural space

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ronald A Lehman, MD contact

2129325067

rl2781@cumc.columbia.edu

Matthew J. Cooney contact

mc5386@cumc.columbia.edu

United States4 sites, 4 recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Christopher Shaffrey, MD

    Recruiting

  • Norton Leatherman Spine Center

    Louisville, Kentucky, 40202

    Charles H. Crawford, MD

    Recruiting

  • NYP/The Allen Hospital - CUIMC

    New York, New York, 10032

    Ronald A. Lehman, MD, rl2781@cumc.columbia.edu

    Ronald A. Lehman, MD

    Recruiting

  • University of California San Francisco Medical Center

    San Francisco, California, 94149

    Shane Burch, MD

    Recruiting

Other trials in United States

About this study

Official title: Topical Application of Tranexamic Acid (CYKLOKAPRON®) to Reduce Blood Loss During Spine Surgery

This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements.

The proposed study will be a prospective, randomized, double-blind (subject, surgeons, investigators, research coordinators) placebo-controlled study. Patients requiring posterior spinal fusion will be enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery will also be enrolled. Both populations of patients will be randomized into two groups. Group I will receive standard of care operative fixation with topical tranexamic acid intervention (test); Group II will receive standard of care operative fixation with normal saline (placebo) intervention. This study will have a 2-year follow-up and will consist of three periods: screening/enrollment phase up to 21 days from the day of injury to the day of randomization and operative intervention, an inpatient data collection period for 4 days postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 16 weeks, 1 year, and 2 year) time points.

Read the detailed description

Reducing perioperative blood loss is critically important in the treatment of multiply injured combat casualties, and major blood loss during complex spine trauma surgery is a significant concern. Similar to previous studies in dental, cardiac, and total knee arthroplasty procedures, the use of topical tranexamic acid during complex combat related spine trauma surgery can be a cost-effective and simple route of administration to reduce blood loss, with no significant systemic effects. Patients would be expected to benefit immediately by decreasing blood loss and the need for blood transfusion postoperatively, thereby exposing them to less risk of transfusion reactions or disease transmission. This may also potentially decrease the rate of surgical site infection because patients have been found to have a significantly increased risk for surgical site infection after blood transfusion due to changes in the immune system, and by also decreasing the amount of blood that collects under the surgical wound, which serves as excellent medium for bacterial growth. The goal of the investigators study is to determine if the use of topical tranexamic acid (TXA) in the setting of complex spine surgery reduces blood loss, and subsequently reduces the rate of allogenic blood transfusion and surgical site infection.

Being tested
Tranexamic Acid, Placebo
Keywords
Tranexamic acid, Antifibrinolytic, Perioperative blood loss, Postoperative drain output, Allogenic transfusion
Medical subject headings
Spinal Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic AcidDrug

    Also called Cyclokapron, TXA

    3.0 grams of tranexamic acid will be poured in the surgical field and left in contact for five minutes. Subsequently, excess study solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation.

    TXA solution will be prepared using a dose of 3 grams of tranexamic acid combined with 70 mL of sterile normal saline, for a total volume of 100 mL.

  • PlaceboDrug

    Also called Saline Solution

    Placebo will be poured in the surgical field and left in contact for five minutes. Subsequently, excess solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation.

    The placebo solution will be 100 mL of sterile normal saline.

Study groups in NCT02314988
Study groupRoleWhat they receive
InterventionActive comparatorSubjects will receive tranexamic acid on the surgical wound.
Receives: Drug: Tranexamic Acid
Placebo controlPlacebo comparatorSubjects will receive placebo (saline solution) on the surgical wound.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal drop in systemic hemoglobin concentration during the postoperative period

    Measured: Patients will be followed through postoperative day 4

Secondary outcomes (5)

  1. Reduction in the rate of surgical site infections

    Defined by decreasing the allogenic transfusion rate (an independent risk factor for surgical site infections) as well as by decreasing the formation of postoperative hematoma (a nidus for infection).

    Measured: Duration of the hospital stay (an average of 2 weeks), first postoperative wound check visit

  2. Number of complications

    Defined as thromboembolic event, including deep vein thrombosis (DVT) or pulmonary embolism (PE)

    Measured: Up to postoperative day 4

  3. Systemic absorption of locally applied drug

    Measured: Baseline (pre-surgery), immediately after administration of the topical agent, 1 hour after administration

  4. Patient assessed health-related quality of life score

    This will be determined by a questionnaire/score

    Measured: Up to 2 years postoperation

  5. Difference in costs for hospital stay between using tranexamic acid and placebo

    Patient cost information will be gathered for the duration of the hospital stay

    Measured: Duration of the hospital stay (an average of 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2014 (estimated)
  2. Study start15 Jun 2020
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02314988
Sponsor's protocol ID
AAAQ6795
Other IDs
201409111
Status last verified
May 2026
First submitted
3 Dec 2014
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tranexamic Acid in people with Spinal Injuries and Spinal Deformity, run by Columbia University 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 3 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 6 May 2026. 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 combined 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.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ronald A Lehman, MD (2129325067, rl2781@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal drop in systemic hemoglobin concentration during the postoperative period (time frame: Patients will be followed through postoperative day 4). 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 NCT02314988.

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 6 May 2026.

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