Tranexamic Acid to Reduce Blood Loss in Spine Surgery

NCT ID: NCT02314988

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2026-07-31

Brief 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.

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.

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.

Conditions

Spinal Injuries; Spinal Deformity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention

Subjects will receive tranexamic acid on the surgical wound.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

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.

Placebo control

Subjects will receive placebo (saline solution) on the surgical wound.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Tranexamic Acid

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

Cyclokapron; TXA; Saline Solution

Eligibility Criteria

Inclusion Criteria

1. Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation

2. Surgical fixation to be performed within 21 days of injury

3. Adult patients undergoing long segment (>5 fusion levels) posterior spinal fusions

Exclusion Criteria

1. Age <18 or >80 years old

2. Severe soft tissue disruption around planned surgical site preventing adequate primary wound closure

3. Physiologic instability or ongoing sepsis/infection

4. Use of intravenous tranexamic acid during the pre-study period

5. Ballistic spinal column injury

6. Allergy to tranexamic acid

7. Disturbances of color vision or color blindness

8. 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

9. Refusal to consent for blood products

10. Participation in another clinical trial

11. Moderate or severe traumatic brain injuries that do not allow participation in individual patient outcomes surveys

12. Subarachnoid hemorrhage, anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by TXA

13. Concomitant use of Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased

14. 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

15. Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment

16. Disseminated intravascular coagulation (DIC)

17. 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)

18. 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

19. Upper urinary tract or ureteral injury (ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported)

20. Pregnancy or breastfeeding (Category B)

21. Substantial renal dysfunction (as assessed by a serum creatinine > 1.5 or calculated creatinine clearance of < 50) or hepatic failure

22. 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.

23. History of seizure or convulsive disorders, or currently concomitant use of other medications that are known to reduce seizure threshold

24. History of dural tear or open subdural space

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Ronald A. Lehman

Professor of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald A Lehman, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

University of California San Francisco Medical Center

San Francisco, California, United States

Site Status: RECRUITING

Norton Leatherman Spine Center

Louisville, Kentucky, United States

Site Status: RECRUITING

NYP/The Allen Hospital - CUIMC

New York, New York, United States

Site Status: RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ronald A Lehman, MD

Role: CONTACT

rl2781@cumc.columbia.edu

2129325067

Matthew J. Cooney

Role: CONTACT

mc5386@cumc.columbia.edu

Facility Contacts

Ronald A. Lehman, MD

Role: primary

rl2781@cumc.columbia.edu

Other Identifiers

201409111

Identifier Type: OTHER

Identifier Source: secondary_id

AAAQ6795

Identifier Type: -

Identifier Source: org_study_id