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Tranexamic Acid to Reduce Blood Loss in Spine Trauma Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02314988
Recruitment Status : Not yet recruiting
First Posted : December 11, 2014
Last Update Posted : March 28, 2019
Information provided by (Responsible Party):
Ronald A. Lehman, Columbia University

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 following high energy trauma who have sustained thoracic or lumbar spine fractures, dislocations or ligamentous injury with resultant instability 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 2 week, 16 week, 1 year, and 2 year) time points.

Condition or disease Intervention/treatment Phase
Spinal Injuries Spinal Deformity Drug: Tranexamic Acid Drug: Placebo Phase 2 Phase 3

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 trauma surgery reduces blood loss, and subsequently reduces the rate of allogenic blood transfusion and surgical site infection.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Topical Application of Tranexamic Acid to Reduce Blood Loss During Complex Combat-related Spine Trauma Surgery
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Intervention
Subjects will receive tranexamic acid on the surgical wound.
Drug: 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.

Other Names:
  • Cyclokapron
  • TXA

Placebo Comparator: Placebo control
Subjects will receive placebo (saline solution) on the surgical wound.
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.

Other Name: Saline Solution

Primary Outcome Measures :
  1. Maximal drop in systemic hemoglobin concentration during the postoperative period [ Time Frame: Patients will be followed through postoperative day 4 ]

Secondary Outcome Measures :
  1. Reduction in the rate of surgical site infections [ Time Frame: Duration of the hospital stay (an average of 2 weeks), first postoperative wound check visit ]
    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).

  2. Number of complications [ Time Frame: Up to postoperative day 4 ]
    Defined as thromboembolic event, including deep vein thrombosis (DVT) or pulmonary embolism (PE)

  3. Systemic absorption of locally applied drug [ Time Frame: Baseline (pre-surgery), immediately after administration of the topical agent, 1 hour after administration ]
  4. Patient assessed health-related quality of life score [ Time Frame: Up to 2 years postoperation ]
    This will be determined by a questionnaire/score

  5. Difference in costs for hospital stay between using tranexamic acid and placebo [ Time Frame: Duration of the hospital stay (an average of 2 weeks) ]
    Patient cost information will be gathered for the duration of the hospital stay

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 >75 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. Previous thoracic or lumbar spine surgery
  12. Moderate or severe traumatic brain injuries that do not allow participation in individual patient outcomes surveys
  13. Subarachnoid hemorrhage, anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by TXA
  14. Concomitant use of Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased
  15. 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
  16. Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment
  17. Disseminated intravascular coagulation (DIC)
  18. 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)
  19. 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
  20. Upper urinary tract or ureteral injury (ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported)
  21. Pregnancy or breastfeeding (Category B)
  22. Substantial renal dysfunction (as assessed by a serum creatinine > 1.5 or calculated creatinine clearance of < 50) or hepatic failure
  23. 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.
  24. History of seizure or convulsive disorders, or currently concomitant use of other medications that are known to reduce seizure threshold
  25. History of dural tear or open subdural space

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02314988

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Contact: Ronald A Lehman, MD 2129325067

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United States, Maryland
Walter Reed National Medical Center
Bethesda, Maryland, United States, 20889
United States, New York
NYP/The Allen Hospital - CUMC
New York, New York, United States, 10032
Contact: Ronald A Lehman, MD   
Principal Investigator: Ronald A Lehman, MD         
United States, Pennsylvania
Thomas Jefferson University Medical Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Columbia University
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Principal Investigator: Ronald A Lehman, MD Columbia University
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Responsible Party: Ronald A. Lehman, Professor of Orthopaedic Surgery, Columbia University Identifier: NCT02314988    
Other Study ID Numbers: AAAQ6795
201409111 ( Other Identifier: Washington University )
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ronald A. Lehman, Columbia University:
Tranexamic acid
Perioperative blood loss
Postoperative drain output
Allogenic transfusion
Additional relevant MeSH terms:
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Spinal Injuries
Pathologic Processes
Back Injuries
Wounds and Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action