Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tranexamic Acid in Adult Spinal Deformity 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.
 
ClinicalTrials.gov Identifier: NCT03553186
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical specialties. Intravenous TXA (ivTXA) is routinely used at our institution for adult spinal deformity cases. Meanwhile, topical TXA (tTXA) is an attractive alternative/adjunct to ivTXA used with good results in orthopedic arthroplasty and cardiac surgery. To the investigators' knowledge, no data exists in the literature on the use of tTXA in either adult or pediatric spinal deformity surgery. The goal of this study is to determine the role tTXA has an adjunct to ivTXA in decreasing perioperative blood loss, drainage, transfusion requirements and length of stay following adult deformity spine surgery.

Condition or disease Intervention/treatment Phase
Spinal Deformity Degenerative Lumbar Spinal Stenosis Blood Loss, Surgical Drug: Tranexamic Acid 100 MG/ML Drug: Placebo Phase 3

Detailed Description:
Blood loss is a significant issue in spinal deformity surgery, often requiring allogenic blood transfusion and/or intraoperative blood salvage and leading to increased risk of postoperative morbidity, increased length of stay, and higher total hospital costs. Tranexamic acid is an antifibrinolytic agent that is used in many surgical specialties to prevent perioperative blood loss. Intravenous (ivTXA) dosing has proven effective in reducing blood loss and perioperative transfusion in spinal surgery, while the topical (tTXA) form has been shown to be at least non-inferior to IV transfusion in the total arthroplasty literature. Intravenous TXA is routinely used at the investigators' institution in spinal deformity cases, but even with ivTXA infusion, perioperative blood loss remains a significant issue, with total estimated and calculated blood loss between ~1500-3000 mL. Usage of local tTXA in addition to ivTXA may provide additional benefits including an additive effect on decreasing blood loss, allowing for lowered dosages of ivTXA, decreasing risks associated with systemic exposure. Combination ivTXA and tTXA has shown excellent results in total joint arthroplasty. The objective of this study is to determine the additive benefit and risks of co-administration of the two in spinal deformity surgery. This population of spinal patients was chosen because the estimated blood loss is high and the potential clinical benefit of the intervention is large. Patients will be enrolled if they are undergoing surgery > 5 levels with extension to the pelvis. The investigators have previously utilized topical TXA for these cases by applying operative sponges soaked with solution into the wound during routine x-ray check following instrumentation, with anecdotally good effect. However, this practice has not been prospectively studied. In this prospective, randomized, blinded, placebo controlled study, a similar combined effect of ivTXA and tTXA on decreasing perioperative blood loss as seen in total joint arthroplasty, with a similar safety profile is expected.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Simple blinded randomization will occur by the pharmacy prior to distribution of the intervention drug.
Primary Purpose: Treatment
Official Title: Topical Tranexamic Acid as a Adjunct to Intravenous Tranexamic Acid in Adult Spinal Deformity Surgery
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ivTXA + topical TXA

TXA lavage solution (200 cc sterile normal saline + 5 g tranexamic acid 100mg/ml (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after instrumentation and prior to grafting. Excess solution will be suctioned away using a non-cell saver suction and the wound grafted and closed without further deep irrigation.

IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2 mg/kg/hr maintenance dosing as per hospital protocol

Drug: Tranexamic Acid 100 MG/ML
TXA lavage solution (200 cc sterile normal saline + 5 g tranexamic acid 100mg/ml (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after instrumentation and prior to grafting. Excess solution will be suctioned away using a non-cell saver suction and the wound grafted and closed without further deep irrigation.
Other Name: Intervention group

Placebo Comparator: IV TXA + topical placebo

Placebo solution (200 cc sterile normal saline + placebo TXA ampule (normal saline) (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after pedicle screw instrumentation and prior to grafting. Excess solution will be suctioned away using a non-cell saver suction and the wound grafted and closed without further deep irrigation.

IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2mg/kg/hr maintenance dosing as per hospital protocol

Drug: Placebo
Placebo solution (200 cc sterile normal saline + placebo TXA ampule (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after pedicle screw instrumentation and prior to grafting. Excess solution will be suctioned away using a non-cell saver suction and the wound grafted and closed without further deep irrigation.
Other Name: Control group




Primary Outcome Measures :
  1. Postoperative Drain output [ Time Frame: 48 hours ]
    Drain Output


Secondary Outcome Measures :
  1. Perioperative blood transfusion [ Time Frame: Up to 30 days postoperatively ]
    Number of units of blood transfused perioperatively, including cell saver administration

  2. Perioperative blood drop [ Time Frame: Up to 72 hours postoperatively ]
    CBC with hct/hg tracked postoperatively

  3. Perioperative adverse events [ Time Frame: Up to 30 days postoperatively ]
    Minor and major adverse events occuring during hospitalization or after discharge

  4. Length of stay [ Time Frame: Up to 30 days postoperatively ]
    # of days from surgery to discharge



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80
  • Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae
  • + fusion to pelvis

Exclusion Criteria:

  • Surgical factors:

    • Anterior Approach
    • Presence or history of dural tear without repair as evidenced by pseudomeningocele on MRI imaging or by intraoperative exploration
    • Patients donating autologous blood preoperatively

Patient factors:

  • Diagnosis of renal (Cr>1.5 or CrCl <30ml/min) or hepatic insufficiency (AST, ALT 2x upper limit of normal)
  • Diagnosis of seizure disorder or prior seizure
  • History of thromboembolic events (CVA, TIA, DVT, PE) if within 1 year of surgery
  • Hypercoagulability (e.g. antiphospholipid syndrome)
  • History of coronary artery disease (stent, MI, +stress test) within 1 year of surgery
  • Atrial fibrillation
  • Concurrent anticoagulation therapy that cannot be discontinued within 3 days before surgery (Coumadin, plavix, LVX)
  • Concurrent anticoagulation with ASA 325 that cannot be discontinued 10 days before surgery
  • Bleeding disorder or abnormal preoperative coagulation profile (as identified by a preoperative platelet count of <100,000/mm3, an international normalized ratio of >1.4, or a prolonged partial thromboplastin time >1.4 times normal)
  • Preexisting anemia <10 g/dL
  • Color blindness or disturbance of color vision
  • Leukemia or active cancer
  • Religious restrictions on blood transfusion
  • Pregnancy or women who are lactating/breastfeeding

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 ClinicalTrials.gov identifier (NCT number): NCT03553186


Contacts
Layout table for location contacts
Contact: Jordan A Gruskay, MD 2034647759 gruskayj@hss.edu
Contact: Evangelia Zgonia, BA 2127742837 zgonise@hss.edu

Locations
Layout table for location information
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Evangelia Zgonis         
Principal Investigator: Han Jo Kim, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Layout table for investigator information
Principal Investigator: Han Jo Kim, MD Department of Spine Surgery

Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03553186     History of Changes
Other Study ID Numbers: 2017-0920
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Stenosis
Congenital Abnormalities
Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Intraoperative Complications
Tranexamic Acid
Pharmaceutical Solutions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants