Combined IV and Topical TXA in Major Spine Surgery

The Effect of Combined Intravenous and Topical TXA in Major Multilevel Spine Surgery: A Prospective Randomized Trial

This is a randomized study. The purpose of this study is to evaluate the effect of tranexamic acid in patients undergoing multilevel spine surgery. 75 patients undergoing multi-level spine surgery will be enrolled at Mount Sinai West. Study participation will last from the time of pre-operative evaluation to the time of discharge from hospital. Specifically, the study team will compare tranexamic acid given only intravenously vs. given both topically and intravenously vs. given only intravenously but at a higher dosage. The study team hypothesizes that patient who received combined topical and intravenous TXA (low dose) have similar or decreased overall blood loss postoperatively compared to patient who received high or low dose intravenous TXA alone.

Study Overview

• Status: Recruiting
• Conditions: Back Pain; Spine Surgery
• Intervention / Treatment: Drug: High Dose Tranexamic acid; Drug: Normal saline; Drug: Low Dose Tranexamic acid; Drug: Tranexamic acid Topical

Detailed Description

Prospective triple-blinded randomized control trial. The surgeon will provide study information (protocol, consent, general information) to patients in the surgeon's office. Recruitment will be done through a coordination of the operating schedule and the surgeon's office. Patients presenting for preoperative visits at the surgeon's office or the preoperative joint clinic will be approached. On the day of the surgery, the subject will meet the research team in the holding area. The team will finalize participation and ask the subject about the signed consent forms and answer any additional questions. All patients will be provided with copies of the IRB protocol and consent if they wish to have it. Copy of the consent form will be sent in a secured email to the potential subject. The email will be secured by entering in [SECURE] in the e-mail subject line. Once recruited blinding assessments will be done by the study team.

Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1) High Dose Intravenous TXA (hTXA group), 2) Low Dose Intravenous TXA (lTXA group), or 3) Combined Intravenous and Topical TXA group (cTXA group). Surgical team will perform the required spine procedure. Study personnel will make the medication which will be labelled as study drug for surgical and anesthesia team to give during the procedure. Patients assigned to hTXA group will receive 50mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. Patients assigned to lTXA group will receive 20mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. Patients assigned to cTXA group will received 20mg/kg V TXA loading dose with a 5mg/kg/hr maintenance dose, and 2g topical TXA poured over 5 minutes at the would prior to closure. Otherwise, the patient, surgeon, and anesthesiologist in the case will be blinded.

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Poonam Pai, M.D.; Phone Number: 347-569-4816; Email: Poonam.PaiBantwalHebbalasankatte@mountsinai.org
• Study Contact Backup: Name: Daniel Amor, MD; Phone Number: (973) 897-8540; Email: daniel.amor@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Recruiting
      • Mount Sinai West Hospital
      • Contact: Shenghao Fang, M.D.; Phone Number: 434-326-8499; Email: shenghao.fang@mountsinai.org
      • Contact: Poonam Pai, M.D.; Phone Number: 347-569-4816; Email: Poonam.PaiBantwalHebbalasankatte@mountsinai.org
      • Principal Investigator: Yan Lai, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults 18-80 years old
• Undergo major multilevel spine surgery (2-8 levels)
• Male or female

Exclusion Criteria:

• ASA class V
• Urgent or emergent surgery,
• Morbid obesity
• Patients with known coagulopathy disorder, hx of thromboembolic event <1 year, renal insufficiency, hepatic dysfunction, serious cardiac disease
• Patients with known allergy to TXA or receiving antiplatelet and/or anticoagulant drugs
• Religious or other belief that limit blood transfusion,
• Surgery duration more than 6 hours
• Patient refusal or inability to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Dose Intravenous TXA (hTXA group); Patients assigned to hTXA group will receive 50mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure.	Drug: High Dose Tranexamic acid; 50mg/kg IV TXA; Other Names: hTXA; Drug: Normal saline; Normal saline poured on wound; Other Names: NS
Experimental: Low Dose Intravenous TXA (lTXA group); Patients assigned to lTXA group will receive 20mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure.	Drug: Normal saline; Normal saline poured on wound; Other Names: NS; Drug: Low Dose Tranexamic acid; 20mg/kg IV TXA; Other Names: lTXA
Placebo Comparator: Combined Intravenous and Topical TXA group (cTXA group); Patients assigned to cTXA group will received 20mg/kg V TXA loading dose with a 5mg/kg/hr maintenance dose, and 2g topical TXA poured over 5 minutes at the would prior to closure	Drug: Low Dose Tranexamic acid; 20mg/kg IV TXA; Other Names: lTXA; Drug: Tranexamic acid Topical; 2g topical TXA; Other Names: TXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hematocrit level	The amount of post-operative blood loss during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery. Specifically, the hematocrit number difference between baseline and post-operative day 1, 2 and 3.	Baseline and Post-operative day 1, 2 and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative drain output	The amount of post-operative drain output (ml) during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery.	Post-operative day 1, 2 and 3

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Yan Lai, M.D., Mount Sinai West and Morningside Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: tranexamic acid; Spine surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: GCO 19-1137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No