Tranexamic Acid Infusion During Elective Spine Surgery

Tranexamic acid (TXA) is an agent that has been shown to be safe and effective to reduce blood loss in surgical procedures. The purpose of the study is to assess the effect of transexamic on elective decompressive lumbar spine surgery with and without fusion.

Study Overview

• Status: Unknown
• Conditions: Spine Surgery
• Intervention / Treatment: Drug: Tranexamic Acid

Detailed Description

This will be a prospective randomized control, double-blinded investigation. The Investigators will recruit patients undergoing elective, primary, decompressive lumbar surgery via a posterior surgical approach of less than 3 levels. This includes patients undergoing decompressive lumbar laminectomies with or without fusion. Fusion may include posterior interbody and/or posterior lateral techniques with instrumentation.

There will be 3 treatment arms with the goal of 65 patients in each arm. Patients will be randomized pre-operatively and enrolled into the IV transexamic acid group (receiving intraoperative intravenous tranexamic acid infusion), or the topical transexamic acid group or the control/placebo group (receiving intraoperative intravenous saline). The Investigators expect the duration of each treatment group to be approximately 4-5 months. Therefore, the study should be completed within 1.5 years. The primary surgeon and anesthesia staff will not be blinded to the treatment arm due to the nature of the different administration routes, but post-operative nursing staff will be blinded to administration routes.

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing decompressive lumbar laminectomy with or without fusion
• Primary surgical procedure
• Competent adult able to give informed consent
• Age >18

Exclusion Criteria:

• h/o DVT or PE
• h/o seizure
• h/o coagulopathy
• Diagnosis of malignancy or infection as indication for surgical decompression
• Abnormal pre-operative PT/INR, aPTT, bleeding time
• Platelet count < 100
• Patients requiring therapeutic heparin or lovenox bridges prior to and/or after surgery
• Allergy to TXA
• Pregnant women and prisoners
• Renal insufficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patient will receive no transexemic acid of any kind
Experimental: IV-transexemic acid; weight adjusted standard dose of TXA will be administered to these subset of patients prior to incision in IV-form	Drug: Tranexamic Acid; IV and topical form of TXA will be administered to patients in the respective groups.
Experimental: Topical-transexemic acid; the wound site after the surgery is completed will be bathed in TXA for a standardized period of time prior to skin closure	Drug: Tranexamic Acid; IV and topical form of TXA will be administered to patients in the respective groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drain output	Drains will be placed during surgery, this will be recorded by nursing staff on a regular schedule and we will assess the results as a surrogate for blood loss post operatively	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hematocrit	Labs will be recorded each morning after the surgery, this includes hematocrit	two days post operatively
Change in hemoglobin	Labs will be recorded each morning after the surgery, this includes hemoglobin	two days post operatively
Emergency department visits	We will assess which treatment arms, if any had increased rate of Emergency department visits for any reason	30 days post operatively
number of hospital readmissions	We will assess which treatment arms, if any had increased rate of readmission to the hospital	30 days post operatively
Incidence of PE	We will assess is any treatment arm had an increased risk of PE	30 days post opertively
Incidence of DVT	We will assess is any treatment arm had an increased risk of DVT	30 days post opertively

Collaborators and Investigators

• Sponsor: Albany Medical College
• Investigators: Principal Investigator: James Lawrence, MD, Attending Surgeon

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 5176 (NTR)

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
• product manufactured in and exported from the U.S.: No