Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT04312880

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Albany Medical Center

Albany, New York, 12208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

IV and topical form of TXA will be administered to patients in the respective groups.

Primary outcomes

  1. Drain output

    Time frame: 48 hours postoperatively

    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

Secondary outcomes

  1. Change in hematocrit

    Time frame: two days post operatively

    Labs will be recorded each morning after the surgery, this includes hematocrit

  2. Change in hemoglobin

    Time frame: two days post operatively

    Labs will be recorded each morning after the surgery, this includes hemoglobin

  3. Emergency department visits

    Time frame: 30 days post operatively

    We will assess which treatment arms, if any had increased rate of Emergency department visits for any reason

  4. number of hospital readmissions

    Time frame: 30 days post operatively

    We will assess which treatment arms, if any had increased rate of readmission to the hospital

  5. Incidence of PE

    Time frame: 30 days post opertively

    We will assess is any treatment arm had an increased risk of PE

  6. Incidence of DVT

    Time frame: 30 days post opertively

    We will assess is any treatment arm had an increased risk of DVT

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2020
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.