Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery

June 6, 2017 updated by: Kirkham Wood, Massachusetts General Hospital

Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery

Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion. In addition it will also significantly reduce the cost of the surgical procedure.

Specific Aim 1: The goal of this study is to quantitatively assess whether topical application of tranexamic acid placed into the surgical wound during lumbar spine surgery will decrease post-operative blood loss, thus lowering the need for blood transfusions. By reducing the number of transfusions participants can avoid the well-known complications associated with them. The investigators do not plan on measuring serum tranexamic acid levels.

Several meta-analyses and level I studies have shown that intravenous (IV) administration of tranexamic acid is effective in reducing postoperative blood loss and the need for transfusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tranexamic acid, an antifibrinolytic agent, has been studied at great length across a myriad of medical specialties to reduce blood lost during these surgeries. Topical tranexamic acid administration reduces postoperative blood loss and proved safe in multiple types of surgeries -e.g. cardiothoracic, oral and maxillofacial, eye, ear and throat.(References: Fawzy and others [et al], Wong et al, Zufferey et al, Wang et al, Ipema et al).

Intravenous tranexamic acid administration has been shown to reduce postoperative blood loss and transfusion need in patients undergoing spinal surgery (Reference: Elwatidy et al). Some advocates have suggested that topical (i.e. local) administration might be preferred over intravenous application. Topical administration of tranexamic acid has some potential advantages as it leads to lower systemic absorption, and offers less concern over the risk of thromboembolic complications (References: Wong et al, Raveendran et al).

While systemic (intravenous) use of tranexamic acid has been studied in spine surgery, there has been little studied to show its effectiveness at reducing blood loss when used topically.

This study proposes to determine if the topical application of tranexamic acid into the surgical wound of posterior multi-level lumbar spine surgery will decrease postoperative blood loss, thus decreasing the need for potential transfusions. Tranexamic acid has been well documented for its safety and efficacy, the investigators believe that this agent will become an important tool to reduce the blood loss in spinal surgeries. It offers a reduction in blood loss and, ultimately, a decrease in the transfusion rates which pose risks to the subject and significant cost.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Orthopedic Spine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-85 years, both male and female
  • Undergoing elective multi-level spinal surgery with a posterior approach to the thoracolumbar spine.
  • Negative pregnancy test

Exclusion Criteria:

  • Allergy to tranexamic acid
  • Preoperative anemia (Hemoglobin <11 grams per deciliter [g/dL] )
  • Coagulopathy (preoperative platelet count <150,000, International Normalized Ratio >1.4, or Partial Thromboplastin Time > 1.5 times normal)
  • History of deep vein thrombosis, stroke, or pulmonary embolism
  • Pregnant or breast feeding
  • Liver function tests 2 times the upper limit of normal, and those with creatine greater than 1.6 milligrams per deciliter (mg/dL)
  • Infection
  • Revision procedure in which the only procedure is removing instrumentation
  • Renal impairment
  • Dural tear

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic acid
Participants undergoing spinal surgery will receive a single, topical dose of tranexamic acid. The surgeon will irrigate the study medication in the wound prior to closure, and aspirate it after five minutes. Drains will be placed after the study drug has been aspirated.
Drug: Tranexamic Acid
A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.
Other Names:
  • Cyklokapron®
Placebo Comparator: Placebo
Participants undergoing spinal surgery will receive a single, topical dose of matching placebo. The surgeon will irrigate the study medication in the wound prior to closure, and aspirate it after five minutes. Drains will be placed after the study drug has been aspirated.
Drug: Placebo
A single topical application of matching placebo, which is 100 mL of normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge
Time Frame: From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery
Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level.
From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Loss Volume Following Surgery
Time Frame: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days
Blood loss following surgery was defined as the total amount of fluid collected from the drain in the wound site during the hospital stay.
From end of surgery on Day 1 to end of hospital stay up to approximately 5 days
Hospital Length of Stay in Days
Time Frame: From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks
The number of days the participants stayed in the hospital after surgery was recorded.
From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks
Post-operative Blood Transfusions During Hospitalization
Time Frame: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days
All units of blood transfused during the hospital stay after surgery were recorded. One red blood cell unit contains 300 to 360 mL of whole blood.
From end of surgery on Day 1 to end of hospital stay up to approximately 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Kirkham B Wood, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

April 22, 2015

Study Completion (Actual)

April 22, 2015

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

February 13, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P000266 (Other Identifier: Massachusetts General Hospital IRB approved)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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