TXA Study in Major Oncologic Surgery (TXA)

August 3, 2023 updated by: Gerald P. Wright, Spectrum Health Hospitals

The Effect of Tranexamic Acid on Blood Loss and Transfusion Rates in Major Oncologic Surgery

Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a treatment for heavy menstrual bleeding. Over the past 20 years it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. We believe tranexamic acid may possibly decrease bleeding related to major surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your surgical hospital stay.

In this study, you will receive either the drug tranexamic acid or a placebo. The placebo looks like the tranexamic acid, but does not have any active ingredient in it. The treatment you get will be chosen by chance, like flipping a coin. You will have equal chance of being given the tranexamic acid or the placebo. In this study, both the tranexamic acid and the placebo are considered research.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given the tranexamic acid or the placebo. Neither you nor the study doctor will know which treatment you are getting.

You will receive one 1000 mg dose of either tranexamic acid or placebo immediately before surgery. This dose of tranexamic acid or placebo will be given in your vein over 15 minutes.

Information from your medical record related to your surgery and recovery time in the hospital will be collected by medical staff assisting with this study and recorded on study forms. These study forms will be labeled with your study number instead of your name. Additionally, if you return to the hospital within 90 days after you went home from the hospital, information about that hospital visit(s) will also be collected from your medical record.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

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
    • Michigan
      • Grand Rapids, Michigan, United States, 49506
        • Spectrum Health Hospitals

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Subjects undergoing major oncologic surgery for standard of care purposes (to include, but not limited to: liver resections, radical cholecystectomy, pancreaticoduodenectomy (Whipple procedure), esophagectomy, gastrectomy, colectomy, debulking with hyperthermic intraperitoneal chemotherapy, prostatectomies, nephrectomies and partial nephrectomies)
  • Male or female > 18 years of age
  • Subject agrees to participate in this study and provides informed consent

Exclusion Criteria

  • Subjects with a history of hypercoagulopathy, deep vein thrombosis or pulmonary embolism
  • Subjects that are on therapeutic anticoagulation or therapeutic antiplatelet medications at the time of surgery other than Aspirin
  • Subjects with a history of TIA or stroke
  • Subjects with a history of atrial fibrillation
  • Subjects with a known thrombus
  • Baseline creatinine level greater than 2.83 mg/dL
  • Subjects with known hypersensitivity to tranexamic acid
  • Adults unable to provide informed consent
  • Children
  • Pregnant women
  • Prisoners
  • Non-English speaking subjects
  • Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic Acid
1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery.
Drug: Tranexamic Acid
Placebo Comparator: Placebo
Placebo given over 15 minutes into the vein once prior to surgery.
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Required Transfusion
Time Frame: From time of surgery to 90 days post hospital discharge
To determine the impact of perioperative administration of tranexamic acid on blood loss and transfusion rates in major oncologic surgery
From time of surgery to 90 days post hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Blood Loss
Time Frame: From time of surgery to 90 days post hospital discharge
Surgical blood loss estimation
From time of surgery to 90 days post hospital discharge

Collaborators and Investigators

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

Sponsor

Spectrum Health Hospitals

Investigators

  • Principal Investigator: Gerald P Wright, MD, Spectrum Health Hospitals

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)

June 12, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

July 29, 2020

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimated)

November 8, 2013

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-133

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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