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Completed

NCT Number: NCT01980355

TXA Study 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.

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Key information

Conditions

Tranexamic Acid Cancer Major Surgery Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tranexamic Acid

Drug

Placebo

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Estimated Blood Loss

    Time frame: From time of surgery to 90 days post hospital discharge

    Surgical blood loss estimation

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Official study title

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

Acronym: TXA

Important dates

Study start
2012
Primary completion
2017
Study completion
2020
First posted
Nov 8, 2013
Registry last updated
Aug 7, 2023

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.

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