TXA Study in Major Oncologic Surgery

Not Applicable

Completed

• Conditions: Tranexamic Acid; Major Surgery; Cancer
• Interventions: Drug: Tranexamic Acid; Other: Placebo

• Registration Number: NCT01980355
• Lead Sponsor: Spectrum Health Hospitals

Brief Summary

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.

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 Timeline

• Study Start: 2012-06-12
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-08
• Primary Completion: 2017-12-01
• Study Completion: 2020-07-29
• Results First Submitted: 2021-09-25
• Results First Submitted QC: 2022-05-03
• Results First Posted: 2022-05-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	Tranexamic Acid	1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery.
Placebo	Placebo	Placebo given over 15 minutes into the vein once prior to surgery.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Required Transfusion	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 Outcome Measures

Name	Time	Method
Estimated Blood Loss	From time of surgery to 90 days post hospital discharge	Surgical blood loss estimation

Trial Locations

Locations (1)

Spectrum Health Hospitals; 🇺🇸 Grand Rapids, Michigan, United States