Clinical Trial: Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)

Brief Summary: The goal of this clinical research study is to determine if tranexamic acid can help in reduction of blood and blood product loss before, during, and after surgery.

Detailed Summary:

Study Groups:

If participant agrees to take part in this study, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. Participant will have an equal chance of being assigned to either group.

During surgery, one group will receive the study drug by vein and the other group will not.

The study staff and surgeons will know if participant is receiving the study drug or not.

Surgery:

Participant will have participant's surgery as planned. Participant will sign a separate consent for the surgery that explains the procedure and the risks.

Medical Information Collection:

Researchers will collect information from participant's medical record before, during, and after the surgery for this study.

Blood Draws:

Blood (about 2-4 teaspoons each time) will be drawn for routine tests 1 time daily for the 7 days directly after surgery.

Length of Study Participation:

Participation on the study will be over after participant's routine blood draw 7 days after surgery.

This is an investigational study.

Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.


Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Total Perioperative Blood Loss [ Time Frame: During first postoperative week ]

Total perioperative blood loss defined as intraoperative estimated blood loss (EBL) plus drain output during 1st postoperative week.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: April 21, 2017
Date Started: May 19, 2017
Date Completion: May 2021
Last Updated: May 19, 2017
Last Verified: May 2017