Tranexamic Acid for Reducing Blood Loss During Surgery for Pelvic Mass
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how well tranexamic acid reduces blood loss in patients with pelvic tumors undergoing hemipelvectomy surgery. Tranexamic acid stabilizes blood clots during surgery. The trial includes two groups: one receives tranexamic acid during surgery, while the other undergoes standard surgery without it. Patients with a pelvic tumor scheduled for surgery at the University of Texas MD Anderson Cancer Center may qualify for this trial. As an Early Phase 1 trial, this research aims to understand how tranexamic acid works in people, offering participants the chance to contribute to groundbreaking medical knowledge.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that tranexamic acid is likely to be safe for humans?
Research has shown that tranexamic acid is generally safe for use during surgeries. Studies have found it can reduce blood loss without increasing the risk of complications. For example, research on patients with pelvic fractures showed that tranexamic acid reduced the need for blood transfusions, indicating it is well-tolerated. Another study confirmed that administering tranexamic acid through an IV can decrease blood loss and the need for transfusions without adding extra risks during surgery. These findings suggest that tranexamic acid is a safe option for reducing blood loss in surgical settings.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about using tranexamic acid during surgery for pelvic mass removal because it offers a promising way to reduce blood loss. Unlike standard surgical practices that don't incorporate this medication, tranexamic acid works by preventing blood clots from breaking down too quickly, which can help minimize bleeding. Administered intravenously just before and during surgery, this approach could improve surgical outcomes and potentially lead to faster recovery times.
What evidence suggests that tranexamic acid is effective for reducing blood loss during hemipelvectomy surgery?
Research has shown that tranexamic acid reduces blood loss during surgeries. It proves effective in procedures like pelvic fractures and abdominal hysterectomies by helping blood clots remain intact. In patients with pelvic or hip socket fractures, tranexamic acid led to fewer blood transfusions. The CRASH-2 trial found that tranexamic acid lowered the risk of death from bleeding. In this trial, one group of participants will receive tranexamic acid to evaluate its effectiveness in reducing blood loss during complex surgeries like hemipelvectomy. These findings suggest that tranexamic acid could be useful in this context.12467
Who Is on the Research Team?
Valerae O. Lewis
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for both children and adults with pelvic tumors who are scheduled for hemipelvectomy surgery at UT MD Anderson Cancer Center. It's not for those with clotting disorders, thromboembolic disease, pregnant or nursing women, color vision defects, severe kidney issues, seizure disorders, recent intracranial hemorrhage, or allergy to tranexamic acid.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive tranexamic acid intravenously over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure
Postoperative Monitoring
Patients are monitored for blood loss, transfusion requirements, and complications during the first postoperative week
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Hemipelvectomy
- Tranexamic Acid
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator