80 Participants Needed

Tranexamic Acid for Reducing Blood Loss During Surgery for Pelvic Mass

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Overseen ByValerae O. Lewis, MD
Age: Any Age
Sex: Any
Trial Phase: Phase < 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

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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

I have a pelvic tumor and am scheduled for surgery at UT MD Anderson that involves removing part of my pelvis.
I am either under 18 or an adult.

Exclusion Criteria

My kidney function is normal or only slightly reduced.
You have had an allergic reaction to tranexamic acid in the past.
Patients will not be eligible if they have a history of color vision defects
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive tranexamic acid intravenously over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure

1 day
1 visit (in-person)

Postoperative Monitoring

Patients are monitored for blood loss, transfusion requirements, and complications during the first postoperative week

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Hemipelvectomy
  • Tranexamic Acid
Trial Overview The study is testing if tranexamic acid can reduce blood loss in patients undergoing hemipelvectomy surgery due to pelvic tumors. Tranexamic acid works by stabilizing clots and preventing them from breaking down during surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm II (no tranexamic acid)Experimental Treatment1 Intervention
Group II: Arm I (tranexamic acid)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Tranexamic acid (TXA) effectively reduces blood loss and the need for transfusions in various orthopedic surgeries, with recent studies showing that combining local and systemic delivery methods can enhance its benefits, particularly after hip arthroplasty.
A single systemic dose of TXA did not improve outcomes in foot and ankle surgery, highlighting the importance of delivery method, as repeated topical doses showed significant improvements in blood loss and recovery in other surgical contexts.
Local tranexamic acid reduces surgical blood loss.Bolton, L.[2022]
Intra-operative administration of tranexamic acid (TXA) combined with pre-operative discontinuation of chemoprophylaxis led to a significant 20.7% reduction in the need for blood transfusions among 159 patients undergoing pelvic or acetabular fracture surgery.
This treatment approach also resulted in an average reduction of 36 minutes in surgical time without increasing the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE), indicating it is both safe and effective.
Tranexamic acid with a pre-operative suspension of anticoagulation decreases operative time and blood transfusion in the treatment of pelvic and acetabulum fractures.Cohen-Levy, WB., Rush, AJ., Goldstein, JP., et al.[2021]
In a study of 141 high-risk patients undergoing surgery for intertrochanteric hip fractures, the administration of tranexamic acid (TXA) did not increase the risk of mortality or thromboembolic complications such as deep venous thrombosis (DVT) or pulmonary embolism (PE) within 90 days post-surgery.
The results suggest that TXA is safe for use in high-risk patients undergoing nonelective hip fracture surgery, as no significant differences in complications or mortality were observed when compared to patients who did not receive TXA.
Tranexamic Acid Was Not Associated with Increased Complications in High-Risk Patients with Intertrochanteric Fracture.Porter, SB., Spaulding, AC., Duncan, CM., et al.[2022]

Citations

Tranexamic Acid in Reducing Blood Loss in Patients With ...This early phase I trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery.
Tranexamic Acid for Reducing Blood Loss During Surgery ...Research shows that tranexamic acid (TXA) is effective in reducing blood loss in surgeries involving pelvic fractures and abdominal hysterectomy, suggesting it ...
Tranexamic acid use in pelvic and/or acetabular fracture ...TXA use was associated with a significantly lower transfusion rate in patients who underwent pelvic and/or acetabular fracture surgery.
Reducing Blood Loss in Hemipelvectomy Surgery with the ...This early phase I trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery.
Tranexamic acid: a narrative review of its current role in ...An exploratory analysis of the CRASH-2 trial found that TXA was associated with a decreased risk of death due to bleeding when administered ...
Efficacy and safety of intravenous tranexamic acid in...Intravenous TXA can reduce intraoperative blood loss, decrease the need for transfusion, and shorten operative time, and it does not increase the risk of ...
Does Intravenous Tranexamic Acid Reduce Blood Loss at ...This study showed no statistically significant differences in blood loss outcomes with the use of IV TXA at the time of total colpocleisis (±midurethral sling).
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