Tranexamic Acid for Reducing Blood Loss During Surgery for Pelvic Mass

Overseen By Valerae O. Lewis, MD

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Thromboembolic disease, Pregnancy, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

80 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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

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

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?

Group I: Arm II (no tranexamic acid) Experimental Treatment 1 Intervention

Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (tranexamic acid) Experimental Treatment 2 Interventions

Patients receive tranexamic acid IV over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic Acid Was Not Associated with Increased Complications in High-Risk Patients with Intertrochanteric Fracture. Porter, SB., Spaulding, AC., Duncan, CM., et al.[2022]

Tranexamic acid (TXA) effectively reduces blood loss and the need for blood transfusions in various gynecologic surgeries, including hysterectomy and myomectomy, based on randomized control trials involving hundreds of patients.

TXA works by binding to plasminogen, preventing the breakdown of blood clots, making it a safe and beneficial adjunct in surgical procedures to manage bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid in gynecologic surgery. Zakhari, A., Sanders, AP., Solnik, MJ.[2020]

In a systematic review of 12 studies involving 1,382 patients undergoing elective abdominal and pelvic cancer surgery, the use of tranexamic acid (TXA) significantly reduced blood loss and the need for red blood cell transfusions, indicating its efficacy in managing surgical bleeding.

TXA did not increase the risk of venous thromboembolism (VTE), suggesting it is a safe option for patients undergoing cancer surgery, although more research is needed in specific surgical sub-specialties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact on blood loss and transfusion rates following administration of tranexamic acid in major oncological abdominal and pelvic surgery: A systematic review and meta-analysis. Fowler, H., Law, J., Tham, SM., et al.[2022]

Topical application of tranexamic acid (TXA) is as effective as intravenous administration in reducing total perioperative blood loss during abdominal hysterectomy, with no significant difference in blood loss between the two methods (312 ml vs. 325 ml).

Both methods of TXA administration resulted in similar reductions in hemoglobin levels postoperatively, indicating that topical TXA can be a viable alternative to intravenous TXA for managing blood loss in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical vs. intravenous administration of tranexamic acid to minimize blood loss in abdominal hysterectomy perioperatively: A randomized controlled study. Mitra, S., Jain, K., Singh, J., et al.[2022]

In a systematic review of 6 studies involving 764 patients, tranexamic acid (TXA) did not significantly reduce estimated blood loss (EBL) during pelvic and acetabular fracture surgery compared to a control group.

The use of TXA also showed no significant differences in transfusion rates, venous thromboembolism incidence, or postoperative infection rates, suggesting that TXA may not provide additional benefits in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of tranexamic acid in open reduction and internal fixation of pelvic and acetabular fracture: A systematic review and meta-analysis. Kim, CH., Hwang, J., Lee, SJ., et al.[2023]

In a study of 122 patients undergoing intertrochanteric fracture surgery, intravenous tranexamic acid (IV-TXA) significantly reduced hidden blood loss (HBL) compared to a placebo, with mean HBL of 640.96 ml in the TXA group versus 1010.11 ml in the placebo group (P < 0.001).

IV-TXA also decreased the need for blood transfusions, with a transfusion rate of 29.5% in the TXA group compared to 60.7% in the placebo group (P = 0.001), while showing no increased risk of thromboembolic events, such as deep venous thrombosis, within 90 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid safely reduces hidden blood loss in patients undergoing intertrochanteric fracture surgery: a randomized controlled trial. Zhang, S., Xiao, C., Yu, W., et al.[2022]

Topical tranexamic acid (TXA) significantly reduced post-operative blood loss in pelvic hemiarthroplasty surgeries compared to a placebo, showing its efficacy as a treatment option.

However, intravenous TXA was associated with a higher incidence of thromboembolic complications, such as deep vein thrombosis and pulmonary embolism, suggesting that while topical TXA is effective, it may have a safer profile regarding these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical versus intravenous tranexamic acid as a blood conservation intervention for reduction of post-operative bleeding in hemiarthroplasty. Emara, WM., Moez, KK., Elkhouly, AH.[2022]

In a study involving 93 patients with high-energy fractures, the use of tranexamic acid (TXA) significantly reduced total blood loss (TBL) compared to the control group, with TBL of 952 mL for TXA versus 1325 mL for no TXA (P = 0.028).

Despite the reduction in blood loss, TXA did not significantly lower overall transfusion rates or increase the risk of venous thromboembolic events (VTE), indicating it is safe to use in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic Acid Use in Open Reduction and Internal Fixation of Fractures of the Pelvis, Acetabulum, and Proximal Femur: A Randomized Controlled Trial. Spitler, CA., Row, ER., Gardner, WE., et al.[2020]

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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.

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