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

Trial Summary

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.

What data supports the effectiveness of the drug tranexamic acid (TXA) in reducing blood loss during surgery for pelvic mass?

Research shows that tranexamic acid (TXA) is effective in reducing blood loss in surgeries involving pelvic fractures and abdominal hysterectomy, suggesting it may also help reduce bleeding in surgeries for pelvic masses. ^{1 2 3 4 5}

Is tranexamic acid safe for use in surgery?

Tranexamic acid (TXA) is generally considered safe for use in various surgeries, including gynecologic and fracture surgeries, as it helps reduce blood loss without increasing the risk of complications. ^{1 2 6 7 8}

How does the drug tranexamic acid differ from other treatments for reducing blood loss during surgery for pelvic mass?

Tranexamic acid (TXA) is unique because it can be administered both topically and intravenously to reduce blood loss during surgery by blocking the breakdown of blood clots. This dual administration method is being explored for its effectiveness in various surgeries, including those involving the pelvis, and may offer advantages over traditional methods that do not utilize TXA. ^{1 3 4 9 10}

What is the purpose of this trial?

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 decreases blood loss by stabilizing clots and preventing clot lysis in patients undergoing surgery.

Research Team

Valerae O. Lewis

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

You have had an allergic reaction to tranexamic acid in the past.

My kidney function is normal or only slightly reduced.

I have a genetic condition that increases my risk of blood clots.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States 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. [2020]

2. United States 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. [2023]

3. India pubmed.ncbi.nlm.nih.gov

Topical versus intravenous tranexamic acid as a blood conservation intervention for reduction of post-operative bleeding in hemiarthroplasty. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Topical vs. intravenous administration of tranexamic acid to minimize blood loss in abdominal hysterectomy perioperatively: A randomized controlled study. [2022]

5. Germany 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Tranexamic Acid Was Not Associated with Increased Complications in High-Risk Patients with Intertrochanteric Fracture. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid in gynecologic surgery. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Tranexamic acid safely reduces hidden blood loss in patients undergoing intertrochanteric fracture surgery: a randomized controlled trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Local tranexamic acid reduces surgical blood loss. [2022]

10. United States 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. [2022]