Tranexamic Acid for Reducing Blood Loss During Surgery for Pelvic Mass
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Thromboembolic disease, Pregnancy, Seizure, others
No Placebo Group
Trial Summary
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.
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?
Is tranexamic acid safe for use in surgery?
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.134910
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.
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Trial 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 (Surgery)
- Tranexamic Acid (Antifibrinolytic Agent)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: Arm II (no tranexamic acid)Experimental Treatment1 Intervention
Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (tranexamic acid)Experimental Treatment2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Tranexamic Acid Use in Open Reduction and Internal Fixation of Fractures of the Pelvis, Acetabulum, and Proximal Femur: A Randomized Controlled Trial. [2020]To assess the safety and efficacy of tranexamic acid (TXA) use in fractures of the pelvic ring, acetabulum, and proximal femur.
The effect of tranexamic acid in open reduction and internal fixation of pelvic and acetabular fracture: A systematic review and meta-analysis. [2023]Pelvic bone fractures may cause extensive bleeding; however, the efficacy of tranexamic acid (TXA) usage in pelvic fracture surgery remains unclear. In this systematic review and meta-analysis, we aimed to evaluate the efficacy of TXA in open reduction and internal fixation surgery for pelvic and acetabular fracture.
Topical versus intravenous tranexamic acid as a blood conservation intervention for reduction of post-operative bleeding in hemiarthroplasty. [2022]This study was performed to test the effectiveness of topical tranexamic acid (TXA) in reducing blood loss in pelvic hemiarthoplasty surgeries compared with intravenous TXA, regarding the incidence of thromboembolic complications (deep vein thrombosis [DVT], pulmonary embolism (PE) and cerebrovascular stroke [CVS]).
Topical vs. intravenous administration of tranexamic acid to minimize blood loss in abdominal hysterectomy perioperatively: A randomized controlled study. [2022]Topical application of tranexamic acid (TXA) to bleeding wound surfaces is rapidly gaining recognition and currently a topic of further research in patients undergoing abdominal hysterectomy. The aim of the study was to compare the efficacy of topical vs. intravenous (i.v.) administration of TXA in reducing perioperative blood loss in patients undergoing abdominal hysterectomy.
Tranexamic acid with a pre-operative suspension of anticoagulation decreases operative time and blood transfusion in the treatment of pelvic and acetabulum fractures. [2021]The purpose was to evaluate the impact of intra-operative administration of tranexamic acid (TXA) and pre-operative discontinuation of prophylactic chemoprophylaxis in patients undergoing internal fixation of pelvic or acetabular fractures on the need for subsequent blood transfusion. Operative time and the incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) were also assessed.
Tranexamic Acid Was Not Associated with Increased Complications in High-Risk Patients with Intertrochanteric Fracture. [2022]For elective total joint arthroplasty, tranexamic acid (TXA) is considered safe and efficacious. However, evidence of TXA's safety in high-risk patients undergoing nonelective surgery for hip fracture is sparse. This study aimed to assess whether TXA administration to high-risk patients with an intertrochanteric (IT) hip fracture increased the risk of thromboembolic complications or mortality.
Tranexamic acid in gynecologic surgery. [2020]Objective: To review the mechanism of action, pharmacology, dosing, and complications of tranexamic acid (TXA) and consolidate current evidence for TXA in gynecologic surgery.Methods: A literature search of PubMed, Ovid (MEDLINE), Google Scholar, and Elsevier was performed, in addition to a targeted search of cited references involving TXA and gynecologic surgery. Preference was given to systematic reviews and randomized control trials (RCTs).Results: TXA reversibly binds to plasminogen, preventing clot degradation. RCTs on hysterectomy, myomectomy, cervical conisation, hysteroscopy, and surgery for cervical and ovarian cancer were identified, as were case reports on TXA use for ectopic pregnancy. During hysterectomy, TXA reduces blood loss (two RCTs, n = 432, mean difference -66.0 mL and 180 mL), blood transfusion (1 RCT, n = 100, 12% vs. 42%, p < .00001). For myomectomy, a systematic review and meta-analysis showed a statistically significant decrease in blood loss with TXA (two RCTs, mean difference -213.1 mL, 95% CI: -242.4 mL to -183.7 mL). Following cervical conisation, TXA decreased the risk of delayed hemorrhage (four RCTs, RR 0.23, 95% CI: 0.11-0.50). A single RCT for cervical and ovarian cancer surgery demonstrated a decrease mean blood loss of 120 mL-135 mL and 210 mL, respectively, and fewer blood transfusions for the latter (OR 0.44, upper 95% CI: 0.97, p = .02). Less robust data suggest a possible benefit from TXA during hysteroscopy and surgery for ectopic pregnancies. Most commonly, 1 g of intravenous TXA is given intraoperatively.Conclusion: TXA is a safe adjunct that can be considered in a variety of gynecologic surgeries to decrease blood loss and risk of blood transfusion.
Tranexamic acid safely reduces hidden blood loss in patients undergoing intertrochanteric fracture surgery: a randomized controlled trial. [2022]To investigate the efficacy and safety of intravenous tranexamic acid (IV-TXA) in patients undergoing intertrochanteric fracture surgery.
Local tranexamic acid reduces surgical blood loss. [2022]Tranexamic acid (TXA) is a synthetic lysine analog that reduces perioperative blood loss by blocking lysine-binding sites on plasminogen molecules. It has been reported to be effective in limiting blood loss and transfusion needs in various orthopedic surgeries and for pediatric patients at high risk of blood loss. Randomized controlled trials (RCTs) supporting the capacity of TXA to reduce blood loss and improve outcomes associated with various surgical procedures have increased fourfold in the 10 years since Evidence Corner addressed this topic, which highlighted the capacity of locally delivered TXA to reduce blood loss during orthopedic knee surgery and intravenously delivered TXA to reduce blood lost during elective cesarean sections. Research continues to explore whether the ideal method of TXA delivery is local or systemic. One systemic preoperative 10 mg/kg dose of TXA did not improve blood loss, wound healing, or pain-related outcomes associated with ambulatory foot and ankle surgery. However, repeated topical doses of TXA as well as combined systemic and topical doses improved blood loss, inflammation, and nutritional condition following hip arthroplasty. This installment of Evidence Corner reviews 2 recent studies exploring the effects of adding locally delivered TXA to intravenous (IV) systemic TXA during spinal surgery8 and confirming efficacy of a single dose of topical TXA on hip arthroplasty.
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]Major bleeding and receiving blood products in cancer surgery are associated with increased postoperative complications and worse outcomes. Tranexamic acid (TXA) reduces blood loss and improves outcomes in various surgical specialities. We performed a systematic review and meta-analysis to investigate TXA use on blood loss in elective abdominal and pelvic cancer surgery.