CLINICAL TRIAL

Tranexamic Acid for Bone Cancer

Recruiting · < 65 · All Sexes · Memphis, TN

Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure

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About the trial for Bone Cancer

Eligible Conditions
Limb Salvage · Bone Neoplasms · Cancer of the Bone

Treatment Groups

This trial involves 2 different treatments. Tranexamic Acid is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Tranexamic Acid
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
0.9% sodium chloride
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved

Side Effect Profile for Tranexamic Acid

Tranexamic Acid
Show all side effects
Myocardial infaction
8%
Postoperative wound infection
8%
Postoperative wound infection after release from hospital
8%
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02063035) in the Tranexamic Acid ARM group. Side effects include: Myocardial infaction with 8%, Postoperative wound infection with 8%, Postoperative wound infection after release from hospital with 8%.

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Someone who is having surgery to remove a tumor from their leg bone and who will need blood transfusions. show original
The patient is aged under 25. show original
of surgery This policy states that no RBC transfusions are to be given within 24 hours of surgery. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Pre-operatively (no more than 7 days prior to start of therapy), daily while inpatient and post operatively (approximately 1 week post-op)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Pre-operatively (no more than 7 days prior to start of therapy), daily while inpatient and post operatively (approximately 1 week post-op).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Tranexamic Acid will improve 2 primary outcomes and 5 secondary outcomes in patients with Bone Cancer. Measurement will happen over the course of Pre-operatively (no more than 7 days prior to start of therapy), daily while inpatient and post operatively (approximately 1 week post-op).

Changes in platelet level
PRE-OPERATIVELY (NO MORE THAN 7 DAYS PRIOR TO START OF THERAPY), DAILY WHILE INPATIENT AND POST OPERATIVELY (APPROXIMATELY 1 WEEK POST-OP)
Summary statistics will be provided for the changes in platelet level from pre-op to post-op level, for both the TXA and placebo group. Two sample t-test or Wilcoxon rank sum test will be used to compare the differences between the two groups. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.
Difference in intra-operatively transfused blood volume (mL/kg)
DURING SURGERY
The intra-operative volumes of transfused blood for both the TXA treated group and placebo group will be estimated with a two-sided 95% confidence interval. The blood volumes transfused per kilogram of body weight of the two groups (TXA vs. Placebo) will be evaluated using a two-sided student's t-test after log(1+x) transformation.
Post-operative daily surgical drain output
AFTER SURGERY FOR THE DURATION UNTIL THE DRAIN IS PULLED (APPROXIMATELY 1-7 DAYS)
Summary statistics will be provided for postoperative daily surgical drain output (in milliliters per 24 hour period for the duration of the drain) for each group. The group difference will be compared using two-sample t-test or Wilcoxon rank sum test depending on the distribution of the observed data. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.
Intra-or post-operatively transfused blood volume
DURING AND AFTER SURGERY (APPROXIMATELY 1 -7 DAYS)
Regression model will be used to access the correlation between the log transformed intra-or post-operatively transfused blood volume and EBL.
Difference in post-operatively transfused blood volume (mL/kg)
AFTER SURGERY; APPROXIMATELY 1-7 DAYS
The post-operative volumes of transfused blood for both the TXA treated group and placebo group will be estimated with a two-sided 95% confidence interval. The blood volumes transfused per kilogram of body weight of the two groups (TXA vs. Placebo) will be evaluated using a two-sided student's t-test after log(1+x) transformation.
Changes in hemoglobin level (g/dL)
PRE-OPERATIVELY (NO MORE THAN 7 DAYS PRIOR TO START OF THERAPY), DAILY WHILE INPATIENT AND POST OPERATIVELY (APPROXIMATELY 1 WEEK POST-OP)
Summary statistics will be provided for the decline in hemoglobin from pre-op to post-op level, for both the TXA and placebo group. Two sample t-test or Wilcoxon rank sum test will be used to compare the differences between the two groups. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can bone cancer be cured?

The prognosis is good in benign bone tumours, but the prognosis of malignant bone tumours is poor. Because of the poor prognosis after relapse, and the likelihood that cure will not be achieved, a cure for osteosarcoma cannot be recommended. However, bone tumours can be controlled to a great extent in children, where cure may be possible.

Anonymous Patient Answer

What is bone cancer?

Bone cancer is a rare disease, affecting people of all ages, races and genders. Bone cancer can produce pain, numbness, weakness, and other symptoms. X-rays, CT scans, MRIs, and bone scintigraphies are often the way for diagnosis.

Anonymous Patient Answer

How many people get bone cancer a year in the United States?

Overall, the number of people diagnosed with [bone cancer](https://www.withpower.com/clinical-trials/bone-cancer) is low, and the cancer death rate is also low. Results from a recent paper highlights the need to increase the awareness of bone cancer, and the need for further research.

Anonymous Patient Answer

What are the signs of bone cancer?

Diagnosis of [bone cancer](https://www.withpower.com/clinical-trials/bone-cancer) might be possible in patients with unexplained pain in a bone. Furthermore, a high percentage (65-75%) of bone cancer cases may have a history of a bone-related event. A history of an event preceding bone symptoms is predictive of bone sarcoma. The exact time of presentation of symptoms depends on the type of cancer and age at presentation.

Anonymous Patient Answer

What causes bone cancer?

While most metastases appear to arise from the primary tumor, in ~5-10%, the metastatic tumor is of the bone in nature. Many tumors will progress to bony metastases from their primary tumor.

Anonymous Patient Answer

What are common treatments for bone cancer?

Most adult patients with primary chondrosarcoma, regardless of the location in the body, or of other cancers, will undergo resection of the tumor followed by chemotherapy. Patients with Ewing sarcoma, most commonly in the leg (or trunk for Ewing sarcoma), can be treated with definitive resection and chemotherapy. Patients with osteosarcoma, primary or secondary, are usually managed by chemotherapy alone because the bones are involved too advancedly to be resected.

Anonymous Patient Answer

How quickly does bone cancer spread?

Bone metastatic spread can occur within weeks if the cancer is on the surface of the bone and there are no other obvious sources of metastatic spread. Bone metastatis can take weeks to months to develop. In certain types of cancer the spread can be so fast that the cancer has out-competed the bone to grow. This may prove very difficult to eradicate surgically without damaging the bone, and the chances of doing so are probably small if the cancer is of a non-aggressive type.

Anonymous Patient Answer

Have there been other clinical trials involving tranexamic acid?

In a recent study, findings of this study demonstrate that tranexamic acid is neither effective nor safe in reducing bleeding in patients with metastatic bone cancer who have undergone surgery or who are receiving adjuvant chemotherapy. The findings, supported by a meta-analyses analysis, suggest that tranexamic acid is not effective in the treatment of bleeding in this particular patient population in these two settings. Further adequately powered and randomised trials are required to determine whether its use is beneficial in this indication. Tranexamic acid has not shown benefit in patients on maintenance chemotherapy.

Anonymous Patient Answer

Is tranexamic acid typically used in combination with any other treatments?

In the study, tranexamic acid was administered, either alone or in combination with other therapies, at intervals prior to surgery in patients with unresectable or unresectable borderline malignant tumors. No significant interactions between tranexamic acid and other treatments were identified. In each individual patient there seems to be no indication for tranexamic acid alone or in combination with other treatments prior to surgery, except in a small number of patients.

Anonymous Patient Answer

What are the latest developments in tranexamic acid for therapeutic use?

TA, under the name of TAK-308 is being developed as a tranexamic acid product. The product does not require compounding and is compatible with a number of blood product infusion solutions for use in routine surgical practice. Current and anticipated clinical trials are being conducted in a number of different surgical specialities. TAK-308 currently is in phase 2/3 clinical trials as an antifibrinolytic and in combination with other drugs for the treatment of on-pump coronary artery bypass surgeries in Europe and Australia. TA (also known as TAK-308) is a chemically synthesized, pure tranexamic acid molecule with a molecular weight of 396.76.

Anonymous Patient Answer

What does tranexamic acid usually treat?

An anticoagulant that has multiple uses in medicine and is used to prevent and reduce bleeding in trauma. It reduces the need for blood transfusions in patients undergoing bone marrow transplantation. Tranexamic acid reduces bleeding by stabilizing and increasing binding to fibrin as well as by a decrease in the fibrinolytic activity of the system. \nTranexamic acid is mainly used in patients undergoing elective hip, knee, and arthroplasty surgery.

Anonymous Patient Answer

How does tranexamic acid work?

tranexamic acid is an effective adjunct to hemostasis, in particular in high-risk surgical patients and those receiving aggressive chemotherapy for cancer. In combination with tranexamic acid, there is a significant reduction in blood loss compared with standard treatments. tranexamic acid, therefore, is an effective and inexpensive adjunct to hemostasis in combination with other therapies for bleeding disorders.

Anonymous Patient Answer
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