Musculoskeletal CancerPhase 4NCT04347122
Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction
A Phase 4 study testing Tranexamic Acid (TXA) in people with Musculoskeletal Cancer and Sarcoma,Soft Tissue, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This study intends to determine if any correlation exists between administration of TXA or not to musculoskeletal oncology patients undergoing endoprosthetic reconstruction and blood loss and blood transfusion rates. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Musculoskeletal Cancer, Sarcoma,Soft Tissue
- What is being tested?
- Tranexamic Acid (TXA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 18 Aug 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing wide resection of a malignant bony tumor of the lower extremity with endoprosthetic reconstruction.
- Patients undergoing a resection of soft tissue sarcoma measuring > 5cm.
Who cannot join
- Patients undergoing revision endoprosthetic reconstruction
- Patients with known coagulopathy
- Known history of DVT or embolic disease
- Benign tumors
- Patients with allergy to TXA
- Those refusing blood products
Show all 9Show fewer
- Those concurrently on anti-coagulant therapy
- Pregnant and/or nursing women
- Vulnerable populations as defined by the KUMC IRB
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction: A Randomized Controlled Trial
This study intends to determine if any correlation exists between administration of TXA or not to musculoskeletal oncology patients undergoing endoprosthetic reconstruction and blood loss and blood transfusion rates.
Read the detailed description
Resection of bony and soft tissue tumors with endoprosthetic reconstruction often presents a significant risk of perioperative blood loss requiring transfusion. Tranexamic acid (TXA) is an antifibrinolytic that is commonly used to reduce blood loss in orthopedic procedures, most often arthroplasty. The aim of this study is to determine in a randomized controlled fashion if there is any difference in perioperative blood loss and blood transfusion rates when TXA is used compared to when it is not used in patients undergoing radical resection of bone and soft tissue sarcomas with endoprosthetic reconstruction.
- Conditions
- Musculoskeletal Cancer, Sarcoma,Soft Tissue
- Being tested
- Tranexamic Acid (TXA)
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA)Drug
Intervention groups will receive TXA 1g TXA IVPB 10 minutes prior to incision and a second dose of 1g IVPB at the time of closure.
| Study group | Role | What they receive |
|---|---|---|
| Bony tumor treated with Tranexamic acid (TXA) | Active comparator | This group of participants will undergo a bony tumor resection of the femur or proximal tibia and endoprosthetic reconstruction with TXA. Receives: Drug: Tranexamic Acid (TXA) |
| Bony tumor treated without TXA | No intervention | This group of participants will undergo a bony tumor resection of the femur of proximal tibia and endoprosthetic reconstruction. |
| Soft tissue sarcoma treated with Tranexamic Acid (TXA) | Active comparator | This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA Receives: Drug: Tranexamic Acid (TXA) |
| Soft tissue sarcoma treated without TXA | No intervention | This group of participants will undergo soft tissue sarcoma resection of the lower extremity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Blood Loss
How much blood was lost during surgical process
Measured: During surgical procedure, 4 to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start28 Jan 2020
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Why it stopped: recruitment stalled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Musculoskeletal CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to one of four groups. One group is the bony tumor treated with TXA, second group is the bony tumor treated without TXA, third group is the soft tissue sarcoma treated with TXA, and the fourth group is soft tissue sarcoma treated without TXA.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Sweeney, MD, University of Kansas Medical Center
- Investigators
- Kyle Sweeney, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347122
- Sponsor's protocol ID
- 00144738
- Status last verified
- May 2025
- First submitted
- 6 Apr 2020
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04347122
- Acronym / sponsor ID
- 00144738
- Conditions
- Musculoskeletal Cancer, Sarcoma,Soft Tissue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment stalled
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to determine if any correlation exists between administration of TXA or not to musculoskeletal oncology patients undergoing endoprosthetic reconstruction and blood loss and blood transfusion rates.
Detailed description
Resection of bony and soft tissue tumors with endoprosthetic reconstruction often presents a significant risk of perioperative blood loss requiring transfusion. Tranexamic acid (TXA) is an antifibrinolytic that is commonly used to reduce blood loss in orthopedic procedures, most often arthroplasty. The aim of this study is to determine in a randomized controlled fashion if there is any difference in perioperative blood loss and blood transfusion rates when TXA is used compared to when it is not used in patients undergoing radical resection of bone and soft tissue sarcomas with endoprosthetic reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants are randomized to one of four groups. One group is the bony tumor treated with TXA, second group is the bony tumor treated without TXA, third group is the soft tissue sarcoma treated with TXA, and the fourth group is soft tissue sarcoma treated without TXA.
| Arm | Type | Receives |
|---|---|---|
| Bony tumor treated with Tranexamic acid (TXA) | Active comparator | Drug: Tranexamic Acid (TXA)This group of participants will undergo a bony tumor resection of the femur or proximal tibia and endoprosthetic reconstruction with TXA. |
| Bony tumor treated without TXA | No intervention | –This group of participants will undergo a bony tumor resection of the femur of proximal tibia and endoprosthetic reconstruction. |
| Soft tissue sarcoma treated with Tranexamic Acid (TXA) | Active comparator | Drug: Tranexamic Acid (TXA)This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA |
| Soft tissue sarcoma treated without TXA | No intervention | –This group of participants will undergo soft tissue sarcoma resection of the lower extremity. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing wide resection of a malignant bony tumor of the lower extremity with endoprosthetic reconstruction.
- Patients undergoing a resection of soft tissue sarcoma measuring > 5cm.
Key exclusion criteria (9 listed)
- Patients undergoing revision endoprosthetic reconstruction
- Patients with known coagulopathy
- Known history of DVT or embolic disease
- Benign tumors
- Patients with allergy to TXA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (TXA)Intervention groups will receive TXA 1g TXA IVPB 10 minutes prior to incision and a second dose of 1g IVPB at the time of closure. | Drug | Bony tumor treated with Tranexamic acid (TXA), Soft tissue sarcoma treated with Tranexamic Acid (TXA) |
Primary outcome
Perioperative Blood Loss
Time frame: During surgical procedure, 4 to 6 hours
How much blood was lost during surgical process
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Sweeney, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid (TXA) in people with Musculoskeletal Cancer and Sarcoma,Soft Tissue, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Blood Loss (time frame: During surgical procedure, 4 to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.