A Phase 4 interventional study of Tranexamic Acid (TXA) in Musculoskeletal Cancer and Sarcoma,Soft Tissue, sponsored by University of Kansas Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by University of Kansas Medical Center · Phase 4, Interventional, and Treatment
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.
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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →University of Kansas Medical Center is the lead sponsor of 484 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group of participants will undergo a bony tumor resection of the femur or proximal tibia and endoprosthetic reconstruction with TXA.
Drug: Tranexamic Acid (TXA)
This group of participants will undergo a bony tumor resection of the femur of proximal tibia and endoprosthetic reconstruction.
This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA
Drug: Tranexamic Acid (TXA)
This group of participants will undergo soft tissue sarcoma resection of the lower extremity.
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.
Perioperative Blood Loss
How much blood was lost during surgical process
Time frame: During surgical procedure, 4 to 6 hours
| Milestone | Bony Tumor w/ TXA Group | Bony Tumor no TXA Group | Soft Tissue Tumor w/ TXA Group | Soft Tissue Tumor With no TXA Group |
|---|---|---|---|---|
| Started | 0 | 3 | 3 | 6 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 3 | 3 | 6 |
| Withdrew: Physician decision | 0 | 3 | 3 | 6 |
How much blood was lost during surgical process
| mL | Bony Tumor w/ TXA Group | Bony Tumor no TXA Group | Soft Tissue Tumor w/ TXA Group | Soft Tissue Tumor With no TXA Group |
|---|---|---|---|---|
| Perioperative Blood Loss | — | 283 (250 to 350) | 700 (100 to 1800) | 416 (100 to 700) |
Collected over up to 3 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bony Tumor w/ TXA Group | — | — | — |
| Bony Tumor no TXA Group | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Soft Tissue Tumor w/ TXA Group | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Soft Tissue Tumor With no TXA Group | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
Enrollment was terminated, study was closed due to low enrollment, therefore no data were analyzed.
| Age, Categorical(Participants) | Bony Tumor Treated With Tranexamic Acid (TXA) | Bony Tumor Treated Without TXA | Soft Tissue Sarcoma Treated With Tranexamic Acid (TXA) | Soft Tissue Sarcoma Treated Without TXA | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 3 | 3 | 6 | 12 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Bony Tumor Treated With Tranexamic Acid (TXA) | Bony Tumor Treated Without TXA | Soft Tissue Sarcoma Treated With Tranexamic Acid (TXA) | Soft Tissue Sarcoma Treated Without TXA | Total |
|---|---|---|---|---|---|
| Female | 0 | 1 | 1 | 3 | 5 |
| Male | 0 | 2 | 2 | 3 | 7 |
| Race and Ethnicity Not Collected(Participants) | Bony Tumor Treated With Tranexamic Acid (TXA) | Bony Tumor Treated Without TXA | Soft Tissue Sarcoma Treated With Tranexamic Acid (TXA) | Soft Tissue Sarcoma Treated Without TXA | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
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University of Kansas Medical Center