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recruitment stalled
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Soft tissue sarcoma treated without TXA | No Intervention | This group of participants will undergo soft tissue sarcoma resection of the lower extremity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Blood Loss | How much blood was lost during surgical process | During surgical procedure, 4 to 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Sweeney, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bony Tumor w/ TXA Group | bony tumor that will receive TXA |
| FG001 | Bony Tumor no TXA Group | bony tumor with no TXA treatment |
| FG002 | Soft Tissue Tumor w/ TXA Group | soft tissue tumor that will receive TXA |
| FG003 | Soft Tissue Tumor With no TXA Group | soft tissue tumor with no TXA |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Enrollment was terminated, study was closed due to low enrollment, therefore no data were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bony Tumor Treated With Tranexamic Acid (TXA) | This group of participants will undergo a bony tumor resection of the femur or proximal tibia and endoprosthetic reconstruction with TXA. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Perioperative Blood Loss | How much blood was lost during surgical process | Bony tumor w/ TXA group had no participants | Posted | Mean | Full Range | mL | During surgical procedure, 4 to 6 hours |
|
up to 3 days
There were no subjects in Bony tumor w/ TXA group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bony Tumor w/ TXA Group | Participants received TXA | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyle Sweeney, MD | KUMC | 913886100 | ksweeney2@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2019 | Jan 6, 2025 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2022 | Oct 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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.
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| BG001 |
| Bony Tumor Treated Without TXA |
This group of participants will undergo a bony tumor resection of the femur of proximal tibia and endoprosthetic reconstruction. |
| BG002 | Soft Tissue Sarcoma Treated With Tranexamic Acid (TXA) | This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA 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. |
| BG003 | Soft Tissue Sarcoma Treated Without TXA | This group of participants will undergo soft tissue sarcoma resection of the lower extremity. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG003 | Soft Tissue Tumor With no TXA Group | soft tissue tumor with no TXA |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Bony Tumor no TXA Group | Participants did not receive TXA | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Soft Tissue Tumor w/ TXA Group | Participants received TXA | 0 | 3 | 0 | 3 | 0 | 3 |
| EG003 | Soft Tissue Tumor With no TXA Group | Participants did not receive TXA | 0 | 6 | 0 | 6 | 0 | 6 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|