Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction: A Randomized Controlled Trial

Conditions
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Musculoskeletal Cancer, Sarcoma,Soft Tissue

Intervention / Treatment
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* Drug: Tranexamic Acid (TXA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 Those concurrently on anti-coagulant therapy Pregnant and/or nursing women Vulnerable populations as defined by the KUMC IRB

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bony tumor treated with Tranexamic acid (TXA)<br>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)<br>* 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.<br>|
| No Intervention: Bony tumor treated without TXA<br>This group of participants will undergo a bony tumor resection of the femur of proximal tibia and endoprosthetic reconstruction. | |
| Active Comparator: Soft tissue sarcoma treated with Tranexamic Acid (TXA)<br>This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA | Drug: Tranexamic Acid (TXA)<br>* 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.<br>|
| No Intervention: Soft tissue sarcoma treated without TXA<br>This group of participants will undergo soft tissue sarcoma resection of the lower extremity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss | Perioperative blood loss measured by the hemoglobin balance method at postoperative days 1-3. | Postoperative days 1-3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion rates | Number of required blood transfusions up to 3 days following surgery | Postoperative days 1-3 | 
| Surgical drain output | Surgical drain output as measured in ml for 3 days following surgery | Postoperative days 1-3 |