Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

University of Kansas

Status and phase: Terminated; Phase 4

Conditions: Musculoskeletal Cancer; Sarcoma,Soft Tissue

Treatments: Drug: Tranexamic Acid (TXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04347122

00144738

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 4 patient groups

Bony tumor treated with Tranexamic acid (TXA)

Active Comparator group

Description:

This group of participants will undergo a bony tumor resection of the femur or proximal tibia and endoprosthetic reconstruction with TXA.

Treatment:

Drug: Tranexamic Acid (TXA)

Bony tumor treated without TXA

No Intervention group

Description:

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 group

Description:

This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA

Treatment:

Drug: Tranexamic Acid (TXA)

Soft tissue sarcoma treated without TXA

No Intervention group

Description:

This group of participants will undergo soft tissue sarcoma resection of the lower extremity.