Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

Phase 4

Terminated

• Conditions: Musculoskeletal Cancer; Sarcoma,Soft Tissue
• Interventions: Drug: Tranexamic Acid (TXA)

• Registration Number: NCT04347122
• Lead Sponsor: University of Kansas Medical Center

Brief 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.

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 Timeline

• Study Start: 2020-01-28
• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-15
• Primary Completion: 2023-08-18
• Study Completion: 2023-08-18
• Results First Submitted: 2024-11-03
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Results First Posted: 2025-05-21
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bony tumor treated with Tranexamic acid (TXA)	Tranexamic Acid (TXA)	This group of participants will undergo a bony tumor resection of the femur or proximal tibia and endoprosthetic reconstruction with TXA.
Soft tissue sarcoma treated with Tranexamic Acid (TXA)	Tranexamic Acid (TXA)	This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA

Primary Outcome Measures

Name	Time	Method
Perioperative Blood Loss	During surgical procedure, 4 to 6 hours	How much blood was lost during surgical process

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States