Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcoma,Soft Tissue; Musculoskeletal Cancer
• Intervention / Treatment: Drug: Tranexamic Acid (TXA)

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: S Bradshaw; Phone Number: 913-945-6289; Email: sbradshaw2@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University Of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.
No Intervention: Bony tumor treated without TXA; 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); This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA	Drug: 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.
No Intervention: Soft tissue sarcoma treated without TXA; This group of participants will undergo soft tissue sarcoma resection of the lower extremity.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Kyle Sweeney, MD, University Of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): August 18, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 00144738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes