Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

NCT04347122 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 00144738
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Cancer; Sarcoma,Soft Tissue

Outcome Measures

Primary Outcomes (1)

• Perioperative Blood Loss

  How much blood was lost during surgical process

  During surgical procedure, 4 to 6 hours

Study Arms (4)

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.

Drug: Tranexamic Acid (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

Drug: Tranexamic Acid (TXA)

Soft tissue sarcoma treated without TXA

NO INTERVENTION

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

Interventions

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.

Bony tumor treated with Tranexamic acid (TXA); Soft tissue sarcoma treated with Tranexamic Acid (TXA)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Kyle Sweeney, MD
• Organization: KUMC

ksweeney2@kumc.edu

913886100

Study Officials

• Kyle Sweeney, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 15, 2020
• Study Start: January 28, 2020
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)