Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

Sarcoma,Soft Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347122
• Other study ID #: 00144738
• Status: Completed
• Phase: Phase 4
• Start date: January 28, 2020
• Est. completion date: August 18, 2023

Study information

• Verified date: November 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Cancer
• Sarcoma
• Sarcoma,Soft Tissue

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative blood loss	Perioperative blood loss measured by the hemoglobin balance method at postoperative days 1-3.	Postoperative days 1-3
Secondary	Blood transfusion rates	Number of required blood transfusions up to 3 days following surgery	Postoperative days 1-3
Secondary	Surgical drain output	Surgical drain output as measured in ml for 3 days following surgery	Postoperative days 1-3