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Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

Primary Purpose

Musculoskeletal Cancer, Sarcoma,Soft Tissue

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid (TXA)
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

No Intervention

Arm Label

Bony tumor treated with Tranexamic acid (TXA)

Bony tumor treated without TXA

Soft tissue sarcoma treated with Tranexamic Acid (TXA)

Soft tissue sarcoma treated without TXA

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Perioperative blood loss
Perioperative blood loss measured by the hemoglobin balance method at postoperative days 1-3.

Secondary Outcome Measures

Blood transfusion rates
Number of required blood transfusions up to 3 days following surgery
Surgical drain output
Surgical drain output as measured in ml for 3 days following surgery

Full Information

First Posted
April 6, 2020
Last Updated
May 23, 2022
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04347122
Brief Title
Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction
Official Title
Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Cancer, Sarcoma,Soft Tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bony tumor treated with Tranexamic acid (TXA)
Arm Type
Active Comparator
Arm Description
This group of participants will undergo a bony tumor resection of the femur or proximal tibia and endoprosthetic reconstruction with TXA.
Arm Title
Bony tumor treated without TXA
Arm Type
No Intervention
Arm Description
This group of participants will undergo a bony tumor resection of the femur of proximal tibia and endoprosthetic reconstruction.
Arm Title
Soft tissue sarcoma treated with Tranexamic Acid (TXA)
Arm Type
Active Comparator
Arm Description
This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA
Arm Title
Soft tissue sarcoma treated without TXA
Arm Type
No Intervention
Arm Description
This group of participants will undergo soft tissue sarcoma resection of the lower extremity.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid (TXA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perioperative blood loss
Description
Perioperative blood loss measured by the hemoglobin balance method at postoperative days 1-3.
Time Frame
Postoperative days 1-3
Secondary Outcome Measure Information:
Title
Blood transfusion rates
Description
Number of required blood transfusions up to 3 days following surgery
Time Frame
Postoperative days 1-3
Title
Surgical drain output
Description
Surgical drain output as measured in ml for 3 days following surgery
Time Frame
Postoperative days 1-3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
S Bradshaw
Phone
913-945-6289
Email
sbradshaw2@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Sweeney, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Bradshaw
Phone
913-945-6289
Email
sbradshaw2@kumc.edu
First Name & Middle Initial & Last Name & Degree
K Sweeney

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

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