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Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347122
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Kyle Sweeney, MD, 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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Cancer Sarcoma,Soft Tissue Drug: Tranexamic Acid (TXA) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Participant)
Primary Purpose: Treatment
Official Title: Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction: A Randomized Controlled Trial
Actual Study Start Date : January 28, 2020
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Perioperative blood loss [ Time Frame: Postoperative days 1-3 ]
    Perioperative blood loss measured by the hemoglobin balance method at postoperative days 1-3.


Secondary Outcome Measures :
  1. Blood transfusion rates [ Time Frame: Postoperative days 1-3 ]
    Number of required blood transfusions up to 3 days following surgery

  2. Surgical drain output [ Time Frame: Postoperative days 1-3 ]
    Surgical drain output as measured in ml for 3 days following surgery



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347122


Contacts
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Contact: S Bradshaw 913-945-6289 sbradshaw2@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: S Bradshaw    913-945-6289    sbradshaw2@kumc.edu   
Principal Investigator: K Sweeney         
Sponsors and Collaborators
University of Kansas Medical Center
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Responsible Party: Kyle Sweeney, MD, Principal Investigator, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04347122    
Other Study ID Numbers: 00144738
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants