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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 4
Study Type
Interventional
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.
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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.

More Details

Status
Completed
Sponsor
University of Kansas Medical Center

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.