Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-28

Study Completion Date

2023-08-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Musculoskeletal Cancer Sarcoma,Soft Tissue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Tranexamic Acid (TXA)

Intervention Type 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 without TXA

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Soft tissue sarcoma treated with Tranexamic Acid (TXA)

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

Group Type ACTIVE_COMPARATOR

Tranexamic Acid (TXA)

Intervention Type 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.

Soft tissue sarcoma treated without TXA

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No