Neoplasms

Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Rare Diseases

Neoplasm Metastasis

Sarcoma

Thromboembolism

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Soft Tissue Sarcoma

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Anticoagulants

Aspirin

Enoxaparin

Enoxaparin sodium

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

acetylsalicylic acid

enoxaparin

Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Joel Mayerson, MD

This is a research study to compare the efficacy of aspirin (acetylsalicylic acid) and pneumatic compression devices versus enoxaparin (also known as Lovenox) and pneumatic compression devices in preventing deep vein thrombosis in patients with pelvic and lower extremity malignant tumors and undergoing surgery. Pneumatic compression devices are also known as sequential compression devices and are inflatable compression sleeves that are placed around patient's legs to reduce the risk of clot formation deep vein thrombosis. Pneumatic compression devices are made of a soft material that wraps around the lower leg and periodically squeeze the calf. A deep vein thrombosis is a blood clot. Most hospitalized patients wear these as a preventive measure. Pneumatic compression devices alone are not sufficient to prevent deep vein thrombosis formation. Therefore, medicines, such as aspirin and enoxaparin are utilized. Both drugs are used for prevention, but there are no studies in patients with musculoskeletal tumors which have determined whether one drug is better than another. The knowledge gained from this study will determine whether aspirin and pneumatic compression devices is the same or better than enoxaparin and pneumatic compression devices in preventing deep vein thrombosis in this patient population and may result in fewer wound and bleeding complications

PRIMARY OBJECTIVES:

I. To perform a randomized prospective study to determine efficacy of acetylsalicylic acid (ASA)+pneumatic compression device (PCD) prophylaxis compared to low-molecular weight heparin (LMWH)+PCD in patients undergoing orthopaedic procedures for musculoskeletal neoplasms (MSN) of the pelvis and lower extremity.

II. To prove that ASA+PCD is clinically equivalent to or better than LMWH+PCD in providing deep vein thrombosis (DVT) prophylaxis in this patient population and results in fewer major bleeding complications.

III. To measure rates of postoperative DVT and pulmonary embolism (PE) as primary outcomes.

SECONDARY OBJECTIVES:

I. To measure secondary outcomes including rates of readmission, reoperation, bleeding complications (including hematoma formation and prolonged wound drainage), and death.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive acetylsalicylic acid orally (PO) twice daily (BID) and wear PCD on days 1-28 after surgery.

ARM II: Patients receive enoxaparin subcutaneously (SC) once daily (QD) and wear PCD on days 1-28 after surgery.

After completion of study treatment, patients are followed up at 2 weeks, 6 weeks, and 3 months.

Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology

This study will test if the ASA+PCD treatment group has a DVT rate (P1) not more than the DVT rate of the LMWH+PCD treatment group (P0) using a one sided test for these two proportions. Statistical significance will be defined as p \< 0.05.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

acetylsalicylic acid: 325 mg twice a day

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Arm I (Acetylsalicylic Acid and PCD)

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

enoxaparin: 40 mg once daily

PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.

Arm II (Enoxaparin and PCD)

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Overall patient compliance for the study was low

DVT Incident Rate

Pulmonary Embolism Rate

Development of Other Complications (Including Bleeding Complications)

Readmission Rate to Hopsital

Hematoma Formation

Excessive Wound Drainage

Death Rate

Overall Study

Coagulants

Tranexamic Acid

Antifibrinolytic Agents

Hemostatics

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.

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.

Tranexamic Acid (TXA)

Kyle Sweeney, MD

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.

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.

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.

Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

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

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

Number of required blood transfusions up to 3 days following surgery

Surgical drain output as measured in ml for 3 days following surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology	NCT01696760	Bone Metastases Musculoskeletal... Soft Tissue Sar... Thromboembolism	acetylsalicylic... enoxaparin PCD	18 Years -	Ohio State University Comprehensive Cancer Center
Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction	NCT04347122	Musculoskeletal... Sarcoma,Soft Ti...	Tranexamic Acid...	18 Years - 90 Years	University of Kansas Medical Center
Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction	NCT04347122	Musculoskeletal... Sarcoma,Soft Ti...	Tranexamic Acid...	18 Years - 90 Years	University of Kansas Medical Center
Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction	NCT04347122	Musculoskeletal... Sarcoma,Soft Ti...	Tranexamic Acid...	18 Years - 90 Years	University of Kansas Medical Center

Spots Global Cancer Trial Database for musculoskeletal cancer