Bone Sarcoma, Femur Fracture, Lymphoma, Metastatic Neoplasm, Pathologic Fracture, Plasma Cell Myeloma, Soft Tissue Sarcoma
Conditions
Brief summary
This trial studies how well dalteparin works in preventing deep vein thrombosis (DVT) (blood clots) in participants with cancer. Dalteparin is a blood thinner that can treat blood clots and may prevent them from forming.
Detailed description
PRIMARY OBJECTIVES: I. To determine the safety of dalteparin as prophylaxis against deep venous thrombosis (DVT) in orthopedic oncology patients. II. To determine whether there are significantly increased bleeding complications at the surgical site after major oncologic operations in the lower extremity. OUTLINE: Participants receive dalteparin subcutaneously (SC) once daily (QD) starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.
Interventions
DRUGDalteparin
Given SC
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* GROUP A * Metastatic disease, myeloma, lymphoma. * Pathologic fracture or impending pathologic fracture of the femur. * Intramedullary rod, plating, cementation, hip arthroplasty, or knee arthroplasty. * GROUP B * Primary sarcoma of bone or soft tissue of the lower extremity. * T2 tumor (\> 5 cm by \< 20 cm). * Radical resection of tumor, which may necessitate major bone or soft tissue reconstruction.
Exclusion criteria
* Presence of DVT on pre-operative screening ultrasound study. * Massive tumor (\> 20 cm in greatest dimension). * Amputation of the affected leg as treatment of tumor. * Estimated blood loss \> 2 liters during surgery. * Surgical drain output \> 500 cc of bloody fluid during first 8 hours. * International normalized ratio (I.N.R.) \> 1.3 pre-operatively or \> 1.5 post-operatively. * Platelet count \< 100,000 either pre-operatively or post-operatively. * Indwelling post-operative epidural catheter for pain control. * History of underlying bleeding disorder, such as hemophilia. * History of adverse reaction to heparin such as heparin-induced thrombocytopenia. * Severe liver or renal insufficiency. * History of hypertensive or diabetic retinopathy. * History of gastro-intestinal bleeding within 12 months. * Treatment with warfarin, clopidogrel, aspirin, nonsteroidal antiinflammatory drugs (NSAIDs), low molecular weight heparin (LMWH) or other anti-coagulants for conditions. * History of stroke. * Women of child bearing potential having a positive urine or serum pregnancy test (human chorionic gonadotropin \[hCG\]) at the time of pre-operative evaluation (within 7 days of surgery). * Women who are breastfeeding. * Hemoglobin \< 8.0 g/dL. * Platelet count \< 100,000/L. * Alanine aminotransferase \> 100 IU/L. * Aspartate aminotransferase \> 100 IU/L. * Direct bilirubin \> 0.5mg/dL. * Serum creatinine \> 2.0 mg/dL. * Patients taking COX-2 inhibitors. * Patients who have fragmented mechanical heart valves.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-operative Wound Complications | 4 weeks after surgery | Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Occurrence of Venous Thromboembolism | 4 weeks after surgery | A secondary outcome was the occurrence of venous thrombolembolism in the post-operative period, to include both deep venous thrombosis in the lower extremity as well as pulmonary embolism. |
| Post-Operative Blood Transfusion | 4 weeks after surgery | The volume of packed red blood cell transfusion in the post-operative period |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: July 2006 - December 2010
Pre-assignment details
A total of 65 participants enrolled into the trial. 15 participants did not meet entry criteria and were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Interventional (Dalteparin, Metastatic) Received dalteparin 5000 units daily postop, patients with metastatic disease. | 25 |
| Interventional (Dalteparin, Sarcoma) Received dalteparin 5000 units daily postop, patients with primary sarcomas. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Interventional (Dalteparin, Metastatic) | Interventional (Dalteparin, Sarcoma) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 21 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants | 25 Participants | 50 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 25 Participants | 25 Participants | 50 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 30 Participants |
| Surgery Curettage, Internal Fixation | 6 Participants | 0 Participants | 6 Participants |
| Surgery Segmental Reconstruction | 19 Participants | 5 Participants | 24 Participants |
| Surgery Wide Excision Only | 0 Participants | 20 Participants | 20 Participants |
| Tumor Location Femur/Thigh | 22 Participants | 15 Participants | 37 Participants |
| Tumor Location Popliteal | 3 Participants | 4 Participants | 7 Participants |
| Tumor Location Tibia/Calf | 0 Participants | 6 Participants | 6 Participants |
| Tumor Type Carcinoma | 25 Participants | 0 Participants | 25 Participants |
| Tumor Type Sarcoma | 0 Participants | 25 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 1 / 25 | 4 / 25 |
| serious Total, serious adverse events | 1 / 25 | 0 / 25 |
Outcome results
Primary
Number of Participants With Post-operative Wound Complications
Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma.
Time frame: 4 weeks after surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional (Dalteparin, Metastatic) | Number of Participants With Post-operative Wound Complications | Seroma | 1 Participants |
| Interventional (Dalteparin, Metastatic) | Number of Participants With Post-operative Wound Complications | Wound Infection | 0 Participants |
| Interventional (Dalteparin, Metastatic) | Number of Participants With Post-operative Wound Complications | Wound Dehiscence | 0 Participants |
| Interventional (Dalteparin, Sarcoma) | Number of Participants With Post-operative Wound Complications | Seroma | 4 Participants |
| Interventional (Dalteparin, Sarcoma) | Number of Participants With Post-operative Wound Complications | Wound Infection | 3 Participants |
| Interventional (Dalteparin, Sarcoma) | Number of Participants With Post-operative Wound Complications | Wound Dehiscence | 1 Participants |
Secondary
Number of Participants With Occurrence of Venous Thromboembolism
A secondary outcome was the occurrence of venous thrombolembolism in the post-operative period, to include both deep venous thrombosis in the lower extremity as well as pulmonary embolism.
Time frame: 4 weeks after surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional (Dalteparin, Metastatic) | Number of Participants With Occurrence of Venous Thromboembolism | Deep venous thrombosis | 1 Participants |
| Interventional (Dalteparin, Metastatic) | Number of Participants With Occurrence of Venous Thromboembolism | Pulmonary embolism | 0 Participants |
| Interventional (Dalteparin, Sarcoma) | Number of Participants With Occurrence of Venous Thromboembolism | Deep venous thrombosis | 0 Participants |
| Interventional (Dalteparin, Sarcoma) | Number of Participants With Occurrence of Venous Thromboembolism | Pulmonary embolism | 0 Participants |
Secondary
Post-Operative Blood Transfusion
The volume of packed red blood cell transfusion in the post-operative period
Time frame: 4 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Interventional (Dalteparin, Metastatic) | Post-Operative Blood Transfusion | 213 mL |
| Interventional (Dalteparin, Sarcoma) | Post-Operative Blood Transfusion | 271 mL |