Dalteparin in Preventing DVT in Participants With Cancer

Lymphoma Clinical Trial

Official title:

DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525057
• Other study ID #: 2004-0743
• Secondary ID: NCI-2018-0184820
• Status: Completed
• Phase: N/A
• Start date: July 7, 2006
• Est. completion date: June 19, 2020

Study information

• Verified date: December 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 19, 2020
• Est. primary completion date: June 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Sarcoma
• Femur Fracture
• Fractures, Bone
• Lymphoma
• Metastatic Neoplasm
• Multiple Myeloma
• Neoplasm Metastasis
• Pathologic Fracture
• Plasma Cell Myeloma
• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• Dalteparin
Given SC

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	4 weeks after surgery
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.	4 weeks after surgery
Secondary	Post-Operative Blood Transfusion	The volume of packed red blood cell transfusion in the post-operative period	4 weeks after surgery

External Links

•   MD Anderson Cancer Center Website