Dalteparin in Preventing DVT in Participants With Cancer

NCT00525057 | Completed Results FDA Drug

• 2 other identifiers: 2004-0743NCI-2018-01848
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Sarcoma; Femur Fracture; Lymphoma; Metastatic Neoplasm; Pathologic Fracture; Plasma Cell Myeloma; Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Occurrence of Venous Thromboembolism

  4 weeks after surgery

• Post-Operative Blood Transfusion

  4 weeks after surgery

Study Arms (1)

Treatment (dalteparin)

EXPERIMENTAL

Participants receive dalteparin SC QD starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.

Drug: Dalteparin

Interventions

Dalteparin DRUG

Given SC

Treatment (dalteparin)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Bone Neoplasms; Femoral Fractures; Lymphoma; Neoplasm Metastasis; Fractures, Spontaneous; Multiple Myeloma; Sarcoma

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Patrick Lin, MD/Professor, Orthopaedic Oncology
• Organization: UT MD Anderson Cancer Center

plin@mdanderson.org

(713) 745-0088

Study Officials

• Patrick Lin

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 5, 2007
• Study Start: July 7, 2006
• Primary Completion: June 19, 2020
• Study Completion: June 19, 2020
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2020-12

Locations

US (1)