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Dalteparin in Preventing DVT in Participants With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00525057
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Bone Sarcoma Femur Fracture Lymphoma Metastatic Neoplasm Pathologic Fracture Plasma Cell Myeloma Soft Tissue Sarcoma Drug: Dalteparin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study
Actual Study Start Date : July 7, 2006
Actual Primary Completion Date : June 19, 2020
Actual Study Completion Date : June 19, 2020


Arm Intervention/treatment
Experimental: Treatment (dalteparin)
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
Given SC




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 4 weeks after surgery ]
    Knowledge gained from the treatment of these participants will be used to design larger, more definitive studies



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525057


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Patrick Lin M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00525057    
Other Study ID Numbers: 2004-0743
NCI-2018-01848 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2004-0743 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Multiple Myeloma
Neoplasm Metastasis
Fractures, Bone
Fractures, Spontaneous
Wounds and Injuries
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Dalteparin
Tinzaparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action