Dalteparin in Preventing DVT in Participants With Cancer

December 31, 2020 updated by: M.D. Anderson Cancer Center

DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Post-operative Wound Complications
Time Frame: 4 weeks after surgery
Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma.
4 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Occurrence of Venous Thromboembolism
Time Frame: 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.
4 weeks after surgery
Post-Operative Blood Transfusion
Time Frame: 4 weeks after surgery
The volume of packed red blood cell transfusion in the post-operative period
4 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Patrick Lin, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2006

Primary Completion (Actual)

June 19, 2020

Study Completion (Actual)

June 19, 2020

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 4, 2007

First Posted (Estimate)

September 5, 2007

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

December 31, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-0743 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2018-01848 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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