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Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients

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: NCT02706249
Recruitment Status : Completed
First Posted : March 11, 2016
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey Zwicker, MD, Dana-Farber Cancer Institute

Brief Summary:
Hospitalized patients with histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma, or multiple myeloma and who are at high risk for a venous thromboembolism will be randomized to standard dose versus intermediate dose enoxaparin.

Condition or disease Intervention/treatment Phase
Venous Thormboembolism Drug: Enoxaparin Phase 2

Detailed Description:
In a phase II trial, high risk hospitalized cancer patients will be enrolled and randomized to standard dose enoxaparin versus intermediate dose (weight adjusted) enoxaparin thromboprophylaxis. Study subjects will be administered enoxaparin during hospitalization in a double-blinded manner. Following completion of 14 days, the study arms will be unblinded and lower extremity ultrasound performed on the standard dose enoxaparin arm in order to more accurately determine the overall cumulative incidence of thrombosis in this group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Phase II Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients
Study Start Date : April 2016
Actual Primary Completion Date : March 7, 2019
Actual Study Completion Date : March 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: A: Standard Dose Enoxaparin

Participants will receive Enoxaparin 40 mg subcutaneously once daily. On study Enoxaparin will be administered for up 14 days during hospitalization.

After the day 14 assessment, treatment arms will be un-blinded in order to appropriately schedule a bilateral lower extremity ultrasound for participants enrolled onto Arm A at day 17.

Drug: Enoxaparin
Other Name: Lovenox

Active Comparator: B: Weight Adjusted Enoxaparin

Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily. Participants who weigh more than 100kg will be capped at 100mg.

On study Enoxaparin will be administered for up 14 days during hospitalization.

Drug: Enoxaparin
Other Name: Lovenox




Primary Outcome Measures :
  1. Cumulative incidence of VTE in standard dose enoxaparin arm [ Time Frame: 17 days ]
  2. Cumulative incidence of major hemorrhage in weight-adjusted enoxaparin arm and standard dose enoxaparin arm [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Cumulative incidence of symptomatic VTE [ Time Frame: 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma or multiple myeloma.
  • Cancer diagnosis or received treatment (chemotherapy or radiotherapy) for malignancy within the previous 6 months
  • One or more Padua-based risk factor:

    • History of previous venous thromboembolic event (excluding superficial vein thrombosis)
    • Reduced mobility (ECOG performance status 3 or 4, see Appendix A)
    • Established hereditary thrombophilia (e.g. Factor V Leiden, G20210 prothrombin mutation, protein C or S deficiency, antithrombin deficiency).
    • Recent surgery within the last 30 days
    • Age ≥ 70 years
    • Congestive heart failure (NYHA class III or IV)
    • Complicated respiratory insufficiency (defined as an increased requirement for supplementary oxygen of at least 2L)
    • Acute myocardial infarction or ischemic stroke
    • Obesity (BMI ≥ 30)
    • Receiving hormonal agents (e.g. tamoxifen, estrogen, testosterone)
    • Acute infection (i.e. requiring antimicrobial therapy)
  • Age ≥ 18 years
  • Life expectancy of greater than 30 days
  • Platelet count ≥ 100,000/mcL
  • Creatinine < 1.5 mg/dL or estimated creatinine clearance ≥ 50 mL/min/1.73 m2
  • Ability to understand and the willingness to sign a written informed consent document
  • Weight between 50kg to 130 kg.

Exclusion Criteria:

  • History of allergic reactions attributed to heparin or low molecular weight heparin
  • Active bleeding or otherwise considered high risk for hemorrhage (e.g. known acute gastrointestinal ulcer)
  • Any history of significant hemorrhage (requiring hospitalization or transfusion) within the last 6 months (excluding hemorrhage during operative procedure).
  • History of heparin induced Thrombocytopenia
  • Presence of coagulopathy (PT or PTT> 1.2 x upper limit of normal)
  • Known diagnosis of disseminated intravascular coagulation
  • Currently receiving therapeutic anticoagulant therapy or dual antiplatelet therapy (eg. aspirin and clopidogrel)
  • Uncontrolled arterial hypertension (systolic blood pressure > 200mmHg, diastolic >110mmHg)
  • Active peptic ulcer disease
  • Bacterial Endocardititis
  • Received any type of Pharmacologic Thromboprophylaxis (e.g. low molecular weight heparin or heparin) for >48 hours during current hospitalization
  • Known brain metastases

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): NCT02706249


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jeffrey Zwicker, MD Beth Israel Deaconess Medical Center

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Responsible Party: Jeffrey Zwicker, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02706249    
Other Study ID Numbers: 15-547
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No