Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients
Condition: Venous Thormboembolism
Intervention: Enoxaparin
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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