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

• Status: Completed
• Trial end date: 2021-06-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Enoxaparin

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