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

Phase 2

Completed

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
A: Standard Dose Enoxaparin	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.
B: Weight Adjusted Enoxaparin	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.

Primary Outcome Measures

Name	Time	Method
Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days	17 days only measured in Arm A (Standard dose enoxaparin)	To investigate the numbers of VTE in hospitalized cancer patients receiving standard dose
Number Participants With Major Hemorrhage	14 days	Number of major hemorrhage in weight-adjusted enoxaparin arm and standard-dose enoxaparin arm

Secondary Outcome Measures

Name	Time	Method
Number of Symptomatic Venous Thromboembolic Events (VTE)	14 days	Comparing number of symptomatic VTE (data collected prior to unblinding) for the standard dose (Arm A) versus intermediate dose enoxaparin (Arm B).

Locations (2): Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Cleveland Clinic Foundation
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Cleveland, Ohio, United States