Clinical trial NCT02706249: Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients
Official title: A Randomized, Phase II Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thormboembolism
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days
timeFrame: 17 days only measured in Arm A (Standard dose enoxaparin)
measure: Number Participants With Major Hemorrhage
timeFrame: 14 days
Secondary outcomes:
measure: Number of Symptomatic Venous Thromboembolic Events (VTE)
timeFrame: 14 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Jeffrey Zwicker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zwicker JI, Roopkumar J, Puligandla M, Schlechter BL, Sharda AV, Peereboom D, Joyce R, Bockorny B, Neuberg D, Bauer KA, Khorana AA. Dose-adjusted enoxaparin thromboprophylaxis in hospitalized cancer patients: a randomized, double-blinded multicenter phase 2 trial. Blood Adv. 2020 May 26;4(10):2254-2260. doi: 10.1182/bloodadvances.2020001804.