Phase 2 N=50 Randomized Double-blind Treatment

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

Venous Thormboembolism

Bottom Line

View on ClinicalTrials.gov: NCT02706249 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days — 2 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Enoxaparin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dana-Farber Cancer Institute
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days	2	—
PRIMARY Number Participants With Major Hemorrhage	1; 0	—
SECONDARY Number of Symptomatic Venous Thromboembolic Events (VTE)	0; 0	—

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 1.2 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02706249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.