Clinical trial · Interventional
Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients
A Randomized, Phase II Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients
NCT02706249CI-TRIAL-00052590completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Venous Thormboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enoxaparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: Standard Dose Enoxaparin
- description
- 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.
- interventionNames
- Drug: Enoxaparin
- type
- ACTIVE_COMPARATOR
- label
- B: Weight Adjusted Enoxaparin
- description
- 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.
- interventionNames
- Drug: Enoxaparin
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZwicker 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. PMID 32442298