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

NCT02706249 | Completed Phase 2 Results DMC

• 1 other identifier: 15-547
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Venous Thormboembolism

Outcome Measures

Primary Outcomes (2)

• Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days

  To investigate the numbers of VTE in hospitalized cancer patients receiving standard dose

  17 days only measured in Arm A (Standard dose enoxaparin)

• Number Participants With Major Hemorrhage

  Number of major hemorrhage in weight-adjusted enoxaparin arm and standard-dose enoxaparin arm

  14 days

Secondary Outcomes (1)

• Number of Symptomatic Venous Thromboembolic Events (VTE)

  14 days

Study Arms (2)

A: Standard Dose Enoxaparin

ACTIVE COMPARATOR

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.

Drug: Enoxaparin

B: Weight Adjusted Enoxaparin

ACTIVE COMPARATOR

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.

Drug: Enoxaparin

Interventions

Enoxaparin DRUG

Also known as: Lovenox

A: Standard Dose Enoxaparin; B: Weight Adjusted Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 32442298 DERIVED

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Jeffrey Zwicker, Division of Thrombosis and Haemostasis, Division of Hematology and Oncology
• Organization: Beth Israel Deaconess Medical Center, Harvard Medical School

jzwicker@bidmc.harvard.edu

617.667.9299

Study Officials

• Jeffrey Zwicker, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jeffrey Zwicker, MD

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 11, 2016
• Study Start: April 1, 2016
• Primary Completion: December 7, 2020
• Study Completion: June 7, 2021
• Last Updated: July 8, 2021
• Results First Posted: June 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)