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

NCT ID: NCT02706249

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2021-06-07

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.

Conditions

Venous Thormboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A: Standard Dose 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.

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

B: Weight Adjusted 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.

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

Interventions

Enoxaparin

Intervention Type: DRUG

Other Intervention Names

Lovenox

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Zwicker, MD

Jeffrey Zwicker, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Zwicker, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32442298 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-547

Identifier Type: -

Identifier Source: org_study_id