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

Venous Thormboembolism Clinical Trial

Official title:

A Randomized, Phase II Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706249
• Other study ID #: 15-547
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: June 7, 2021

Study information

• Verified date: July 2021
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 7, 2021
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Venous Thormboembolism

Intervention

Drug:
• Enoxaparin

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Number Participants With Major Hemorrhage	Number of major hemorrhage in weight-adjusted enoxaparin arm and standard-dose enoxaparin arm	14 days
Secondary	Number of Symptomatic Venous Thromboembolic Events (VTE)	Comparing number of symptomatic VTE (data collected prior to unblinding) for the standard dose (Arm A) versus intermediate dose enoxaparin (Arm B).	14 days