Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02706249|
Recruitment Status : Completed
First Posted : March 11, 2016
Last Update Posted : August 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Venous Thormboembolism||Drug: Enoxaparin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Phase II Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||March 7, 2019|
|Actual Study Completion Date :||March 7, 2019|
Active Comparator: 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.
Other Name: Lovenox
Active Comparator: 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.
Other Name: Lovenox
- Cumulative incidence of VTE in standard dose enoxaparin arm [ Time Frame: 17 days ]
- Cumulative incidence of major hemorrhage in weight-adjusted enoxaparin arm and standard dose enoxaparin arm [ Time Frame: 14 days ]
- Cumulative incidence of symptomatic VTE [ Time Frame: 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706249
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Jeffrey Zwicker, MD||Beth Israel Deaconess Medical Center|