Trial Outcomes & Findings for Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients (NCT NCT02706249)
NCT ID: NCT02706249
Last Updated: 2021-07-08
Results Overview
To investigate the numbers of VTE in hospitalized cancer patients receiving standard dose
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
17 days only measured in Arm A (Standard dose enoxaparin)
Results posted on
2021-07-08
Participant Flow
Participant milestones
| Measure |
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.
Enoxaparin
|
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.
Enoxaparin
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluated for VTE and safety
Baseline characteristics by cohort
| Measure |
A: Standard Dose Enoxaparin
n=25 Participants
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.
Enoxaparin
|
B: Weight Adjusted Enoxaparin
n=25 Participants
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.
Enoxaparin
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=23 Participants • Evaluated for VTE and safety
|
0 Participants
n=24 Participants • Evaluated for VTE and safety
|
0 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=23 Participants • Evaluated for VTE and safety
|
16 Participants
n=24 Participants • Evaluated for VTE and safety
|
30 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Age, Categorical
>=65 years
|
9 Participants
n=23 Participants • Evaluated for VTE and safety
|
8 Participants
n=24 Participants • Evaluated for VTE and safety
|
17 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Sex: Female, Male
Female
|
19 Participants
n=23 Participants • Evaluated for VTE and safety
|
11 Participants
n=24 Participants • Evaluated for VTE and safety
|
30 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Sex: Female, Male
Male
|
4 Participants
n=23 Participants • Evaluated for VTE and safety
|
13 Participants
n=24 Participants • Evaluated for VTE and safety
|
17 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=23 Participants • Evaluated for VTE and safety
|
0 Participants
n=24 Participants • Evaluated for VTE and safety
|
0 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=23 Participants • Evaluated for VTE and safety
|
0 Participants
n=24 Participants • Evaluated for VTE and safety
|
0 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants • Evaluated for VTE and safety
|
0 Participants
n=24 Participants • Evaluated for VTE and safety
|
0 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=23 Participants • Evaluated for VTE and safety
|
2 Participants
n=24 Participants • Evaluated for VTE and safety
|
3 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
White
|
19 Participants
n=23 Participants • Evaluated for VTE and safety
|
18 Participants
n=24 Participants • Evaluated for VTE and safety
|
37 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=23 Participants • Evaluated for VTE and safety
|
0 Participants
n=24 Participants • Evaluated for VTE and safety
|
1 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=23 Participants • Evaluated for VTE and safety
|
4 Participants
n=24 Participants • Evaluated for VTE and safety
|
6 Participants
n=47 Participants • Evaluated for VTE and safety
|
|
Region of Enrollment
United States
|
23 Participants
n=23 Participants • Evaluated for VTE and safety
|
24 Participants
n=24 Participants • Evaluated for VTE and safety
|
47 Participants
n=47 Participants • Evaluated for VTE and safety
|
PRIMARY outcome
Timeframe: 17 days only measured in Arm A (Standard dose enoxaparin)Population: All patients who were randomized to the standard dose of enoxaparin
To investigate the numbers of VTE in hospitalized cancer patients receiving standard dose
Outcome measures
| Measure |
A: Standard Dose Enoxaparin
n=23 Participants
Participants will receive Enoxaparin 40 mg subcutaneously once daily.
|
B: Weight Adjusted Enoxaparin
Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily
|
|---|---|---|
|
Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: 14 daysNumber of major hemorrhage in weight-adjusted enoxaparin arm and standard-dose enoxaparin arm
Outcome measures
| Measure |
A: Standard Dose Enoxaparin
n=23 Participants
Participants will receive Enoxaparin 40 mg subcutaneously once daily.
|
B: Weight Adjusted Enoxaparin
n=24 Participants
Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily
|
|---|---|---|
|
Number Participants With Major Hemorrhage
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: The analysis data set is comprised of evaluated patients.
Comparing number of symptomatic VTE (data collected prior to unblinding) for the standard dose (Arm A) versus intermediate dose enoxaparin (Arm B).
Outcome measures
| Measure |
A: Standard Dose Enoxaparin
n=23 Participants
Participants will receive Enoxaparin 40 mg subcutaneously once daily.
|
B: Weight Adjusted Enoxaparin
n=24 Participants
Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily
|
|---|---|---|
|
Number of Symptomatic Venous Thromboembolic Events (VTE)
|
0 Participants
|
0 Participants
|
Adverse Events
A: Standard Dose Enoxaparin
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
B: Weight Adjusted Enoxaparin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A: Standard Dose Enoxaparin
n=23 participants at risk
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.
Enoxaparin
|
B: Weight Adjusted Enoxaparin
n=24 participants at risk
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.
Enoxaparin
|
|---|---|---|
|
Infections and infestations
Skin Infections
|
4.3%
1/23 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/24 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/23 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
4.2%
1/24 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Investigations
Platelets Count Decrease
|
0.00%
0/23 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
4.2%
1/24 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/24 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/24 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
1/23 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/24 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Vascular disorders
Distal deep vein thrombosis
|
8.7%
2/23 • Number of events 2 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/24 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
General disorders
Fatigue
|
0.00%
0/23 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
4.2%
1/24 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
General disorders
Pain
|
0.00%
0/23 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
4.2%
1/24 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - extremeties
|
0.00%
0/23 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
4.2%
1/24 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/23 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
4.2%
1/24 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Cardiac disorders
Atrial Fibrillation
|
4.3%
1/23 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/24 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Investigations
Neutrophil Count Decrease
|
4.3%
1/23 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/24 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
4.3%
1/23 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/24 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
|
Gastrointestinal disorders
GI-Hemorrhage
|
4.3%
1/23 • Number of events 1 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
0.00%
0/24 • All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
|
Additional Information
Jeffrey Zwicker, Division of Thrombosis and Haemostasis, Division of Hematology and Oncology
Beth Israel Deaconess Medical Center, Harvard Medical School
Phone: 617.667.9299
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place