Trial Outcomes & Findings for A Different Approach to Preventing Thrombosis (NCT NCT02774265)
NCT ID: NCT02774265
Last Updated: 2022-01-05
Results Overview
Includes a greater than 2g/dL drop in hemoglobin, blood transfusion, hematoma evacuation, re-operation for a deep surgical site infection or minor procedure for bleeding and GI bleed
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
329 participants
Primary outcome timeframe
90 days
Results posted on
2022-01-05
Participant Flow
We recruited inpatients admitted between January 19, 2016 and November 1, 2016.
Participant milestones
| Measure |
VTE Prophylaxis With Enoxaparin 30mg BID
The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.
VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
|
VTE Prophylaxis With Aspirin 81mg BID
The group receiving VTE prophylaxis with ASA 81mg PO BID
VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
165
|
|
Overall Study
COMPLETED
|
151
|
159
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Different Approach to Preventing Thrombosis
Baseline characteristics by cohort
| Measure |
VTE Prophylaxis With Enoxaparin 30mg BID
n=164 Participants
The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.
VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
|
VTE Prophylaxis With Aspirin 81mg BID
n=165 Participants
The group receiving VTE prophylaxis with ASA 81mg PO BID
VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
|
Total
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 20.4 • n=99 Participants
|
48 years
STANDARD_DEVIATION 18.6 • n=107 Participants
|
46.7 years
STANDARD_DEVIATION 19.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
223 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
53 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
203 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Current smoker
|
62 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: As described in Participant Flow
Includes a greater than 2g/dL drop in hemoglobin, blood transfusion, hematoma evacuation, re-operation for a deep surgical site infection or minor procedure for bleeding and GI bleed
Outcome measures
| Measure |
VTE Prophylaxis With Enoxaparin 30mg BID
n=164 Participants
The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.
VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
|
VTE Prophylaxis With Aspirin 81mg BID
n=165 Participants
The group receiving VTE prophylaxis with ASA 81mg PO BID
VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
|
|---|---|---|
|
Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication.
|
52 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: same as flow chart
DVT and how the diagnosis was made will be recorded. The number of events in participants in each arm will be compared to evaluate efficacy.
Outcome measures
| Measure |
VTE Prophylaxis With Enoxaparin 30mg BID
n=164 Participants
The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.
VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
|
VTE Prophylaxis With Aspirin 81mg BID
n=165 Participants
The group receiving VTE prophylaxis with ASA 81mg PO BID
VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
|
|---|---|---|
|
Number of Participants With Deep Venous Thromboembolism
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: As per flow sheet
Bases on imaging obtained for symptoms.
Outcome measures
| Measure |
VTE Prophylaxis With Enoxaparin 30mg BID
n=164 Participants
The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.
VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
|
VTE Prophylaxis With Aspirin 81mg BID
n=165 Participants
The group receiving VTE prophylaxis with ASA 81mg PO BID
VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
|
|---|---|---|
|
Number of Participants With Pulmonary Embolism Events
|
6 Participants
|
2 Participants
|
Adverse Events
VTE Prophylaxis With Enoxaparin 30mg BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
VTE Prophylaxis With Aspirin 81mg BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place