Trial Outcomes & Findings for Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery (NCT NCT03212365)
NCT ID: NCT03212365
Last Updated: 2020-09-16
Results Overview
Avoidance of under-anticoagulation (peak aFXa \<0.2 IU/mL)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
295 participants
Primary outcome timeframe
Four hours following third enoxaparin dose
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Fixed Dose
Participants will receive 40 mg enoxaparin twice daily
Fixed dose: Participants will receive 40 mg enoxaparin twice daily
|
Variable Dose
Participants will receive 0.5mg/kg enoxaparin twice daily
Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
144
|
|
Overall Study
COMPLETED
|
128
|
130
|
|
Overall Study
NOT COMPLETED
|
23
|
14
|
Reasons for withdrawal
| Measure |
Fixed Dose
Participants will receive 40 mg enoxaparin twice daily
Fixed dose: Participants will receive 40 mg enoxaparin twice daily
|
Variable Dose
Participants will receive 0.5mg/kg enoxaparin twice daily
Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily
|
|---|---|---|
|
Overall Study
Discharged prior to Xa level
|
12
|
8
|
|
Overall Study
Bled requiring enoxaparin cessation
|
4
|
2
|
|
Overall Study
Refused study medication
|
3
|
0
|
|
Overall Study
Initiated heparin infusion on floor
|
1
|
1
|
|
Overall Study
Unexpected return to OR
|
1
|
1
|
|
Overall Study
Medication distribution error
|
1
|
0
|
|
Overall Study
Required epidural placement
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
developed acute renal failure
|
0
|
1
|
Baseline Characteristics
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
Baseline characteristics by cohort
| Measure |
Fixed Dose
n=151 Participants
Participants will receive 40 mg enoxaparin twice daily
Fixed dose: Participants will receive 40 mg enoxaparin twice daily
|
Variable Dose
n=144 Participants
Participants will receive 0.5mg/kg enoxaparin twice daily
Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
50.8 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
81 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
70 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
137 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American/Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
151 participants
n=5 Participants
|
144 participants
n=7 Participants
|
295 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Four hours following third enoxaparin doseAvoidance of under-anticoagulation (peak aFXa \<0.2 IU/mL)
Outcome measures
| Measure |
Fixed Dose
n=128 Participants
Participants will receive 40 mg enoxaparin twice daily
Fixed dose: Participants will receive 40 mg enoxaparin twice daily
|
Variable Dose
n=130 Participants
Participants will receive 0.5mg/kg enoxaparin twice daily
Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily
|
|---|---|---|
|
Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL)
|
76.6 percentage of participants
|
79.9 percentage of participants
|
PRIMARY outcome
Timeframe: Four hours following third enoxaparin doseAvoidance of over-anticoagulation (peak aFXa \>0.4 IU/mL)
Outcome measures
| Measure |
Fixed Dose
n=128 Participants
Participants will receive 40 mg enoxaparin twice daily
Fixed dose: Participants will receive 40 mg enoxaparin twice daily
|
Variable Dose
n=130 Participants
Participants will receive 0.5mg/kg enoxaparin twice daily
Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily
|
|---|---|---|
|
Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL)
|
82.2 percentage of participants
|
90.6 percentage of participants
|
SECONDARY outcome
Timeframe: 90 daysAny symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery
Outcome measures
| Measure |
Fixed Dose
n=151 Participants
Participants will receive 40 mg enoxaparin twice daily
Fixed dose: Participants will receive 40 mg enoxaparin twice daily
|
Variable Dose
n=144 Participants
Participants will receive 0.5mg/kg enoxaparin twice daily
Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily
|
|---|---|---|
|
Percentage of Participants With Venous Thromboembolism Events
|
0.66 percentage of patients
|
0.69 percentage of patients
|
SECONDARY outcome
Timeframe: 90 daysBleeding events requiring alteration in the course of care within 90 days of surgery
Outcome measures
| Measure |
Fixed Dose
n=151 Participants
Participants will receive 40 mg enoxaparin twice daily
Fixed dose: Participants will receive 40 mg enoxaparin twice daily
|
Variable Dose
n=144 Participants
Participants will receive 0.5mg/kg enoxaparin twice daily
Variable dose: Participants will receive 0.5mg/kg enoxaparin twice daily
|
|---|---|---|
|
Percentage of Patients With Bleeding Events
|
6.0 percentage of patients
|
8.3 percentage of patients
|
Adverse Events
Fixed Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Variable Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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