Trial Outcomes & Findings for Comparing Anti-XA Levels in Post-Cesarean Patients Undergoing Enoxaparin Thromboprophylaxis (NCT NCT02070237)
NCT ID: NCT02070237
Last Updated: 2015-11-23
Results Overview
Our primary outcome will be to assess the Anti Xa level drawn 3.5-4 hours after the third dose of Lovenox (enoxaparin) to assess if this is in the prophylactic range.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
90 participants
Primary outcome timeframe
3.5-4 hours after the third dose of Lovenox (enoxaparin)
Results posted on
2015-11-23
Participant Flow
Participant milestones
| Measure |
Enoxaparin Once Daily
This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.
|
Enoxaparin Twice Daily
This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
42
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Anti-XA Levels in Post-Cesarean Patients Undergoing Enoxaparin Thromboprophylaxis
Baseline characteristics by cohort
| Measure |
Enoxaparin Once Daily
n=45 Participants
This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.
|
Enoxaparin Twice Daily
n=45 Participants
This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
30 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
32 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3.5-4 hours after the third dose of Lovenox (enoxaparin)Our primary outcome will be to assess the Anti Xa level drawn 3.5-4 hours after the third dose of Lovenox (enoxaparin) to assess if this is in the prophylactic range.
Outcome measures
| Measure |
Enoxaparin Once Daily
n=42 Participants
This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.
|
Enoxaparin Twice Daily
n=42 Participants
This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.
|
|---|---|---|
|
Anti Xa Level
|
0.14 IU/mL
Interval 0.12 to 0.16
|
0.30 IU/mL
Interval 0.27 to 0.31
|
SECONDARY outcome
Timeframe: 3.5-4 hours after the third dose of Lovenox (enoxaparin)We will assess if any of the subjects has an Anti Xa level that is in the supraprophylactic range (treatment range).
Outcome measures
| Measure |
Enoxaparin Once Daily
n=42 Participants
This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.
|
Enoxaparin Twice Daily
n=42 Participants
This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.
Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.
|
|---|---|---|
|
Supraprophylactic Range Anti Xa Level
|
0 participants
|
0 participants
|
Adverse Events
Enoxaparin Once Daily
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enoxaparin Twice Daily
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