Trial Outcomes & Findings for Enoxaparin Dosing in Obesity (NCT NCT01798550)

NCT ID: NCT01798550

Last Updated: 2017-12-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 62 participants
• Primary outcome timeframe: 3-5 hours after at least 3rd dose
• Results posted on: 2017-12-14

Participant Flow

Participant milestones

Measure	Reduced Dose (0.8 mg/kg) Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Standard Dose (1 mg/kg) Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Overall Study STARTED	30	32
Overall Study COMPLETED	28	26
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enoxaparin Dosing in Obesity

Baseline characteristics by cohort

Measure	Reduced Dose (0.8 mg/kg) n=30 Participants Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Standard Dose (1 mg/kg) n=32 Participants Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Total n=62 Participants Total of all reporting groups
Age, Continuous	55 years n=5 Participants	56 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3-5 hours after at least 3rd dose

Outcome measures

Measure	Reduced Dose (0.8 mg/kg) n=28 Participants Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Standard Dose (1 mg/kg) n=26 Participants Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group	25 Participants	20 Participants

SECONDARY outcome

Timeframe: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days

Time to therapeutic Anti-Xa = time in hours from enoxaparin dose #1 to the first therapeutic Anti-Xa. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.

Outcome measures

Measure	Reduced Dose (0.8 mg/kg) n=28 Participants Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Standard Dose (1 mg/kg) n=26 Participants Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Time to Therapeutic Anti-Xa Level for Both Groups	28.6 hours Interval 26.7 to 41.0	31.9 hours Interval 27.7 to 39.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days

The goal anti-Xa peak level range was defined as 0.5 - 1.1 International units/mL. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.

Outcome measures

Measure	Reduced Dose (0.8 mg/kg) n=28 Participants Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Standard Dose (1 mg/kg) n=26 Participants Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Median Steady State Anti-Xa Levels	0.8 IU/mL Interval 0.66 to 0.9	0.86 IU/mL Interval 0.69 to 1.01

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days

Outcome measures

Measure	Reduced Dose (0.8 mg/kg) n=28 Participants Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Standard Dose (1 mg/kg) n=26 Participants Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level	3 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days

Outcome measures

Measure	Reduced Dose (0.8 mg/kg) n=28 Participants Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing	Standard Dose (1 mg/kg) n=26 Participants Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing
Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level	0 Participants	0 Participants

Adverse Events

Reduced Dose (0.8 mg/kg)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Dose (1 mg/kg)

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

Christine Kempton MD, MSc

Emory University

Phone: 404-778-1900

Email: ckempto@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place