Obesity
Conditions
Keywords
Enoxaparin dosing, Obesity
Brief summary
The purpose of this study is to determine an effective enoxaparin dosing strategy in medically ill, morbidly obese patients. This study will include adult patients greater than 18 yrs of age being admitted to Grady Hospital in Atlanta, GA. Potentially vulnerable patients such as prisoners, children, and pregnant women will not be enrolled in the study. Study participants will be contacted in person by the study personnel once inclusion criteria are met. Written informed consent will be obtained in person while hospitalized. Once the patient is consented they will be given enoxaparin and blood samples will be drawn. The data collected will be from the electronic medical record which is accessed only with a username and password so it is not publicly available. The data will be identifiable upon collection and will be kept on a password protected file on a computer in a locked office. The data will be de-identified after data analysis and only the study personnel will have access to the code that links identifiers to subjects. A HIPAA waiver will be requested to access existing data in order to identify patients for enrollment. All data will be collected in an office in the hospital. The study participants' burden will be minimal and dependent only on time of consent process since morbidly obese patients would be receiving this blood sample collection regardless of their participation in the study.
Interventions
DRUGEnoxaparin
Twice daily dosing
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned treating with twice daily enoxaparin * BMI \>= 40 kg/m2
Exclusion criteria
* \< 18 years of age * CrCl \< 30 ml/min * Pregnancy * Prisoner * Active bleeding * Already received 3 consecutive doses of enoxaparin * Use of therapeutic enoxaparin for more than 5 consecutive days within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group | 3-5 hours after at least 3rd dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Therapeutic Anti-Xa Level for Both Groups | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Median Steady State Anti-Xa Levels | 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. |
| Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level | Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days | — |
| Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level | Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reduced Dose (0.8 mg/kg) Enoxaparin 0.8 mg/kg (using total body weight) twice daily
Enoxaparin: Twice daily dosing | 30 |
| Standard Dose (1 mg/kg) Enoxaparin 1 mg/kg (using total body weight) twice daily
Enoxaparin: Twice daily dosing | 32 |
| Total | 62 |
Baseline characteristics
| Characteristic | Reduced Dose (0.8 mg/kg) | Total | Standard Dose (1 mg/kg) |
|---|---|---|---|
| Age, Continuous | 55 years | 56 years | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 54 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 8 Participants | 5 Participants |
| Region of Enrollment United States | 30 Participants | 62 Participants | 32 Participants |
| Sex: Female, Male Female | 12 Participants | 30 Participants | 18 Participants |
| Sex: Female, Male Male | 18 Participants | 32 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 32 |
| other Total, other adverse events | 0 / 30 | 0 / 32 |
| serious Total, serious adverse events | 0 / 30 | 0 / 32 |
Outcome results
Primary
Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group
Time frame: 3-5 hours after at least 3rd dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reduced Dose (0.8 mg/kg) | Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group | 25 Participants |
| Standard Dose (1 mg/kg) | Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group | 20 Participants |
Secondary
Time to Therapeutic Anti-Xa Level for Both Groups
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.
Time frame: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reduced Dose (0.8 mg/kg) | Time to Therapeutic Anti-Xa Level for Both Groups | 28.6 hours |
| Standard Dose (1 mg/kg) | Time to Therapeutic Anti-Xa Level for Both Groups | 31.9 hours |
Other Pre-specified
Median Steady State Anti-Xa Levels
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.
Time frame: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reduced Dose (0.8 mg/kg) | Median Steady State Anti-Xa Levels | 0.8 IU/mL |
| Standard Dose (1 mg/kg) | Median Steady State Anti-Xa Levels | 0.86 IU/mL |
Other Pre-specified
Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level
Time frame: Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reduced Dose (0.8 mg/kg) | Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level | 3 Participants |
| Standard Dose (1 mg/kg) | Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level | 6 Participants |
Other Pre-specified
Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level
Time frame: Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reduced Dose (0.8 mg/kg) | Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level | 0 Participants |
| Standard Dose (1 mg/kg) | Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level | 0 Participants |