Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Dose (0.8 mg/kg) | Experimental | Enoxaparin 0.8 mg/kg (using total body weight) twice daily |
|
| Standard Dose (1 mg/kg) | Active Comparator | Enoxaparin 1 mg/kg (using total body weight) twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | Twice daily dosing |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christine L Kempton, MD, MSc | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Dose (0.8 mg/kg) | Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing |
| FG001 | Standard Dose (1 mg/kg) | Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Reduced Dose (0.8 mg/kg) | Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing |
| BG001 | Standard Dose (1 mg/kg) | Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group | Posted | Count of Participants | Participants | 3-5 hours after at least 3rd dose |
|
|
3 years, duration of the study
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduced Dose (0.8 mg/kg) | Enoxaparin 0.8 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Kempton MD, MSc | Emory University | 404-778-1900 | ckempto@emory.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2012 | Nov 15, 2017 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days |
| Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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. | Posted | Median | Inter-Quartile Range | hours | Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | IU/mL | Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days |
|
|
|
| Other Pre-specified | Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level | Posted | Count of Participants | Participants | Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days |
|
|
|
| Other Pre-specified | Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level | Posted | Count of Participants | Participants | Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Standard Dose (1 mg/kg) | Enoxaparin 1 mg/kg (using total body weight) twice daily Enoxaparin: Twice daily dosing | 0 | 32 | 0 | 32 | 0 | 32 |
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |