ObesityNCT01587781
Prophylactic Use of Enoxaparin in Morbidly Obese Adolescents During Bariatric Surgery
An observational study of Obesity, run by Janelle Vaughns at 1 site in United States.
Trial summary
This study is about a drug called enoxaparin which is used to prevent or treat blood clots. There are no studies about the use of this drug in obese adolescents and yet the investigators use it to prevent clots when they have surgery at Children's National for weight loss. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Obesity
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A total of 12 patients will be enrolled. The population for this study will include both male and female adolescent patients from all ethnic backgrounds with BMI greater than or equal to 95 percentile. Each patient will receive enoxaparin SC q 12 hours. The blood samples for the study would be taken prior to the second dose.
Who may be able to join
- The research participant will be a Children's National Medical Center (CNMC) patient admitted for bariatric surgery.
- The age ranges will be between 12 and 20.
- All racial and ethnic groups will be included.
- The Body Mass Index (BMI) will be calculated using height and weight and will include greater than or equal to 95th percentile. At our bariatric center the minimum BMI is 35 to qualify for surgical intervention for weight loss. In other words, all patients having bariatric surgery will be eligible for inclusion.
- Informed consent and assent will be obtained prior to each investigation from the patients' parents and when legally appropriate from the patient.
Who cannot join
- This is a non-interventional study and patients would be routinely screened for history of bleeding disorders or at risk of bleeding as a part of standard complete history and exam. As a standard, patients receiving platelet inhibitors including acetylsalicylic acid, salicylates, Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone would be closely monitored.
- Any patient with prior dosing with enoxaparin or any other anticoagulant within the past 24 hours would be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
This study is about a drug called enoxaparin which is used to prevent or treat blood clots. There are no studies about the use of this drug in obese adolescents and yet the investigators use it to prevent clots when they have surgery at Children's National for weight loss. The investigators hypothesis is that the obesity leads to increased kidney size and faster drug clearance. Therefore the investigators think they might be underdosing these adolescents. This study will check the drug levels at different points after the drug dose to see whether the investigators are achieving the expected levels for prevention of clots.
Read the detailed description
Enoxaparin is the drug of choice for prevention and treatment of venous thromboembolism (VTE) in children and adults. A major concern with any antithrombotic therapy is an increased risk of hemorrhage. There are not many concrete data published for enoxaparin use in children and adolescents, and absolutely no guidance is available for (morbidly) obese children and adolescents as they are not included in clinical trials during the clinical phases of drug development. Physicians often find themselves puzzled when selecting a dose for obese children. This study aims to find the optimal way to dose enoxaparin in (morbidly) obese children and adolescents that will result in a safe and effective use of this drug as prophylaxis during bariatric surgery.
The optimum therapeutic/preventive dose of a drug depends on its pharmacokinetic and pharmacodynamic properties. Both these processes can be affected by body composition and the physiological changes that occur in obese children. Obesity not only increases the total fat amount, but also the lean body mass. However, the percentage of fat tissue increases more than the lean body mass. Obesity as a disease state is also associated with changes in plasma protein constituents, decreases in tissue perfusion; and increases in adipose tissue mass, lean body mass, cardiac output, and splanchnic blood flow, as compared with normal-weight individuals.
High BMI is believed be an independent risk factor for VTE. Therefore, obese adolescents are also being prescribed prophylactic doses of enoxaparin in situations where there is risk of VTE. The 2008 recommended guidelines by the American College of Chest Physicians does not mention any type of dosing considerations of anticoagulants in obese children. However, it states that higher than usual doses be used in adult patients undergoing bariatric surgery. The use of enoxaparin is not approved for children but is being used widely for the prophylaxis and treatment of VTE in a wide variety of settings in children of all age groups. There are very limited number of studies that involve enoxaparin use in children. Out of these most of the data are available for the use of enoxaparin for the treatment of VTE and not prophylaxis of VTE.
Studies have shown several age related physiologic differences between pediatric and adult patients. Neonates exhibit an accelerated clearance rate and a larger volume of distribution as compared with adults. Children treated for malignancy required higher doses compared to adults. Pharmacokinetic/pharmacodynamic studies that have included children do not provide specific data on different age groups. Further more, the sample size is very small and mostly involve patients that were treated for VTE or thrombophilia. There is no information specifying dosing for prophylactic therapy.
- Conditions
- Obesity
- Keywords
- Pharmacokinetics of enoxaparin
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
To find the optimal way to dose enoxaparin in (morbidly) obese children and adolescents after the use of this drug as prophylaxis during bariatric surgery
This study is non-interventional and the potential risks associated with the "study" are none. Enoxaparin will be administered as standard of care.
Measured: In our study participants, Factor-X a level will be measured at times: 0, 1, 2, 4, 6, and 12 hr respectively. The first IV will be placed with the patient awake and the first sample of 3 ml for factor X-a (time point 0) will occur after its placement but
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janelle Vaughns
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Janelle Vaughns, Children's National Research Institute
- Investigators
- Janelle Vaughns, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587781
- Sponsor's protocol ID
- 1824
- Status last verified
- Mar 2022
- First submitted
- 26 Apr 2012
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mushtaq A, Vaughns JD, Ziesenitz VC, Nadler EP, van den Anker JN. Use of Enoxaparin in Obese Adolescents During Bariatric Surgery--a Pilot Study. Obes Surg. 2015 Oct;25(10):1869-74. doi: 10.1007/s11695-015-1630-x.
PubMed 25716128
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Enoxaparin in Morbidly Obese Adolescents During Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01587781
- Acronym / sponsor ID
- 1824
- Conditions
- Obesity
- Keywords
- Pharmacokinetics of enoxaparin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Janelle VaughnsUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is about a drug called enoxaparin which is used to prevent or treat blood clots. There are no studies about the use of this drug in obese adolescents and yet the investigators use it to prevent clots when they have surgery at Children's National for weight loss. The investigators hypothesis is that the obesity leads to increased kidney size and faster drug clearance. Therefore the investigators think they might be underdosing these adolescents. This study will check the drug levels at different points after the drug dose to see whether the investigators are achieving the expected levels for prevention of clots.
Detailed description
Enoxaparin is the drug of choice for prevention and treatment of venous thromboembolism (VTE) in children and adults. A major concern with any antithrombotic therapy is an increased risk of hemorrhage. There are not many concrete data published for enoxaparin use in children and adolescents, and absolutely no guidance is available for (morbidly) obese children and adolescents as they are not included in clinical trials during the clinical phases of drug development. Physicians often find themselves puzzled when selecting a dose for obese children. This study aims to find the optimal way to dose enoxaparin in (morbidly) obese children and adolescents that will result in a safe and effective use of this drug as prophylaxis during bariatric surgery.
The optimum therapeutic/preventive dose of a drug depends on its pharmacokinetic and pharmacodynamic properties. Both these processes can be affected by body composition and the physiological changes that occur in obese children. Obesity not only increases the total fat amount, but also the lean body mass. However, the percentage of fat tissue increases more than the lean body mass. Obesity as a disease state is also associated with changes in plasma protein constituents, decreases in tissue perfusion; and increases in adipose tissue mass, lean body mass, cardiac output, and splanchnic blood flow, as compared with normal-weight individuals.
High BMI is believed be an independent risk factor for VTE. Therefore, obese adolescents are also being prescribed prophylactic doses of enoxaparin in situations where there is risk of VTE. The 2008 recommended guidelines by the American College of Chest Physicians does not mention any type of dosing considerations of anticoagulants in obese children. However, it states that higher than usual doses be used in adult patients undergoing bariatric surgery. The use of enoxaparin is not approved for children but is being used widely for the prophylaxis and treatment of VTE in a wide variety of settings in children of all age groups. There are very limited number of studies that involve enoxaparin use in children. Out of these most of the data are available for the use of enoxaparin for the treatment of VTE and not prophylaxis of VTE.
Studies have shown several age related physiologic differences between pediatric and adult patients. Neonates exhibit an accelerated clearance rate and a larger volume of distribution as compared with adults. Children treated for malignancy required higher doses compared to adults. Pharmacokinetic/pharmacodynamic studies that have included children do not provide specific data on different age groups. Further more, the sample size is very small and mostly involve patients that were treated for VTE or thrombophilia. There is no information specifying dosing for prophylactic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A total of 12 patients will be enrolled. The population for this study will include both male and female adolescent patients from all ethnic backgrounds with BMI greater than or equal to 95 percentile. Each patient will receive enoxaparin SC q 12 hours. The blood samples for the study would be taken prior to the second dose.
Key inclusion criteria (5 listed)
- The research participant will be a Children's National Medical Center (CNMC) patient admitted for bariatric surgery.
- The age ranges will be between 12 and 20.
- All racial and ethnic groups will be included.
- The Body Mass Index (BMI) will be calculated using height and weight and will include greater than or equal to 95th percentile. At our bariatric center the minimum BMI is 35 to qualify for surgical intervention for weight loss. In other words, all patients having bariatric surgery will be eligible for inclusion.
- Informed consent and assent will be obtained prior to each investigation from the patients' parents and when legally appropriate from the patient.
Key exclusion criteria (2 listed)
- This is a non-interventional study and patients would be routinely screened for history of bleeding disorders or at risk of bleeding as a part of standard complete history and exam. As a standard, patients receiving platelet inhibitors including acetylsalicylic acid, salicylates, Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone would be closely monitored.
- Any patient with prior dosing with enoxaparin or any other anticoagulant within the past 24 hours would be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To find the optimal way to dose enoxaparin in (morbidly) obese children and adolescents after the use of this drug as prophylaxis during bariatric surgery
Time frame: In our study participants, Factor-X a level will be measured at times: 0, 1, 2, 4, 6, and 12 hr respectively. The first IV will be placed with the patient awake and the first sample of 3 ml for factor X-a (time point 0) will occur after its placement but
This study is non-interventional and the potential risks associated with the "study" are none. Enoxaparin will be administered as standard of care.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Results publication: PubMed 25716128Mushtaq A, Vaughns JD, Ziesenitz VC, Nadler EP, van den Anker JN. Use of Enoxaparin in Obese Adolescents During Bariatric Surgery--a Pilot Study. Obes Surg. 2015 Oct;25(10):1869-74. doi: 10.1007/s11695-015-1630-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janelle Vaughns, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Janelle Vaughns at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find the optimal way to dose enoxaparin in (morbidly) obese children and adolescents after the use of this drug as prophylaxis during bariatric surgery (time frame: In our study participants, Factor-X a level will be measured at times: 0, 1, 2, 4, 6, and 12 hr respectively. The first IV will be placed with the patient awake and the first sample of 3 ml for factor X-a (time point 0) will occur after its placement but). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01587781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.