Obesity Clinical Trial
Official title:
Comparing Anti-XA Levels in Post-Cesarean Patients With BMI >35 Undergoing Enoxaparin Thromboprophylaxis With Weight Based Dosing Twice Daily Versus Fixed Dose 40 Milligrams Daily
Verified date | January 2015 |
Source | MemorialCare Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Pregnant and recently postpartum women are at significantly higher risk of developing a
blood clot in their arms or legs known as a deep venous thrombosis (DVT) and/or a blood clot
in their lungs known as a pulmonary embolism (PE) compared to their non pregnant
counterparts. It is estimated that this risk increases anywhere from 4 to 50 times higher in
pregnant versus non-pregnant women and further increases almost 11 fold in the post partum
period. This risk is almost doubled when the patient undergoes cesarean delivery. In 2011,
the American College of Obstetricians and Gynecologists (ACOG) issued updated guidelines
stating that for patients undergoing cesarean delivery with additional risk factors for clot
or thromboembolism, protective (prophylactic) treatment with low molecular weight heparin
(LMWH) a type of blood thinner should be considered. However, no specific guidelines about
which risk factors should be considered, or what medication doses should be used were
provided. The American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice
Guidelines published in 2012 delineated who should be given prophylaxis based on various
risk factors, however acknowledged that the recommendations were based on weak quality
evidence.
ACOG endorses either once or twice a day dosing for high risk patients after delivery and
states that adjustments for obese women should be made on a case by case basis. However,
there are limited studies on the dosing of LMWH in specific subpopulations including post
operative patients, pregnant patients and obese patients. All of these studies have urged
further investigation of the correct dosing for these high risk subjects due to changes
associated with pregnancy and the level of medication in the blood that may put these
patients at higher risk of venous thromboembolism. Many previous studies have shown that
women in these high risk categories do not achieve protective levels of the medication
measured with a laboratory test; anti Xa level. The investigators hypothesize that due to
their dual risk, obese post-operative recently pregnant women may not be adequately
protected with the daily fixed dose and might need more frequent dosing to protect them.
The objective of this study is to assess what proportion of women achieve the desired anti
Xa level with the fixed daily dose versus twice daily weight based dosing (0.5 mg/kg).
Status | Completed |
Enrollment | 90 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women with a body mass index >35 who have undergone cesarean delivery in the last 12 hours who will receive thromboprophylaxis with enoxaparin - Subjects who consent to the study. Exclusion Criteria: - Women with a previous history of deep venous thrombosis or pulmonary embolism - Women who are currently receiving another form of low molecular weight heparin or unfractionated heparin. - Women who are receiving other concomitant anticoagulant medications, such as warfarin, lepirudin, or argatroban. - Subjects who are unable or unwilling to give informed consent. - Women who, in the judgment of the investigators, would not be in the best interest of the patient to participate in the study. - Allergy to enoxaparin. - Women with renal impairment - Women with contraindications to Lovenox treatment such as women with active bleeding or thrombocytopenia |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital | Long Beach | California |
Lead Sponsor | Collaborator |
---|---|
MemorialCare Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti Xa Level | 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. | 3.5-4 hours after the third dose of Lovenox (enoxaparin) | No |
Secondary | Supraprophylactic Range Anti Xa Level | We will assess if any of the subjects has an Anti Xa level that is in the supraprophylactic range (treatment range). | 3.5-4 hours after the third dose of Lovenox (enoxaparin) | No |
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