A Phase 1 interventional study of Enoxaparin in Obesity, Obesity, Morbid and Pregnancy, sponsored by MemorialCare Health System. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-23.
Sponsored by MemorialCare Health System · Phase 1, Interventional, and Prevention
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).
This is a multi-center, prospective, randomized controlled study to compare the proportion of patients that achieve the desired effect of LMWH (enoxaparin) thromboprophylaxis as measured by peak anti Xa level with weight based twice daily dosing versus standard fixed daily dosing. The investigators hypothesize that when enoxaparin is dosed by maternal weight and administered twice daily, the anti-factor Xa level would more frequently achieve prophylactic levels when compared to taking a fixed 40 mg of the drug daily.
Subjects will be women with a BMI > 35 who have undergone a cesarean delivery and who will receive thromboprophylaxis with enoxaparin (Lovenox) at the judgment of their physician.
Women who are eligible and consent to participate in the study will be randomized in a 1:1 ratio to one of the following groups:
Group 1 will receive the weight based dosing (0.5mg/kg BID) enoxaparin (Lovenox®; Aventis Pharmaceuticals) regimen Group 2 will received the fixed dose (40mg daily) enoxaparin (Lovenox®; Aventis Pharmaceuticals) regimen.
Treatment will begin between 8 and 12 hours post operatively and this regimen will continue until discharge from the hospital, usually on the third or fourth day after surgery. A single peak anti Xa level will be drawn 3.5-4 hours after the third dose of medication. The results of the anti Xa level will only be for research purposes and will not guide clinical management.
The primary outcome for this study is to assess the peak anti-factor Xa level in the blood, and whether or not the subject achieved the desired prophylactic level when receiving fixed dose of enoxaparin compared with weight based dosing.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 90 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →MemorialCare Health System is the lead sponsor of 21 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.
Drug: Enoxaparin
This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.
Drug: Enoxaparin
Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.
Also known as: Lovenox
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.
Time frame: 3.5-4 hours after the third dose of Lovenox (enoxaparin)
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).
Time frame: 3.5-4 hours after the third dose of Lovenox (enoxaparin)
| Milestone | Enoxaparin Once Daily | Enoxaparin Twice Daily |
|---|---|---|
| Started | 45 | 45 |
| Completed | 42 | 42 |
| Not completed | 3 | 3 |
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.
| IU/mL | Enoxaparin Once Daily | Enoxaparin Twice Daily |
|---|---|---|
| Anti Xa Level | 0.14 (0.12 to 0.16) | 0.30 (0.27 to 0.31) |
We will assess if any of the subjects has an Anti Xa level that is in the supraprophylactic range (treatment range).
| participants | Enoxaparin Once Daily | Enoxaparin Twice Daily |
|---|---|---|
| Supraprophylactic Range Anti Xa Level | 0 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enoxaparin Once Daily | — | 0/42 (0%) | 0/42 (0%) |
| Enoxaparin Twice Daily | — | 0/42 (0%) | 0/42 (0%) |
| Age, Categorical(Participants) | Enoxaparin Once Daily | Enoxaparin Twice Daily | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 45 | 90 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Enoxaparin Once Daily | Enoxaparin Twice Daily | Total |
|---|---|---|---|
| Mean | 33 ± 6.6 | 30 ± 5.4 | 32 ± 6.8 |
| Sex: Female, Male(Participants) | Enoxaparin Once Daily | Enoxaparin Twice Daily | Total |
|---|---|---|---|
| Female | 45 | 45 | 90 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Enoxaparin Once Daily | Enoxaparin Twice Daily | Total |
|---|---|---|---|
| United States | 45 | 45 | 90 |
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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