Comparing Anti-XA Levels in Post-Cesarean Patients Undergoing Enoxaparin Thromboprophylaxis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by MemorialCare Health System
Sponsor:
Information provided by (Responsible Party):
MemorialCare Health System
ClinicalTrials.gov Identifier:
NCT02070237
First received: February 20, 2014
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Obesity
Obesity, Morbid
Pregnancy
Complications; Cesarean Section
Venous Thromboembolism
Postpartum Deep Phlebothrombosis
Pulmonary Embolism
Drug: Enoxaparin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by MemorialCare Health System:

Primary Outcome Measures:
  • Anti Xa level [ Time Frame: 3.5-4 hours after the third dose of Lovenox (enoxaparin) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Anti Xa [ Time Frame: 3.5-4 hours after the third dose of Lovenox (enoxaparin) ] [ Designated as safety issue: No ]
    We will assess if any of the subjects has an Anti Xa level that is in the supraprophylactic range (treatment range).


Estimated Enrollment: 90
Study Start Date: August 2013
Estimated Study Completion Date: March 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enoxaparin Once Daily
This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once 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.
Other Name: Lovenox
Active Comparator: Enoxaparin Twice Daily
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.
Other Name: Lovenox

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070237

Contacts
Contact: Megan L Stephenson, MD 562-933-2730 meganls@uci.edu
Contact: Deysi Caballero, LVN 562-933-2732 DCaballero@memorialcare.org

Locations
United States, California
Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital Recruiting
Long Beach, California, United States, 90806
Contact: Jennifer McNulty, MD    562-933-2730    JMcNulty@memorialcare.org   
Contact: Deysi Caballero, LVN    562-933-2732    DCaballero@memorialcare.org   
Sub-Investigator: Megan L Stephenson, MD         
Principal Investigator: Jennifer McNulty, MD         
Sponsors and Collaborators
MemorialCare Health System
Investigators
Principal Investigator: Jennifer McNulty, MD Memorial Care Health System
Principal Investigator: Megan L Stephenson, MD Memorial Health Care System; University of California Irvine
  More Information

No publications provided

Responsible Party: MemorialCare Health System
ClinicalTrials.gov Identifier: NCT02070237     History of Changes
Other Study ID Numbers: 159-12
Study First Received: February 20, 2014
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by MemorialCare Health System:
Obesity
Obesity, Morbid
Pregnancy
Cesarean
Venous thromboembolism
Deep venous thrombosis
Pulmonary embolism

Additional relevant MeSH terms:
Embolism
Obesity
Obesity, Morbid
Pulmonary Embolism
Thromboembolism
Venous Thrombosis
Thrombophlebitis
Puerperal Disorders
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Thrombosis
Phlebitis
Peripheral Vascular Diseases
Vasculitis
Pregnancy Complications
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents

ClinicalTrials.gov processed this record on July 24, 2014