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

NCT02070237 | Completed Phase 1 Results

• 1 other identifier: 159-12
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obesity; Obesity, Morbid; Pregnancy; Complications; Cesarean Section; Venous Thromboembolism; Postpartum Deep Phlebothrombosis; Pulmonary Embolism

Keywords

Obesity; Obesity, Morbid; Pregnancy; Cesarean; Venous thromboembolism; Deep venous thrombosis; Pulmonary embolism

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Supraprophylactic Range Anti Xa Level

  3.5-4 hours after the third dose of Lovenox (enoxaparin)

Study Arms (2)

Enoxaparin Once Daily

ACTIVE COMPARATOR

This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.

Drug: Enoxaparin

Enoxaparin Twice Daily

ACTIVE COMPARATOR

This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.

Drug: Enoxaparin

Interventions

Enoxaparin DRUG

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

Enoxaparin Once Daily; Enoxaparin Twice Daily

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MemorialCare Health System: lead

Study Sites (1)

Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital

Long Beach, California, 90806, United States

Location

Related Publications (2)

• Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.

  PMID: 33779986 DERIVED

• Stephenson ML, Serra AE, Neeper JM, Caballero DC, McNulty J. A randomized controlled trial of differing doses of postcesarean enoxaparin thromboprophylaxis in obese women. J Perinatol. 2016 Feb;36(2):95-9. doi: 10.1038/jp.2015.130. Epub 2015 Dec 10.

  PMID: 26658126 DERIVED

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Venous Thromboembolism; Pulmonary Embolism; Venous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Thrombosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Jennifer McNulty
• Organization: Memorial Care

jjmcnulty@sbcglobal.net

562-933-2730

Study Officials

• Jennifer McNulty, MD

  Memorial Care Health System

  PRINCIPAL INVESTIGATOR

• Megan L Stephenson, MD

  Memorial Health Care System; University of California Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 25, 2014
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 23, 2015
• Results First Posted: November 23, 2015

Record last verified: 2015-01

Locations

US (1)