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Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)

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ClinicalTrials.gov Identifier: NCT04635839
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Thalia Wong, MD, University of California, Los Angeles

Brief Summary:
This study is a randomized control trial to compare gestational age-based dosing with standard dosing of unfractionated heparin for thromboprophylaxis of hospitalized antepartum patients. The investigators aim to determine the effect of dosing on receipt of neuraxial anesthesia and pregnancy outcomes and evaluate the pharmacokinetics and pharmacodynamics of unfractionated heparin in pregnancy.

Condition or disease Intervention/treatment Phase
Pregnancy Related Antepartum DVT Drug: Standard Dose of Unfractionated Heparin Drug: Gestational Age-Based Dose of Unfractionated Heparin Not Applicable

Detailed Description:
Venous thromboembolism is one of the leading causes of maternal morbidity and mortality, and antepartum hospitalizations place pregnant patients at an even higher risk of developing thromboembolism. As a result, there is an increased emphasis on administering pharmacologic thromboprophylaxis for antepartum patients with prolonged hospitalizations. Previously, standard dosing of unfractionated heparin was widely adopted for thromboprophylaxis in the pregnant population. However, due to a suspected altered metabolism of unfractionated heparin in pregnancy resulting in a decrease response, the American College of Obstetricians and Gynecologists (ACOG) currently recommends considering gestational age-based dosing for unfractionated heparin for thromboprophylaxis in pregnancy with standard dosing as an alternative option. The data supporting altered dosing is very limited. In addition, increased dosing of heparin may result in challenges in anesthetic management, potentially limiting the receipt of neuraxial anesthesia resulting in increased need for general anesthesia associated with both increased maternal and fetal risks. The potential effects of higher prophylactic unfractionated heparin dosing in pregnant patients need to be further explored before being widely adopted for inpatient antepartum thromboprophylaxis. The investigators propose this study to provide a direct comparison of gestational age-based unfractionated heparin dosing to standard dosing of unfractionated heparin for pharmacologic thromboprophylaxis of hospitalized antepartum patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Control Trial of Unfractionated Heparin Thromboprophylaxis Dosing for Antepartum Hospitalizations
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: Standard Dosing
Standard dose of unfractionated heparin
Drug: Standard Dose of Unfractionated Heparin
5,000 units subcutaneous unfractionated heparin every 12 hours

Active Comparator: Gestational Age-Based Dosing
Dose of unfractionated heparin based on trimester of pregnancy
Drug: Gestational Age-Based Dose of Unfractionated Heparin
  • First trimester (< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours
  • Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours
  • Third trimester (> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours




Primary Outcome Measures :
  1. Elevated serum aPTT value above the normal range (> 36.2 seconds). [ Time Frame: From date of randomization through study completion, average 4 weeks ]
    Surrogate marker for whether or not the patient would be eligible for neuraxial anesthesia based on guidelines for neuraxial anesthesia in pregnant women receiving VTE prophylaxis


Secondary Outcome Measures :
  1. Diagnosis of venous thromboembolism (pulmonary embolism and/or deep venous thromboembolism) [ Time Frame: From date of randomization up to 6 weeks postpartum ]
  2. Nonreceipt or delay of neuraxial anesthesia due to unfractionated heparin [ Time Frame: From date of randomization through study completion, average 4 weeks ]
  3. Receipt of general anesthesia due to unfractionated heparin [ Time Frame: From date of randomization through study completion, average 4 weeks ]
  4. Delay in timing of delivery due to unfractionated heparin [ Time Frame: From date of randomization through study completion, average 4 weeks ]
  5. Anti-Xa levels [ Time Frame: From date of randomization through study completion, average 4 weeks ]
  6. Number of times adjustment in unfractionated heparin dose made [ Time Frame: From date of randomization through study completion, average 4 weeks ]
  7. Mode of delivery [ Time Frame: From date of randomization until date of delivery ]
  8. Estimated blood loss from delivery [ Time Frame: From date of randomization until 6 weeks postpartum ]
  9. Receipt of blood transfusion [ Time Frame: From date of randomization until 6 weeks postpartum ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Speak English or Spanish
  • Antepartum admission for at least 72 hours at Ronald Reagan UCLA Medical Center
  • Provides informed consent for study participation

Exclusion Criteria:

  • Active or threatened antenatal bleeding
  • Disseminated intravascular coagulation
  • Risk of imminent delivery (delivery within 12 hours)
  • Thrombocytopenia (platelet count < 100 x 109)
  • Elevated baseline aPTT (> 36.2 seconds)
  • Concern for hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome
  • Congenital bleeding disorders (hemophilias)
  • Receiving therapeutic or prophylactic anticoagulation (unfractionated heparin, low molecular weight heparin, oral anticoagulants) for alternative indication (e.g., acquired or inherited thrombophilia, history of VTE)
  • History of heparin-induced thrombocytopenia (HIT)
  • SARS-CoV-2 positive
  • Cognitive impairment, psychiatric instability, or language barriers that limit their ability to provide informed consent
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635839


Contacts
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Contact: Thalia Wong, MD 310-210-2246 thaliawong@mednet.ucla.edu

Locations
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United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Thalia Wong, MD    650-862-7857    thaliawong@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
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Responsible Party: Thalia Wong, MD, Co-Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04635839    
Other Study ID Numbers: 20-001799
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Thalia Wong, MD, University of California, Los Angeles:
Thromboprophylaxis
Antepartum admission
Heparin
Additional relevant MeSH terms:
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Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action