Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)
Study Details
Study Description
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 |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Elevated serum aPTT value above the normal range (> 36.2 seconds). [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
- Diagnosis of venous thromboembolism (pulmonary embolism and/or deep venous thromboembolism) [From date of randomization up to 6 weeks postpartum]
- Nonreceipt or delay of neuraxial anesthesia due to unfractionated heparin [From date of randomization through study completion, average 4 weeks]
- Receipt of general anesthesia due to unfractionated heparin [From date of randomization through study completion, average 4 weeks]
- Delay in timing of delivery due to unfractionated heparin [From date of randomization through study completion, average 4 weeks]
- Anti-Xa levels [From date of randomization through study completion, average 4 weeks]
- Number of times adjustment in unfractionated heparin dose made [From date of randomization through study completion, average 4 weeks]
- Mode of delivery [From date of randomization until date of delivery]
- Estimated blood loss from delivery [From date of randomization until 6 weeks postpartum]
- Receipt of blood transfusion [From date of randomization until 6 weeks postpartum]
Eligibility Criteria
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)
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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)
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History of heparin-induced thrombocytopenia (HIT)
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SARS-CoV-2 positive
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Cognitive impairment, psychiatric instability, or language barriers that limit their ability to provide informed consent
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA Medical Center | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-001799