Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Calcium heparin; Heparin

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.