Phase 4
N=46
Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)
Pregnancy Related · Antepartum DVT
Bottom Line
View on ClinicalTrials.gov: NCT04635839 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds). — 1; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Standard Dose of Unfractionated Heparin (Drug); Gestational Age-Based Dose of Unfractionated Heparin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Los Angeles
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds). |
1; 8 | — |
| SECONDARY Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism) |
1; 0 | — |
| SECONDARY Number of Participants Who Did Not Receive or Had a Delay of Neuraxial Anesthesia Due to Unfractionated Heparin |
0; 0 | — |
| SECONDARY Number of Participants That Received General Anesthesia |
1; 0 | — |
| SECONDARY Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin |
0; 0 | — |
| SECONDARY Maximum Anti-Factor Xa Level Measured |
0.09; 0.09 | — |
| SECONDARY Mode of Delivery |
6; 4; 14; 20 | — |
| SECONDARY Estimated Blood Loss From Delivery |
654; 593 | — |
| SECONDARY Number of Participants That Received a Blood Transfusion |
1; 7 | — |
| SECONDARY Maximum Activated Partial Thromboplastin Clotting Time Levels Measured |
26.6; 30.4 | — |
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.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT04635839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.