Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)

NCT04635839 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20-001799
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Antepartum DVT

Keywords

Thromboprophylaxis; Antepartum admission; Heparin

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds).

  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

  Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week

Secondary Outcomes (9)

• Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism)

  Assessed throughout hospitalization, an average length of 8 days, until 6 weeks after delivery

• Number of Participants Who Did Not Receive or Had a Delay of Neuraxial Anesthesia Due to Unfractionated Heparin

  Assessed at time of delivery

• Number of Participants That Received General Anesthesia

  Assessed at time of delivery

• Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin

  Assessed at time of delivery

• Maximum Anti-Factor Xa Level Measured

  Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week

Study Arms (2)

Standard Dosing

ACTIVE COMPARATOR

Standard dose of unfractionated heparin

Drug: Standard Dose of Unfractionated Heparin

Gestational Age-Based Dosing

ACTIVE COMPARATOR

Dose of unfractionated heparin based on trimester of pregnancy

Drug: Gestational Age-Based Dose of Unfractionated Heparin

Interventions

Standard Dose of Unfractionated Heparin DRUG

5,000 units subcutaneous unfractionated heparin every 12 hours

Standard Dosing

Gestational Age-Based Dose of Unfractionated Heparin DRUG

* 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

Gestational Age-Based Dosing

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Mok T, Nguyen AV, Kwan L, Steinberg I, Vallera C, Silverman NS, Rao R. Prophylactic Unfractionated Heparin in Antepartum Hospitalizations: A Randomized Controlled Trial. Obstet Gynecol. 2024 Jul 1;144(1):118-125. doi: 10.1097/AOG.0000000000005599. Epub 2024 May 14.

  PMID: 38743958 DERIVED

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Thalia Mok
• Organization: University of California, Los Angeles

tmok@mednet.ucla.edu

310-794-7274

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 19, 2020
• Study Start: December 15, 2020
• Primary Completion: March 31, 2022
• Study Completion: May 1, 2022
• Last Updated: April 28, 2023
• Results First Posted: April 28, 2023

Record last verified: 2023-04

Locations

US (1)