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Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin

NCT03516656 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-17

No results posted yet for this study

Summary

The purpose of this study is to determine if weight-based heparin infusions at a rate of 10 units/kg/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for VTE prophylaxis in patients undergoing microvascular surgery. Additionally, a pilot protocol has been developed to titrate these heparin infusions to ensure patients have sufficient VTE prophylaxis. All patients will be enrolled in the observational arm of the study and receive anti-Xa level monitoring. Patients with out-of-range anti-Xa levels will cross over to the interventional arm of the study and receive real time heparin infusion dose adjustments per the pilot protocol. The primary outcome measured will be the percentage of patients with anti-Xa levels in the target range of 0.1-0.35 IU/mL while on a heparin infusion at 10 units/kg/hour.

Conditions

Interventions

DRUG

Standard heparin dose

Patients will be placed on heparin infusions per their surgeon's discretion.

DRUG

Real time heparin dose adjustment

Patients will have steady state anti-Xa levels drawn at least 6 hours after initiation of heparin infusion. Patients with out of range anti-Xa levels will receive real time heparin dose adjustment followed by repeat anti-Xa levels.

Sponsors & Collaborators

Principal Investigators

  • Anne Prazak, PharmD · University of Utah

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-23
Primary Completion
2019-06-30
Completion
2021-08-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516656 on ClinicalTrials.gov