search
Back to results

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

Primary Purpose

Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Standard heparin dose
Real time heparin dose adjustment
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing surgical procedures
  • Initiation of a heparin infusion at a rate of 500 units/hour intraoperatively or postoperatively

Exclusion Criteria:

  • Age <18 years old
  • Pregnant
  • Incarcerated
  • Mentally disabled

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard heparin dose

Real time heparin dose adjustment

Arm Description

The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels. Eligible patients will be started on heparin fixed-dose intraoperatively and transitioned to a weight-based dose by their surgeons. Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL.

Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged

Outcomes

Primary Outcome Measures

Percentage of Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)

Secondary Outcome Measures

Number of Rate Adjustments

Full Information

First Posted
April 24, 2018
Last Updated
May 15, 2023
Sponsor
University of Utah
search

1. Study Identification

Unique Protocol Identification Number
NCT03516656
Brief Title
Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin
Official Title
Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard heparin dose
Arm Type
Active Comparator
Arm Description
The investigators will identify surgical patients placed on fixed dose heparin infusions at their attending surgeon's discretion-the proposed research will not dictate the initiation of the heparin drip intraoperatively. However, the investigators will identify patients already on heparin, evaluate steady state heparin anti-Xa levels and adjust patient's dose if necessary based on steady state anti-Xa levels. Eligible patients will be started on heparin fixed-dose intraoperatively and transitioned to a weight-based dose by their surgeons. Steady state anti-Xa levels will be drawn at least 6 hours after initiation of heparin infusion. Goal anti-Xa levels will be 0.1-0.35 IU/mL.
Arm Title
Real time heparin dose adjustment
Arm Type
Active Comparator
Arm Description
Patients with identified out of range levels will receive pharmacist-driven real time heparin dose adjustment and will receive follow-up steady state anti-Xa levels. Anti-Xa level monitoring will be discontinued when in range peak levels are obtained, when heparin infusions are discontinued at surgeon discretion, or when the patient is discharged
Intervention Type
Drug
Intervention Name(s)
Standard heparin dose
Intervention Description
Patients will be placed on heparin infusions per their surgeon's discretion.
Intervention Type
Drug
Intervention Name(s)
Real time heparin dose adjustment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Number of Rate Adjustments
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing surgical procedures Initiation of a heparin infusion at a rate of 500 units/hour intraoperatively or postoperatively Exclusion Criteria: Age <18 years old Pregnant Incarcerated Mentally disabled
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Prazak, PharmD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs